NDC codes

FDA NDC Directory
Product NDC (as listed)0264-4500Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00264-4500Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0264-4500-0000264450000002644500008 CONTAINER in 1 CASE (0264-4500-00) / 1000 mL in 1 CONTAINERMarketed from Sep 28, 2018
0264-4500-0500264450005002644500054 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.

How CPT relates to drug billing

NDC on a medical claim

N400264450000 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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