plenamine

Generic: lysine acetate, leucine, phenylalanine, valine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, histidine, proline, glutamic acid, serine, aspartic acid, and tyrosine

Labeler: b. braun medical inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand 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
Labeler b. braun medical inc.
Dosage Form SOLUTION
Routes
INTRAVENOUS
Active Ingredients

alanine 2.17 g/100mL, arginine 1.47 g/100mL, aspartic acid 434 mg/100mL, glutamic acid 749 mg/100mL, glycine 1.04 g/100mL, histidine 894 mg/100mL, isoleucine 749 mg/100mL, leucine 1.04 g/100mL, lysine acetate 1.18 g/100mL, methionine 749 mg/100mL, phenylalanine 1.04 g/100mL, proline 894 mg/100mL, serine 592 mg/100mL, threonine 749 mg/100mL, tryptophan 250 mg/100mL, tyrosine 39 mg/100mL, valine 960 mg/100mL

Manufacturer
B. Braun Medical Inc.

Identifiers & Regulatory

Product NDC 0264-4500
Product ID 0264-4500_e55957d3-67af-4b6d-9232-55b654e0076f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091112
Listing Expiration 2026-12-31
Marketing Start 2018-09-28

Pharmacologic Class

Established (EPC)
amino acid [epc]
Chemical Structure
amino acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02644500
Hyphenated Format 0264-4500

Supplemental Identifiers

RxCUI
800584 1601982
UNII
OF5P57N2ZX 94ZLA3W45F 30KYC7MIAI 3KX376GY7L TE7660XO1C 4QD397987E 04Y7590D77 GMW67QNF9C TTL6G7LIWZ AE28F7PNPL 47E5O17Y3R 9DLQ4CIU6V 452VLY9402 2ZD004190S 8DUH1N11BX 42HK56048U HG18B9YRS7
NUI
N0000175780 M0000922

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name plenamine (source: ndc)
Generic Name lysine acetate, leucine, phenylalanine, valine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, histidine, proline, glutamic acid, serine, aspartic acid, and tyrosine (source: ndc)
Application Number ANDA091112 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2.17 g/100mL
  • 1.47 g/100mL
  • 434 mg/100mL
  • 749 mg/100mL
  • 1.04 g/100mL
  • 894 mg/100mL
  • 1.18 g/100mL
  • 592 mg/100mL
  • 250 mg/100mL
  • 39 mg/100mL
  • 960 mg/100mL
source: ndc
Packaging
  • 8 CONTAINER in 1 CASE (0264-4500-00) / 1000 mL in 1 CONTAINER
  • 4 CONTAINER in 1 CASE (0264-4500-05) / 2000 mL in 1 CONTAINER
source: ndc

Packages (2)

0264-4500-00 8 CONTAINER in 1 CASE (0264-4500-00) / 1000 mL in 1 CONTAINER 0264-4500-05 4 CONTAINER in 1 CASE (0264-4500-05) / 2000 mL in 1 CONTAINER

Ingredients (17)

alanine (2.17 g/100mL) arginine (1.47 g/100mL) aspartic acid (434 mg/100mL) glutamic acid (749 mg/100mL) glycine (1.04 g/100mL) histidine (894 mg/100mL) isoleucine (749 mg/100mL) leucine (1.04 g/100mL) lysine acetate (1.18 g/100mL) methionine (749 mg/100mL) phenylalanine (1.04 g/100mL) proline (894 mg/100mL) serine (592 mg/100mL) threonine (749 mg/100mL) tryptophan (250 mg/100mL) tyrosine (39 mg/100mL) valine (960 mg/100mL)

Linked Drug Pages (1)

Plenamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e55957d3-67af-4b6d-9232-55b654e0076f", "openfda": {"nui": ["N0000175780", "M0000922"], "unii": ["OF5P57N2ZX", "94ZLA3W45F", "30KYC7MIAI", "3KX376GY7L", "TE7660XO1C", "4QD397987E", "04Y7590D77", "GMW67QNF9C", "TTL6G7LIWZ", "AE28F7PNPL", "47E5O17Y3R", "9DLQ4CIU6V", "452VLY9402", "2ZD004190S", "8DUH1N11BX", "42HK56048U", "HG18B9YRS7"], "rxcui": ["800584", "1601982"], "spl_set_id": ["a3244d1a-45b0-4e4c-bd96-f0632d761a1f"], "pharm_class_cs": ["Amino Acids [CS]"], "pharm_class_epc": ["Amino Acid [EPC]"], "manufacturer_name": ["B. Braun Medical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 CONTAINER in 1 CASE (0264-4500-00)  / 1000 mL in 1 CONTAINER", "package_ndc": "0264-4500-00", "marketing_start_date": "20180928"}, {"sample": false, "description": "4 CONTAINER in 1 CASE (0264-4500-05)  / 2000 mL in 1 CONTAINER", "package_ndc": "0264-4500-05", "marketing_start_date": "20191029"}], "brand_name": "Plenamine", "product_id": "0264-4500_e55957d3-67af-4b6d-9232-55b654e0076f", "dosage_form": "SOLUTION", "pharm_class": ["Amino Acid [EPC]", "Amino Acids [CS]"], "product_ndc": "0264-4500", "generic_name": "LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE", "labeler_name": "B. Braun Medical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Plenamine", "active_ingredients": [{"name": "ALANINE", "strength": "2.17 g/100mL"}, {"name": "ARGININE", "strength": "1.47 g/100mL"}, {"name": "ASPARTIC ACID", "strength": "434 mg/100mL"}, {"name": "GLUTAMIC ACID", "strength": "749 mg/100mL"}, {"name": "GLYCINE", "strength": "1.04 g/100mL"}, {"name": "HISTIDINE", "strength": "894 mg/100mL"}, {"name": "ISOLEUCINE", "strength": "749 mg/100mL"}, {"name": "LEUCINE", "strength": "1.04 g/100mL"}, {"name": "LYSINE ACETATE", "strength": "1.18 g/100mL"}, {"name": "METHIONINE", "strength": "749 mg/100mL"}, {"name": "PHENYLALANINE", "strength": "1.04 g/100mL"}, {"name": "PROLINE", "strength": "894 mg/100mL"}, {"name": "SERINE", "strength": "592 mg/100mL"}, {"name": "THREONINE", "strength": "749 mg/100mL"}, {"name": "TRYPTOPHAN", "strength": "250 mg/100mL"}, {"name": "TYROSINE", "strength": "39 mg/100mL"}, {"name": "VALINE", "strength": "960 mg/100mL"}], "application_number": "ANDA091112", "marketing_category": "ANDA", "marketing_start_date": "20180928", "listing_expiration_date": "20261231"}