NDC 0264-9010

FreAmine III

Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Glycine, Cysteine, Phosphoric Acid, And Sodium Bisulfite

FreAmine III is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by B. Braun Medical Inc.. The primary component is Isoleucine; Leucine; Lysine Acetate; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Alanine; Arginine; Histidine; Proline; Serine; Glycine; Cysteine Hydrochloride; Phosphoric Acid.

Product ID0264-9010_41168773-4a49-468f-a8a0-ff183ec8b5de
NDC0264-9010
Product TypeHuman Prescription Drug
Proprietary NameFreAmine III
Generic NameIsoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Glycine, Cysteine, Phosphoric Acid, And Sodium Bisulfite
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1971-09-24
Marketing CategoryNDA / NDA
Application NumberNDA016822
Labeler NameB. Braun Medical Inc.
Substance NameISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; GLYCINE; CYSTEINE HYDROCHLORIDE; PHOSPHORIC ACID
Active Ingredient Strength1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
Pharm ClassesAmino Acid [EPC],Amino Acids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0264-9010-55

6 CARTON in 1 CASE (0264-9010-55) > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER
Marketing Start Date1971-09-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0264-9010-55 [00264901055]

FreAmine III INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA016822
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1971-09-24

Drug Details

Active Ingredients

IngredientStrength
ISOLEUCINE.69 g/100mL

OpenFDA Data

SPL SET ID:aa89dad1-bf4f-4f7e-ad1b-2431bdf36a2d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1014427
  • 1014431
  • Pharmacological Class

    • Amino Acid [EPC]
    • Amino Acids [CS]

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