Drug company (FDA labeler)
Henry Schein, Inc.
NDC labeler code: 0404
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 16 products
- Bupivacaine hydrochlorideSensorcaine Mpf, Marcaine, Sensorcaine · 8 products
- Lidocaine hydrochloride and epinephrineXylocaine, Lignospan Standard, Flavalta · 6 products
- MidazolamNayzilam · 5 products
- GlycopyrrolateGlyrx-Pf, Glycate, Cuvposa · 4 products
- AtropineAtropen Auto-Injector, Isopto Atropine · 4 products
- Sodium chlorideBacteriostatic Sodium Chloride · 4 products
- WaterSterile Water, Bacteriostatic Water, Insulin Diluting Medium for Garzulys · 4 products
- Lidocaine hydrochloride,epinephrine bitartrateXylocaine, Xylocaine Mpf · 4 products
- Nalbuphine hydrochloride3 products
- DiazepamValium, Valtoco · 3 products
- Esmolol hydrochlorideBrevibloc, Esmolol Hydrochloride in Water · 3 products
- Dextrose monohydrateInfant Dextrose · 3 products
- DexamethasoneTaperdex 6-Day, Hemady, Taperdex 12-Day · 3 products
- EpinephrineAuvi-Q, Adrenalin, Adrenalin (Epinephrine in Sodium Chloride) · 3 products
- FurosemideLasix, Furoscix, Lasix Onyu · 3 products
- Magnesium sulfate heptahydrateMagnesium Sulfate in Water, Magnesium Sulfate in Dextrose, Magnesium Sulfate in 5% Dextrose · 3 products
- Promethazine hydrochloridePhenergan, Promethegan · 3 products
- Naloxone hydrochlorideNarcan, Rextovy, Zimhi · 3 products
- Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 3 products
- Cefazolin3 products
- Thiamine hydrochloride2 products
- Gentamicin sulfateGentak · 2 products
- MethylprednisoloneSolu-Medrol, Medrol · 2 products
- CyanocobalaminNascobal · 2 products
- Calcium gluconate2 products
- Aminophylline2 products
- Hydroxyzine2 products
- Ketamine hydrochlorideKetalar · 2 products
- Heparin sodiumHeparin Sodium and Dextrose · 2 products
- NitroglycerinNitrostat, Nitro-Dur, Nitroglycerin in Dextrose · 2 products
- PhenytoinDilantin, Phenytek, Phenytoin Infatabs · 2 products
- Flumazenil2 products
- Verapamil hydrochloride2 products
- Dopamine hydrochlorideDopamine Hydrochloride and Dextrose · 2 products
- Ampicillin2 products
- ClindamycinCleocin Phosphate, Cleocin Hydrochloride, Clindamycin Phoaphate Topical Solution Usp, 1% · 2 products
- PhytonadioneVitamin K1 · 2 products
- Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 2 products
- VancomycinTyzavan, Vancocin · 1 product
Show the other 31 medicines
- MethocarbamolRobaxin, Atmeksi, Tanlor · 1 product
- Amiodarone hydrochloridePacerone, Nexterone · 1 product
- MannitolOsmitrol · 1 product
- Calcium chloride1 product
- Bupivacaine hydrochloride and epinephrine bitartrateMarcaine with Epinephrine, Sensorcaine Mpf, Sensorcaine · 1 product
- DesfluraneSuprane · 1 product
- Aminocaproic acid1 product
- Dipyridamole1 product
- DoxycyclineDoxy 100, Acticlate Cap, Doryx Mpc · 1 product
- Haloperidol1 product
- Iron dextranInfed · 1 product
- Ondansetron1 product
- Terbutaline sulfate1 product
- Propranolol hydrochlorideInderal La, Inderal XL, Hemangeol · 1 product
- Hydralazine hydrochloride1 product
- Chlorpromazine hydrochloride1 product
- CosyntropinCortrosyn · 1 product
- DigoxinLanoxin · 1 product
- LincomycinLincocin · 1 product
- Ropivacaine hydrochlorideNaropin · 1 product
- PhenylephrineBiorphen, Immphentiv · 1 product
- Adenosine1 product
- Mepivacaine hydrochloridePolocaine, Polocaine-Mpf, Carbocaine · 1 product
- Trimethobenzamide hydrochlorideTigan · 1 product
- SuccinylcholineAnectine, Quelicin · 1 product
- MetronidazoleMetronidazole Vaginal, Metronidazole Vaginal Gel, Likmez · 1 product
- MetoclopramideReglan, Gimoti · 1 product
- Diphenhydramine1 product
- DexmedetomidinePrecedex, Dexmedetomidine in Dextrose, Igalmi · 1 product
- Sodium bicarbonate1 product
- EtomidateAmidate · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| September 19, 2024 | ANDA216049 | Nalbuphine hydrochloride NALBUPHINE HYDROCHLORIDE | Somerset Theraps LLC |
| February 29, 2024 | ANDA218404 | Naloxone hydrochloride NALOXONE HYDROCHLORIDE | Mankind Pharma |
| January 13, 2023 | ANDA215808 | Ketamine hydrochloride KETAMINE HYDROCHLORIDE | Fresenius Kabi USA |
| October 14, 2022 | ANDA213071 | Calcium gluconate CALCIUM GLUCONATE | Nivagen |
| August 15, 2022 | NDA211363 | Epinephrine EPINEPHRINE | Intl Medication Sys |
| May 26, 2022 | ANDA216120 | Atropine ATROPINE SULFATE | Am Regent |
| January 26, 2022 | ANDA215342 | Atropine ATROPINE SULFATE | Amneal |
| November 8, 2021 | ANDA214336 | Lidocaine LIDOCAINE HYDROCHLORIDE | Aspiro |
| April 28, 2021 | ANDA212248 | Sodium chloride SODIUM CHLORIDE 23.4% | Fresenius Kabi USA |
| May 4, 2020 | ANDA213810 | Succinylcholine SUCCINYLCHOLINE CHLORIDE | Aspiro |
| February 21, 2020 | ANDA210083 | Glycopyrrolate GLYCOPYRROLATE | Sagent |
| May 22, 2019 | ANDA207719 | Phytonadione PHYTONADIONE | DR Reddys |
| May 3, 2019 | ANDA212174 | Furosemide FUROSEMIDE | Eugia Pharma |
| February 25, 2019 | ANDA206191 | Metronidazole METRONIDAZOLE IN PLASTIC CONTAINER | Inforlife |
| December 18, 2018 | ANDA209255 | Cyanocobalamin CYANOCOBALAMIN | H2-Pharma |
| December 18, 2018 | ANDA209429 | Cyanocobalamin CYANOCOBALAMIN | Somerset Theraps LLC |
| October 25, 2018 | ANDA210842 | Glycopyrrolate GLYCOPYRROLATE | Piramal Critical |
| July 5, 2018 | ANDA211079 | Phenylephrine PHENYLEPHRINE HYDROCHLORIDE | Amneal |
| June 18, 2018 | ANDA211015 | Verapamil hydrochloride VERAPAMIL HYDROCHLORIDE | Somerset Theraps LLC |
| January 26, 2018 | NDA209260 | Atropine ATROPINE SULFATE | Fresenius Kabi USA |
| June 15, 2017 | NDA208418 | Calcium gluconate CALCIUM GLUCONATE, CALCIUM GLUCONATE IN SODIUM CHLORIDE | Fresenius Kabi USA |
| November 1, 2016 | ANDA204216 | Ketorolac tromethamine KETOROLAC TROMETHAMINE | Gland |
| May 27, 2016 | ANDA206128 | Methocarbamol METHOCARBAMOL | Eugia Pharma |
| March 4, 2016 | ANDA202981 | Sodium bicarbonate SODIUM BICARBONATE | Hospira |
| December 28, 2015 | ANDA203661 | Cefazolin CEFAZOLIN SODIUM | Qilu Antibiotics |
Show the other 97 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| September 2, 2015 | ANDA206369 | Water STERILE WATER FOR INJECTION | Hikma |
| July 23, 2015 | ANDA205520 | Esmolol hydrochloride ESMOLOL HYDROCHLORIDE | Eugia Pharma |
| June 4, 2015 | ANDA201746 | Lincomycin LINCOMYCIN HYDROCHLORIDE | Xgen Pharms |
| September 8, 2014 | ANDA203711 | Ondansetron ONDANSETRON HYDROCHLORIDE | Qilu Pharm Hainan |
| July 29, 2014 | NDA205029 | Epinephrine EPINEPHRINE | Bpi Labs |
| January 27, 2014 | ANDA202747 | Furosemide FUROSEMIDE | Baxter Hlthcare Corp |
| December 20, 2013 | ANDA204756 | Metoclopramide METOCLOPRAMIDE | Avet Lifesciences |
| March 14, 2013 | ANDA203082 | Lidocaine LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | Eugia Pharma |
| December 7, 2012 | NDA204200 | Epinephrine ADRENALIN | Ph Health |
| August 21, 2012 | ANDA091406 | Doxycycline DOXYCYCLINE | Mylan Labs Ltd |
| June 25, 2012 | ANDA091623 | Thiamine hydrochloride THIAMINE HYDROCHLORIDE | Mylan Institutional |
| September 30, 2011 | ANDA090108 | Clindamycin CLINDAMYCIN PHOSPHATE | Sagent Pharms Inc |
| August 17, 2010 | ANDA065499 | Ampicillin AMPICILLIN SODIUM | Eugia Pharma Speclts |
| June 30, 2010 | ANDA090808 | Heparin sodium HEPARIN SODIUM | Sagent Pharms |
| September 30, 2009 | ANDA088389 | Lidocaine hydrochloride and epinephrine LIGNOSPAN FORTE | Deproco |
| September 14, 2009 | ANDA078347 | Haloperidol HALOPERIDOL | Mylan Labs Ltd |
| March 23, 2009 | ANDA078527 | Flumazenil FLUMAZENIL | Hikma Farmaceutica |
| August 29, 2008 | ANDA040802 | Dexamethasone DEXAMETHASONE SODIUM PHOSPHATE | Mylan Labs Ltd |
| August 29, 2008 | ANDA040803 | Dexamethasone DEXAMETHASONE SODIUM PHOSPHATE | Mylan Labs Ltd |
| February 25, 2008 | ANDA077234 | Amiodarone hydrochloride AMIODARONE HYDROCHLORIDE | Hikma Farmaceutica |
| May 2, 2005 | ANDA076474 | Esmolol hydrochloride ESMOLOL HYDROCHLORIDE | Mylan Institutional |
| April 27, 2005 | ANDA077133 | Adenosine ADENOSINE | Fresenius Kabi USA |
| May 26, 2004 | ANDA076887 | Terbutaline sulfate TERBUTALINE SULFATE | Fresenius Kabi USA |
| July 22, 2002 | ANDA075857 | Midazolam MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | Hospira |
| September 18, 2001 | ANDA065047 | Cefazolin CEFAZOLIN SODIUM | Hikma Farmaceutica |
| August 31, 2001 | ANDA075826 | Propranolol hydrochloride PROPRANOLOL HYDROCHLORIDE | Fresenius Kabi USA |
| July 9, 2001 | NDA021146 | Atropine ATROPINE SULFATE | Hospira |
| March 13, 2001 | ANDA040388 | Hydralazine hydrochloride HYDRALAZINE HYDROCHLORIDE | Fresenius Kabi USA |
| June 20, 2000 | ANDA075243 | Midazolam MIDAZOLAM HYDROCHLORIDE | Hikma |
| June 20, 2000 | ANDA075293 | Midazolam MIDAZOLAM HYDROCHLORIDE | Hospira |
| May 1, 2000 | NDA021134 | Nitroglycerin NITROSTAT | Viatris |
| April 25, 2000 | ANDA075151 | Magnesium sulfate heptahydrate MAGNESIUM SULFATE | Hospira |
| January 28, 2000 | NDA021117 | Calcium chloride CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER | Hospira |
| December 17, 1999 | NDA021038 | Dexmedetomidine PRECEDEX | Hospira |
| October 20, 1998 | ANDA075136 | Verapamil hydrochloride VERAPAMIL HYDROCHLORIDE | Hospira |
| September 28, 1998 | ANDA040302 | Lidocaine LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER | Hospira |
| October 18, 1996 | ANDA074521 | Dipyridamole DIPYRIDAMOLE | Hikma |
| September 24, 1996 | NDA020533 | Ropivacaine hydrochloride NAROPIN | Fresenius Kabi USA |
| September 18, 1992 | NDA020118 | Desflurane SUPRANE | Baxter Hlthcare |
| February 3, 1989 | ANDA070914 | Nalbuphine hydrochloride NALBUPHINE HYDROCHLORIDE | Hospira |
| August 4, 1988 | ANDA062911 | Vancomycin VANCOMYCIN HYDROCHLORIDE | Hospira |
| June 21, 1988 | ANDA089635 | Lidocaine hydrochloride and epinephrine LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Hospira |
| June 21, 1988 | ANDA089644 | Lidocaine hydrochloride and epinephrine LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Hospira |
| June 21, 1988 | ANDA089646 | Lidocaine hydrochloride and epinephrine LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Hospira |
| May 24, 1988 | ANDA072034 | Nitroglycerin NITROGLYCERIN | Am Regent |
| March 24, 1988 | ANDA072076 | Naloxone hydrochloride NALOXONE HYDROCHLORIDE | Intl Medication |
| October 13, 1987 | ANDA071583 | Diazepam DIAZEPAM | Hospira |
| March 9, 1987 | ANDA070010 | Aminocaproic acid AMINOCAPROIC ACID IN PLASTIC CONTAINER | Hospira |
| March 3, 1987 | ANDA070597 | Bupivacaine hydrochloride BUPIVACAINE HYDROCHLORIDE | Hospira |
| February 17, 1987 | ANDA070590 | Bupivacaine hydrochloride BUPIVACAINE HYDROCHLORIDE | Hospira |
| December 31, 1986 | NDA019386 | Esmolol hydrochloride BREVIBLOC, BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, BREVIBLOC IN PLASTIC CONTAINER | Baxter Hlthcare |
| September 8, 1986 | NDA019316 | Magnesium sulfate heptahydrate MAGNESIUM SULFATE | Fresenius Kabi USA |
| June 3, 1986 | NDA019445 | Dextrose monohydrate DEXTROSE 25%, DEXTROSE 50% | Hospira |
| May 21, 1986 | ANDA070553 | Bupivacaine hydrochloride SENSORCAINE | Fresenius Kabi USA |
| April 18, 1986 | ANDA070172 | Naloxone hydrochloride NALOXONE HYDROCHLORIDE | Hospira |
| December 16, 1985 | ANDA070311 | Diazepam DIAZEPAM | Hikma |
| December 16, 1985 | ANDA070313 | Diazepam DIAZEPAM | Hikma |
| January 25, 1985 | ANDA088901 | Potassium chloride POTASSIUM CHLORIDE IN PLASTIC CONTAINER | Fresenius Kabi USA |
| January 22, 1985 | ANDA088390 | Lidocaine hydrochloride and epinephrine LIGNOSPAN STANDARD | Deproco |
| January 10, 1985 | ANDA088912 | Sodium chloride SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Fresenius Kabi USA |
| October 10, 1984 | ANDA088387 | Mepivacaine hydrochloride SCANDONEST PLAIN | Deproco |
| July 31, 1984 | ANDA088299 | Lidocaine LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER | Hospira |
| July 31, 1984 | ANDA088327 | Lidocaine LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER | Hospira |
| May 17, 1984 | ANDA088328 | Lidocaine LIDOCAINE HYDROCHLORIDE | Hospira |
| May 16, 1984 | ANDA088294 | Lidocaine LIDOCAINE HYDROCHLORIDE | Hospira |
| October 26, 1983 | ANDA087242 | Aminophylline AMINOPHYLLINE | Hospira |
| August 15, 1983 | ANDA062420 | Gentamicin sulfate GENTAMICIN SULFATE | Hospira |
| August 4, 1983 | ANDA062366 | Gentamicin sulfate GENTAMICIN SULFATE | Fresenius Kabi USA |
| October 29, 1982 | NDA018800 | Sodium chloride BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Hospira |
| October 29, 1982 | NDA018803 | Sodium chloride SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Hospira |
| October 27, 1982 | NDA018801 | Water STERILE WATER FOR INJECTION | Hospira |
| October 27, 1982 | NDA018802 | Water BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER | Hospira |
| September 7, 1982 | NDA018227 | Etomidate AMIDATE | Hospira |
| December 30, 1981 | NDA018304 | Bupivacaine hydrochloride and epinephrine bitartrate, Bupivacaine hydrochloride SENSORCAINE | Fresenius Kabi USA |
| August 27, 1981 | ANDA087408 | Hydroxyzine HYDROXYZINE HYDROCHLORIDE | Am Regent |
| May 19, 1981 | NDA018132 | Dopamine hydrochloride DOPAMINE HYDROCHLORIDE | Hospira |
| August 7, 1979 | ANDA086283 | Lidocaine LIDOCAINE HYDROCHLORIDE | Intl Medication |
| March 1, 1976 | ANDA083722 | Phytonadione PHYTONADIONE | Intl Medication |
| October 24, 1975 | ANDA083391 | Digoxin DIGOXIN | Hikma |
| July 16, 1975 | ANDA084307 | Phenytoin PHENYTOIN SODIUM | Hikma |
| July 15, 1975 | ANDA084282 | Dexamethasone DEXAMETHASONE SODIUM PHOSPHATE | Hikma |
| July 25, 1974 | ANDA083329 | Chlorpromazine hydrochloride CHLORPROMAZINE HYDROCHLORIDE | Hikma |
| July 12, 1974 | NDA017530 | Trimethobenzamide hydrochloride TIGAN | Ph Health |
| April 29, 1974 | NDA017441 | Iron dextran INFED | Allergan |
| February 26, 1974 | ANDA080571 | Thiamine hydrochloride THIAMINE HYDROCHLORIDE | DR Reddys |
| September 19, 1973 | ANDA083312 | Promethazine hydrochloride PROMETHAZINE HYDROCHLORIDE | Hikma |
| November 27, 1972 | ANDA080817 | Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE | West-Ward Pharms Int |
| October 3, 1972 | NDA016964 | Bupivacaine hydrochloride and epinephrine bitartrate, Bupivacaine hydrochloride MARCAINE HYDROCHLORIDE, MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | Hospira |
| October 2, 1972 | NDA050441 | Clindamycin CLEOCIN PHOSPHATE | Pfizer |
| September 28, 1972 | ANDA080408 | Lidocaine LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | Hospira |
| March 16, 1972 | ANDA080205 | Potassium chloride POTASSIUM CHLORIDE | Hospira |
| February 22, 1972 | NDA017029 | Heparin sodium HEPARIN SODIUM, HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%, HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% | Fresenius Kabi USA |
| April 22, 1970 | NDA016750 | Cosyntropin CORTROSYN | Amphastar Pharms Inc |
| February 19, 1970 | NDA016812 | Ketamine hydrochloride KETALAR | Ph Health |
| December 22, 1967 | NDA016269 | Mannitol MANNITOL 10%, MANNITOL 15%, MANNITOL 20% | Hospira |
| May 18, 1959 | NDA011856 | Methylprednisolone SOLU-MEDROL | Pharmacia and Upjohn |
| November 19, 1948 | NDA006488 | Lidocaine hydrochloride,epinephrine bitartrate, Lidocaine XYLOCAINE, XYLOCAINE W/ EPINEPHRINE | Fresenius Kabi USA |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2024
-
January 17, 2024 · Class II · Completed · D-0342-2024 · Epinephrine
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026