NDC 0264-3200

Plenamine

Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine

Plenamine is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by B. Braun Medical Inc.. The primary component is Lysine Acetate; Leucine; Phenylalanine; Valine; Isoleucine; Methionine; Threonine; Tryptophan; Alanine; Arginine; Glycine; Histidine; Proline; Glutamic Acid; Serine; Aspartic Acid; Tyrosine.

Product ID0264-3200_47fda1c9-721f-470e-9c13-261dd96f9200
NDC0264-3200
Product TypeHuman Prescription Drug
Proprietary NamePlenamine
Generic NameLysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine
Dosage FormSolution
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-01-30
Marketing CategoryANDA / ANDA
Application NumberANDA091112
Labeler NameB. Braun Medical Inc.
Substance NameLYSINE ACETATE; LEUCINE; PHENYLALANINE; VALINE; ISOLEUCINE; METHIONINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; HISTIDINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE
Active Ingredient Strength1 g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharm ClassesAmino Acid [EPC],Amino Acids [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0264-3200-55

6 CARTON in 1 CASE (0264-3200-55) > 1 BOTTLE, GLASS in 1 CARTON > 1000 mL in 1 BOTTLE, GLASS
Marketing Start Date2015-01-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0264-3200-55 [00264320055]

Plenamine SOLUTION
Marketing CategoryANDA
Application NumberANDA091112
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-01-30

Drug Details

Active Ingredients

IngredientStrength
LYSINE ACETATE1.18 g/100mL

OpenFDA Data

SPL SET ID:a0aedcb7-8bf6-4e2b-a85a-dd8f1411dcfc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1601982
  • 800584
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Plenamine" or generic name "Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine"

    NDCBrand NameGeneric Name
    0264-3200PlenamineLYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE
    0264-3205PlenamineLYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE
    0264-4500PlenamineLYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE

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