NDC 0264-4500

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 ID: 0264-4500_5eebcaf6-ed9b-4d18-9280-c89f2c704d54
• NDC: 0264-4500
• Product Type: Human Prescription Drug
• Proprietary Name: Plenamine
• Generic Name: Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic Acid, Serine, Aspartic Acid, And Tyrosine
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-09-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091112
• Labeler Name: B. Braun Medical Inc.
• Substance Name: LYSINE ACETATE; LEUCINE; PHENYLALANINE; VALINE; ISOLEUCINE; METHIONINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; HISTIDINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE
• Active Ingredient Strength: 1 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 Classes: Amino Acid [EPC],Amino Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0264-4500-00

8 CONTAINER in 1 CASE (0264-4500-00) > 1000 mL in 1 CONTAINER

• Marketing Start Date: 2018-09-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0264-4500-00 [00264450000]

Plenamine SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA091112
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-09-28

NDC 0264-4500-05 [00264450005]

Plenamine SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA091112
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-10-29

Drug Details

Active Ingredients

Ingredient	Strength
LYSINE ACETATE	1.18 g/100mL

OpenFDA Data

• SPL SET ID: a3244d1a-45b0-4e4c-bd96-f0632d761a1f
• Manufacturer:
  • B. Braun Medical Inc.
• UNII:
  • OF5P57N2ZX
  • 42HK56048U
  • AE28F7PNPL
  • 2ZD004190S
  • 94ZLA3W45F
  • TTL6G7LIWZ
  • 3KX376GY7L
  • 47E5O17Y3R
  • 8DUH1N11BX
  • 9DLQ4CIU6V
  • 04Y7590D77
  • 4QD397987E
  • 452VLY9402
  • GMW67QNF9C
  • HG18B9YRS7
  • 30KYC7MIAI
  • TE7660XO1C
• RxNorm Concept Unique ID - RxCUI:
  • 1601982
  • 800584

Pharmacological Class

• 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"

NDC	Brand Name	Generic Name
0264-3200	Plenamine	LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE
0264-3205	Plenamine	LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE
0264-4500	Plenamine	LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE