Drug company (FDA labeler)
ProPharma Distribution
NDC labeler code: 84549
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 · 7 products
- AtropineAtropen Auto-Injector, Isopto Atropine · 5 products
- GlycopyrrolateGlyrx-Pf, Glycate, Cuvposa · 4 products
- Rocuronium bromide3 products
- DexmedetomidinePrecedex, Dexmedetomidine in Dextrose, Igalmi · 3 products
- WaterSterile Water, Bacteriostatic Water, Insulin Diluting Medium for Garzulys · 3 products
- EpinephrineAuvi-Q, Adrenalin, Adrenalin (Epinephrine in Sodium Chloride) · 3 products
- Dextrose monohydrateInfant Dextrose · 3 products
- Sodium chlorideBacteriostatic Sodium Chloride · 3 products
- Dopamine hydrochlorideDopamine Hydrochloride and Dextrose · 3 products
- Magnesium sulfate heptahydrateMagnesium Sulfate in Water, Magnesium Sulfate in Dextrose, Magnesium Sulfate in 5% Dextrose · 2 products
- FurosemideLasix, Furoscix, Lasix Onyu · 2 products
- Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 2 products
- Sodium bicarbonate2 products
- NitroglycerinNitrostat, Nitro-Dur, Nitroglycerin in Dextrose · 2 products
- I.v. fat emulsionIntralipid, Nutrilipid I.V. Fat Emulsion · 2 products
- Flumazenil2 products
- Promethazine hydrochloridePhenergan, Promethegan · 2 products
- DexamethasoneTaperdex 6-Day, Hemady, Taperdex 12-Day · 2 products
- Naloxone hydrochlorideNarcan, Rextovy, Zimhi · 2 products
- Bupivacaine hydrochlorideSensorcaine Mpf, Marcaine, Sensorcaine · 2 products
- Adenosine2 products
- MethylprednisoloneSolu-Medrol, Medrol · 2 products
- Triamcinolone acetonideKenalog-40, Triderm, Triesence · 1 product
- Chloroprocaine hydrochlorideNesacaine Mpf, Nesacaine, Iheezo · 1 product
- Nalbuphine hydrochloride1 product
- Verapamil hydrochloride1 product
- Dantrolene sodiumRevonto, Dantrium, Ryanodex Dantrolene Sodium · 1 product
- Acetaminophen1 product
- Ephedrine sulfateEmerphed Pfs, Akovaz, Emerphed · 1 product
- MannitolOsmitrol · 1 product
- AcyclovirZovirax, Avaclyr · 1 product
- Neostigmine methylsulfateBloxiverz · 1 product
- CiprofloxacinCiprofloxacin in Dextrose, Cipro, Ciloxan · 1 product
- Vasopressin1 product
- MetoclopramideReglan, Gimoti · 1 product
- HydrocortisoneSolu-Cortef, Proctozone-Hc, Alkindi Sprinkle · 1 product
- Amiodarone hydrochloridePacerone, Nexterone · 1 product
- DiltiazemTiadylt ER, Cartia Xt, Tiazac Extended Release · 1 product
- Calcium gluconate1 product
- MetoprololToprol XL, Lopressor, Kapspargo · 1 product
- Ondansetron1 product
- Lidocaine hydrochloride anhydrous and dextrose monohydrate1 product
- Propranolol hydrochlorideInderal La, Inderal XL, Hemangeol · 1 product
- Aminophylline1 product
- FluorouracilFavlyxa, Tolak, Efudex · 1 product
- Esmolol hydrochlorideBrevibloc, Esmolol Hydrochloride in Water · 1 product
- Procainamide hydrochloride1 product
- ClindamycinCleocin Phosphate, Cleocin Hydrochloride, Clindamycin Phoaphate Topical Solution Usp, 1% · 1 product
- Diphenhydramine1 product
- Ampicillin1 product
- Cefazolin1 product
- SuccinylcholineAnectine, Quelicin · 1 product
- Calcium chloride1 product
- DigoxinLanoxin · 1 product
- SugammadexBridion · 1 product
- PhenytoinDilantin, Phenytek, Phenytoin Infatabs · 1 product
- Ropivacaine hydrochlorideNaropin · 1 product
- Lidocaine hydrochloride and epinephrineXylocaine, Lignospan Standard, Flavalta · 1 product
- Lidocaine hydrochloride,epinephrine bitartrateXylocaine, Xylocaine Mpf · 1 product
- Hydralazine hydrochloride1 product
- PhenylephrineBiorphen, Immphentiv · 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 |
|---|---|---|---|
| July 3, 2024 | ANDA215969 | Atropine ATROPINE SULFATE | Somerset Theraps LLC |
| June 28, 2023 | ANDA217594 | Sodium bicarbonate SODIUM BICARBONATE | Steriscience |
| June 16, 2023 | ANDA217692 | Lidocaine LIDOCAINE HYDROCHLORIDE | Mankind Pharma |
| March 2, 2023 | ANDA216234 | Rocuronium bromide ROCURONIUM BROMIDE | Caplin |
| November 4, 2022 | ANDA214970 | Atropine ATROPINE SULFATE | Medefil Inc |
| August 30, 2022 | ANDA217069 | Phenylephrine PHENYLEPHRINE HYDROCHLORIDE | Mankind Pharma |
| August 15, 2022 | ANDA214314 | Vasopressin VASOPRESSIN | Eugia Pharma |
| August 15, 2022 | NDA211363 | Epinephrine EPINEPHRINE | Intl Medication Sys |
| June 15, 2022 | ANDA214653 | Verapamil hydrochloride VERAPAMIL HYDROCHLORIDE | Mankind Pharma |
| May 26, 2022 | ANDA216120 | Atropine ATROPINE SULFATE | Am Regent |
| April 14, 2022 | ANDA216129 | Ephedrine sulfate EPHEDRINE SULFATE | Mankind Pharma |
| January 19, 2022 | ANDA213543 | Triamcinolone acetonide TRIAMCINOLONE ACETONIDE | Long Grove Pharms |
| February 18, 2021 | NDA204957 | Acetaminophen ACETAMINOPHEN | B Braun Medical |
| October 5, 2020 | ANDA212461 | Atropine ATROPINE SULFATE | Intl Medication Sys |
| January 15, 2020 | ANDA211589 | Succinylcholine SUCCINYLCHOLINE CHLORIDE | Somerset Theraps LLC |
| October 16, 2019 | ANDA212968 | Neostigmine methylsulfate NEOSTIGMINE METHYLSULFATE | Gland |
| January 18, 2019 | ANDA204843 | Dexmedetomidine DEXMEDETOMIDINE HYDROCHLORIDE | Meitheal |
| October 31, 2018 | ANDA210927 | Glycopyrrolate GLYCOPYRROLATE | Prinston Inc |
| October 25, 2018 | ANDA210842 | Glycopyrrolate GLYCOPYRROLATE | Piramal Critical |
| August 22, 2018 | ANDA205723 | Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE | Micro Labs |
| June 15, 2018 | ANDA207636 | Ropivacaine hydrochloride ROPIVACAINE HYDROCHLORIDE | Somerset Theraps LLC |
| May 9, 2018 | ANDA203477 | Calcium chloride CALCIUM CHLORIDE 10% | Intl Medication Sys |
| April 11, 2018 | ANDA207707 | Dopamine hydrochloride DOPAMINE HYDROCHLORIDE | Hikma Intl Pharms |
| April 4, 2018 | ANDA205656 | Rocuronium bromide ROCURONIUM BROMIDE | Gland |
| February 16, 2018 | ANDA206778 | Adenosine ADENOSINE | Gland |
| January 26, 2018 | NDA209260 | Atropine ATROPINE SULFATE | Fresenius Kabi USA |
| September 19, 2017 | ANDA203449 | Sodium bicarbonate SODIUM BICARBONATE | Intl Medication Sys |
| September 19, 2017 | ANDA206391 | Nitroglycerin NITROGLYCERIN | Glenmark Speclt |
| September 19, 2017 | ANDA209065 | Dexmedetomidine DEXMEDETOMIDINE HYDROCHLORIDE | Hengrui Pharma |
| August 8, 2017 | ANDA207633 | Naloxone hydrochloride NALOXONE HYDROCHLORIDE | Somerset Theraps LLC |
| July 26, 2017 | ANDA207634 | Naloxone hydrochloride NALOXONE HYDROCHLORIDE | Somerset Theraps LLC |
| 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 |
| October 21, 2016 | ANDA207449 | Dextrose monohydrate DEXTROSE 5% IN PLASTIC CONTAINER | Fresenius Kabi USA |
| December 28, 2015 | ANDA203661 | Cefazolin CEFAZOLIN SODIUM | Qilu Antibiotics |
| December 15, 2015 | NDA022225 | Sugammadex BRIDION | Msd Sub Merck |
| August 20, 2015 | ANDA202126 | Dexmedetomidine DEXMEDETOMIDINE HYDROCHLORIDE | Gland |
| July 23, 2015 | ANDA205520 | Esmolol hydrochloride ESMOLOL HYDROCHLORIDE | Eugia Pharma |
| September 8, 2014 | ANDA203711 | Ondansetron ONDANSETRON HYDROCHLORIDE | Qilu Pharm Hainan |
| August 26, 2014 | ANDA203428 | Furosemide FUROSEMIDE | Avet Lifesciences |
| July 29, 2014 | NDA205029 | Epinephrine EPINEPHRINE | Bpi Labs |
| October 11, 2013 | ANDA203701 | Acyclovir ACYCLOVIR SODIUM | Eugia Pharma |
| December 7, 2012 | NDA204200 | Epinephrine ADRENALIN | Ph Health |
| August 17, 2010 | ANDA065499 | Ampicillin AMPICILLIN SODIUM | Eugia Pharma Speclts |
| March 23, 2009 | ANDA078527 | Flumazenil FLUMAZENIL | Hikma Farmaceutica |
| August 29, 2008 | ANDA040803 | Dexamethasone DEXAMETHASONE SODIUM PHOSPHATE | Mylan Labs Ltd |
| April 29, 2008 | ANDA078085 | Metoprolol METOPROLOL TARTRATE | Hospira |
| April 24, 2008 | ANDA040737 | Promethazine hydrochloride PROMETHAZINE HYDROCHLORIDE | Xgen Pharms |
| March 18, 2008 | ANDA078252 | Ciprofloxacin CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | Inforlife |
| July 24, 2007 | ANDA078378 | Dantrolene sodium REVONTO | Uswm |
| June 14, 2007 | ANDA077283 | Adenosine ADENOSINE | Gland Pharma Ltd |
| October 15, 2002 | ANDA076217 | Amiodarone hydrochloride AMIODARONE HYDROCHLORIDE | Mylan Institutional |
| August 31, 2001 | ANDA075826 | Propranolol hydrochloride PROPRANOLOL HYDROCHLORIDE | Fresenius Kabi USA |
| March 13, 2001 | ANDA040388 | Hydralazine hydrochloride HYDRALAZINE HYDROCHLORIDE | Fresenius Kabi USA |
| September 30, 1998 | ANDA040279 | Fluorouracil FLUOROURACIL | Fresenius Kabi USA |
| September 28, 1998 | ANDA040302 | Lidocaine LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER | Hospira |
| September 9, 1998 | ANDA040273 | Chloroprocaine hydrochloride CHLOROPROCAINE HYDROCHLORIDE | Hikma |
| February 28, 1996 | ANDA074617 | Diltiazem DILTIAZEM HYDROCHLORIDE | Sagent |
| June 23, 1995 | ANDA040078 | Lidocaine LIDOCAINE HYDROCHLORIDE | Hospira |
| April 8, 1992 | NDA019830 | Lidocaine hydrochloride anhydrous and dextrose monohydrate LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | B Braun |
| January 17, 1991 | ANDA073118 | Metoclopramide METOCLOPRAMIDE HYDROCHLORIDE | Hospira |
| December 29, 1989 | NDA019970 | Nitroglycerin NITROGLYCERIN IN DEXTROSE 5% | Baxter Hlthcare |
| February 3, 1989 | ANDA070915 | Nalbuphine hydrochloride NALBUPHINE HYDROCHLORIDE | Hospira |
| June 21, 1988 | ANDA089646 | Lidocaine hydrochloride and epinephrine LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Hospira |
| February 29, 1988 | NDA019633 | Water STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | B Braun |
| March 27, 1987 | NDA019615 | Dopamine hydrochloride DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | Baxter Hlthcare |
| February 17, 1987 | ANDA070583 | Bupivacaine hydrochloride BUPIVACAINE HYDROCHLORIDE | Hospira |
| February 17, 1987 | ANDA070584 | Bupivacaine hydrochloride BUPIVACAINE HYDROCHLORIDE | Hospira |
| September 8, 1986 | NDA019316 | Magnesium sulfate heptahydrate MAGNESIUM SULFATE | Fresenius Kabi USA |
| June 3, 1986 | NDA019445 | Dextrose monohydrate DEXTROSE 25%, DEXTROSE 50% | Hospira |
| July 31, 1984 | ANDA088299 | Lidocaine LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER | Hospira |
| July 31, 1984 | ANDA088327 | Lidocaine LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER | Hospira |
| July 31, 1984 | ANDA088636 | Procainamide hydrochloride PROCAINAMIDE HYDROCHLORIDE | Intl Medication |
| October 26, 1983 | ANDA087242 | Aminophylline AMINOPHYLLINE | Hospira |
| 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 |
| May 19, 1981 | NDA018132 | Dopamine hydrochloride DOPAMINE HYDROCHLORIDE | Hospira |
| January 23, 1981 | NDA018449 | I.v. fat emulsion INTRALIPID 20% | Fresenius |
| October 24, 1975 | ANDA083391 | Digoxin DIGOXIN | Hikma |
| July 16, 1975 | ANDA084307 | Phenytoin PHENYTOIN SODIUM | Hikma |
| September 19, 1973 | ANDA083312 | Promethazine hydrochloride PROMETHAZINE HYDROCHLORIDE | Hikma |
| October 2, 1972 | NDA050441 | Clindamycin CLEOCIN PHOSPHATE | Pfizer |
| August 11, 1972 | ANDA080677 | Mannitol MANNITOL 25% | Fresenius Kabi USA |
| December 9, 1970 | NDA016677 | Sodium chloride SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Baxter Hlthcare |
| May 18, 1959 | NDA011856 | Methylprednisolone SOLU-MEDROL | Pharmacia and Upjohn |
| April 27, 1955 | NDA009866 | Hydrocortisone SOLU-CORTEF | 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
No recall of these products (by NDC code) appears in the FDA enforcement reports.
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