Prescription drug · ANDA
Plenamine NDC 0264-4500
Lysine acetate 1.18 g/100mL + 16 more ingredients · Solution · Intravenous · B. Braun Medical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0264-4500-00 | 0026445000000264450000 | 8 CONTAINER in 1 CASE (0264-4500-00) / 1000 mL in 1 CONTAINERMarketed from Sep 28, 2018 | |
| 0264-4500-05 | 0026445000500264450005 | 4 CONTAINER in 1 CASE (0264-4500-05) / 2000 mL in 1 CONTAINERMarketed from Oct 29, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Plenamine
- Generic name (nonproprietary)
- lysine acetate, leucine, phenylalanine, valine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, histidine, proline, glutamic acid, serine, aspartic acid, and tyrosine
- Active ingredients
- Lysine acetate — 1.18 g/100mLLeucine — 1.04 g/100mLPhenylalanine — 1.04 g/100mLValine — 960 mg/100mLIsoleucine — 749 mg/100mLMethionine — 749 mg/100mLThreonine — 749 mg/100mLTryptophan — 250 mg/100mLAlanine — 2.17 g/100mLArginine — 1.47 g/100mLGlycine — 1.04 g/100mLHistidine — 894 mg/100mLProline — 894 mg/100mLGlutamic acid — 749 mg/100mLSerine — 592 mg/100mLAspartic acid — 434 mg/100mLTyrosine — 39 mg/100mL
- Dosage form
- Solution
- Route
- Intravenous
- Labeler
- B. Braun Medical Inc.NDC labeler code 0264
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091112
- Marketing start
- Listing expires
- Other FDA classes
- Amino Acids (Chemical structure)
- Identifiers
- Product ID 0264-4500_905f7c55-bf0d-4150-90ef-e8f1a5455bc1SPL ID 905f7c55-bf0d-4150-90ef-e8f1a5455bc1SPL set ID a3244d1a-45b0-4e4c-bd96-f0632d761a1fRxCUI 800584, 1601982UNII TTL6G7LIWZ, GMW67QNF9C, 47E5O17Y3R, HG18B9YRS7, 04Y7590D77, AE28F7PNPL, 2ZD004190S, 8DUH1N11BX, OF5P57N2ZX, 94ZLA3W45F, TE7660XO1C, 4QD397987E, 9DLQ4CIU6V, 3KX376GY7L, 452VLY9402, 30KYC7MIAI, 42HK56048U
- Pharmacologic class
- Amino Acid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400264450000followed by a unit qualifier and the quantityPackage 00264-4500-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Plenamine™ 15% is indicated as an amino acid (nitrogen) source in parenteral nutrition regimens. This use is appropriate when the enteral route is inadvisable, inadequate or not possible, as when: — Gastrointestinal absorption is impaired by obstruction, inflammatory disease or its complications, or antineoplastic therapy; — Bowel rest is needed because of gastrointestinal surgery or its complications such as ileus, fistulae or anastomotic leaks; — Tube feeding methods alone cannot provide adequate nutrition.
Excerpt only. Read the full label for complete information.
About NDC 0264-4500
- What is NDC 0264-4500?
- 0264-4500 is the product NDC for Plenamine, Lysine acetate 1.18 g/100mL + 16 more ingredients solution, listed with the FDA by B. Braun Medical Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Plenamine (LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE).
- What is the active ingredient?
- Lysine acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Histidine, Proline, Glutamic acid, Serine, Aspartic acid, Tyrosine.
- Who is the labeler?
- B. Braun Medical Inc., NDC labeler code 0264. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Plenamine?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.