Drug company (FDA labeler)
Baxter Healthcare Company
NDC labeler codes: 0338, 10019, 43066, 67108
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
- Leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseClinimix E · 18 products
- CyclophosphamideFrindovyx · 14 products
- Dextrose monohydrateInfant Dextrose · 9 products
- Dextrose monohydrate, sodium chloride, and potassium chloride8 products
- ClindamycinCleocin Phosphate, Cleocin Hydrochloride, Clindamycin Phoaphate Topical Solution Usp, 1% · 8 products
- Esmolol hydrochlorideBrevibloc, Esmolol Hydrochloride in Water · 7 products
- DexmedetomidinePrecedex, Dexmedetomidine in Dextrose, Igalmi · 6 products
- MesnaMesnex · 5 products
- Doxorubicin hydrochlorideDoxil, Doxorubicin Hydrochloride Liposome · 4 products
- Leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextroseClinimix E · 4 products
- Dextrose monohydrate and sodium chloride4 products
- IfosfamideIfex · 4 products
- NitroglycerinNitrostat, Nitro-Dur, Nitroglycerin in Dextrose · 3 products
- Pantoprazole sodiumProtonix I.V., Protonix Delayed-Release, Pantoprazole Sodium I.V. · 3 products
- Sodium chloride and potassium chloride3 products
- WaterSterile Water, Bacteriostatic Water, Insulin Diluting Medium for Garzulys · 2 products
- Sodium chloride, sodium lactate, potassium chloride, and calcium chlorideLactated Ringers, Lactated Ringers Irrigation · 2 products
- MannitolOsmitrol · 2 products
- Ceftriaxone sodiumCeftriaxone and Dextrose · 2 products
- SevofluraneUltane, Sevoflurane, (Volatile for Inhalation), Sojourn · 2 products
- FluconazoleDiflucan · 2 products
- Leucine, lysine, isoleucine, valine, histidine, phenylalanine, threonine, methionine, tryptophan, tyrosine, n-acetyl-tyrosine, arginine, proline, alanine, glutamic acide, serine, glycine, aspartic acid, taurine, cysteine hydrochloridePremasol - Sulfite-Free (Amino Acid) · 1 product
- Eptifibatide1 product
- Sodium chlorideBacteriostatic Sodium Chloride · 1 product
- Eribulin mesylateHalaven · 1 product
- Norepinephrine bitartrateLevophed · 1 product
- Potassium chloride, dextrose monohydrate1 product
- Sodium lactate, potassium chloride, magnesium chloride, monobasic potassium phosphate, sodium chloride and dextrose monohydrateDextrose and Electrolyte No. 48 · 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 |
|---|---|---|---|
| October 1, 2024 | ANDA217250 | Eribulin mesylate ERIBULIN MESYLATE | Baxter Hlthcare Corp |
| February 14, 2024 | NDA217512 | Pantoprazole sodium PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | Baxter Hlthcare Corp |
| June 27, 2023 | NDA217651 | Cyclophosphamide CYCLOPHOSPHAMIDE | Baxter Hlthcare Corp |
| May 6, 2021 | ANDA214323 | Norepinephrine bitartrate NOREPINEPHRINE BITARTRATE | Gland |
| November 23, 2018 | ANDA208554 | Eptifibatide EPTIFIBATIDE | Baxter Hlthcare Corp |
| August 21, 2018 | ANDA208532 | Dexmedetomidine DEXMEDETOMIDINE HYDROCHLORIDE | Baxter Hlthcare Corp |
| June 28, 2017 | ANDA208084 | Clindamycin CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | Baxter Hlthcare Corp |
| April 20, 2017 | NDA208083 | Clindamycin CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE | Baxter Hlthcare Corp |
| May 21, 2008 | ANDA040745 | Cyclophosphamide CYCLOPHOSPHAMIDE | Baxter Hlthcare |
| August 23, 2005 | ANDA065224 | Ceftriaxone sodium CEFTRIAXONE IN PLASTIC CONTAINER | Baxter Hlthcare |
| July 29, 2004 | ANDA076766 | Fluconazole FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Baxter Hlthcare |
| June 19, 2003 | ANDA075880 | Leucine, lysine, isoleucine, valine, histidine, phenylalanine, threonine, methionine, tryptophan, tyrosine, n-acetyl-tyrosine, arginine, proline, alanine, glutamic acide, serine, glycine, aspartic acid, taurine, cysteine hydrochloride PREMASOL 10% IN PLASTIC CONTAINER, PREMASOL 6% IN PLASTIC CONTAINER | Baxter Hlthcare |
| July 2, 2002 | ANDA075895 | Sevoflurane SEVOFLURANE | Baxter Hlthcare |
| March 21, 2002 | NDA020855 | Mesna MESNEX | Baxter Hlthcare |
| March 26, 1997 | NDA020678 | Leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose, Leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER, CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER, CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER | Baxter Hlthcare |
| November 17, 1995 | NDA050718 | Doxorubicin hydrochloride DOXIL (LIPOSOMAL) | Baxter Hlthcare Corp |
| December 7, 1992 | NDA020179 | Dextrose monohydrate DEXTROSE 5% IN PLASTIC CONTAINER | Baxter Hlthcare |
| December 29, 1989 | NDA019970 | Nitroglycerin NITROGLYCERIN IN DEXTROSE 5% | Baxter Hlthcare |
| December 30, 1988 | NDA019884 | Mesna MESNEX | Baxter Hlthcare |
| August 14, 1987 | NDA019763 | Ifosfamide IFEX, IFEX/MESNEX KIT | Baxter Hlthcare |
| December 31, 1986 | NDA019386 | Esmolol hydrochloride BREVIBLOC, BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, BREVIBLOC IN PLASTIC CONTAINER | Baxter Hlthcare |
| April 5, 1985 | NDA019308 | Dextrose monohydrate, sodium chloride, and potassium chloride POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Baxter Hlthcare |
| April 3, 1984 | NDA018921 | Sodium chloride, sodium lactate, potassium chloride, and calcium chloride LACTATED RINGER'S IN PLASTIC CONTAINER | Baxter Hlthcare |
| June 30, 1982 | NDA018632 | Water STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | Baxter Hlthcare |
| March 23, 1982 | NDA018629 | Dextrose monohydrate, sodium chloride, and potassium chloride DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER, DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | Baxter Hlthcare |
| May 30, 1980 | NDA017867 | Sodium chloride SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Baxter Hlthcare |
| February 2, 1979 | NDA017484 | Sodium lactate, potassium chloride, magnesium chloride, monobasic potassium phosphate, sodium chloride and dextrose monohydrate DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER | Baxter Hlthcare |
| February 2, 1979 | NDA017648 | Sodium chloride and potassium chloride POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%, POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9% | Baxter Hlthcare |
| February 2, 1979 | NDA018008 | Dextrose monohydrate, sodium chloride, and potassium chloride DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER, DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER, DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER | Baxter Hlthcare |
| February 2, 1979 | NDA018037 | Dextrose monohydrate, sodium chloride, and potassium chloride DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ | Baxter Hlthcare |
| February 1, 1979 | NDA017634 | Potassium chloride, dextrose monohydrate DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER | Baxter Hlthcare |
| March 22, 1971 | NDA016682 | Sodium chloride, sodium lactate, potassium chloride, and calcium chloride LACTATED RINGER'S IN PLASTIC CONTAINER | Baxter Hlthcare |
| March 22, 1971 | NDA016683 | Dextrose monohydrate and sodium chloride DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | Baxter Hlthcare |
| March 22, 1971 | NDA016697 | Dextrose monohydrate and sodium chloride DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | Baxter Hlthcare |
| December 9, 1970 | NDA016678 | Dextrose monohydrate and sodium chloride DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Baxter Hlthcare |
| December 8, 1970 | NDA016689 | Dextrose monohydrate and sodium chloride DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | Baxter Hlthcare |
| June 8, 1964 | NDA013684 | Mannitol OSMITROL 10% IN WATER, OSMITROL 10% IN WATER IN PLASTIC CONTAINER, OSMITROL 15% IN WATER | Baxter Hlthcare |
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