Plenamine
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- 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
- Manufacturer
- B. Braun Medical Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- a3244d1a-45b0-4e4c-bd96-f0632d761a1f
- SPL ID
- 905f7c55-bf0d-4150-90ef-e8f1a5455bc1
- Version
- 9
- Effective date
- 2026-05-08
- Source export date
- 2026-09-28
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:15:23
| Harmonized routes |
|---|
| INTRAVENOUS |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 091112 | derived:openfda.application_number |
| application number | ANDA091112 | openfda.application_number | |
| brand name | Plenamine | openfda.brand_name | |
| generic name | LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINE | openfda.generic_name | |
| manufacturer name | B. Braun Medical Inc. | openfda.manufacturer_name | |
| ndc | package | 0264-4500-00 | openfda.package_ndc |
| ndc | package | 0264-4500-05 | openfda.package_ndc |
| ndc | product | 0264-4500 | openfda.product_ndc |
| ndc11 | package | 00264450000 | derived:openfda.package_ndc |
| ndc11 | package | 00264450005 | derived:openfda.package_ndc |
| rxcui | 1601982 | openfda.rxcui | |
| rxcui | 800584 | openfda.rxcui | |
| spl id | 905f7c55-bf0d-4150-90ef-e8f1a5455bc1 | id | |
| spl set id | a3244d1a-45b0-4e4c-bd96-f0632d761a1f | set_id | |
| unii | 3KX376GY7L | openfda.unii | |
| unii | 8DUH1N11BX | openfda.unii | |
| unii | HG18B9YRS7 | openfda.unii | |
| unii | 42HK56048U | openfda.unii | |
| unii | 452VLY9402 | openfda.unii | |
| unii | OF5P57N2ZX | openfda.unii | |
| unii | 4QD397987E | openfda.unii | |
| unii | 04Y7590D77 | openfda.unii | |
| unii | TE7660XO1C | openfda.unii | |
| unii | 30KYC7MIAI | openfda.unii | |
| unii | GMW67QNF9C | openfda.unii | |
| unii | TTL6G7LIWZ | openfda.unii | |
| unii | AE28F7PNPL | openfda.unii | |
| unii | 47E5O17Y3R | openfda.unii | |
| unii | 2ZD004190S | openfda.unii | |
| unii | 9DLQ4CIU6V | openfda.unii | |
| unii | 94ZLA3W45F | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Administration of amino acids solutions at excessive rates or to patients with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. Conservative doses of amino acids should be given to these patients, dictated by the nutritional status of the patient. Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient's clinical status re-evaluated. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS (See WARNINGS , PRECAUTIONS and Special Precautions for Central Infusion .)
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.