Prescription drug · ANDA
Premasol - sulfite-free (Amino Acid) NDC 0338-1130
Leucine 1.4 g/100mL + 18 more ingredients · Injection, Solution · Intravenous · Baxter Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-1130-03 | 00338113003 | 500 mL in 1 BAG (0338-1130-03)Marketed from Jun 19, 2003 | |
| 0338-1130-04 | 00338113004 | 1000 mL in 1 BAG (0338-1130-04)Marketed from Jun 19, 2003 | |
| 0338-1130-06 | 00338113006 | 2000 mL in 1 BAG (0338-1130-06)Marketed from Jun 19, 2003 |
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)
- Premasol - sulfite-free (Amino Acid)
- Generic name (nonproprietary)
- leucine, lysine, isoleucine, valine, histidine, phenylalanine, threonine, methionine, tryptophan, tyrosine, n-acetyl-tyrosine, arginine, proline, alanine, glutamic acide, serine, glycine, aspartic acid, taurine, cysteine hydrochloride
- Active ingredients
- Leucine — 1.4 g/100mLLysine acetate — .82 g/100mLIsoleucine — .82 g/100mLValine — .78 g/100mLHistidine — .48 g/100mLPhenylalanine — .48 g/100mLThreonine — .42 g/100mLMethionine — .34 g/100mLTryptophan — .2 g/100mLTyrosine — .24 g/100mLArginine — 1.2 g/100mLProline — .68 g/100mLAlanine — .54 g/100mLGlutamic acid — .5 g/100mLSerine — .38 g/100mLGlycine — .36 g/100mLAspartic acid — .32 g/100mLTaurine — 25 mg/100mLCysteine hydrochloride — .016 g/100mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Baxter Healthcare Company
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075880
- Marketing start
- Listing expires
- Other FDA classes
- Amino Acids (Chemical structure)
- Identifiers
- Product ID 0338-1130_c874a813-b145-4f7f-833e-97d6c4dd727cSPL ID c874a813-b145-4f7f-833e-97d6c4dd727cSPL set ID 9afdcc3e-0d06-47f4-86ca-40da48b2b02bRxCUI 801395, 801398, 801403, 801405UNII GMW67QNF9C, TTL6G7LIWZ, 04Y7590D77, HG18B9YRS7, 4QD397987E, 47E5O17Y3R, 2ZD004190S, AE28F7PNPL, 8DUH1N11BX, 42HK56048U, 94ZLA3W45F, 9DLQ4CIU6V, OF5P57N2ZX, 3KX376GY7L, 452VLY9402, TE7660XO1C, 30KYC7MIAI, 1EQV5MLY3D, ZT934N0X4W
- 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
N400338113003followed by a unit qualifier and the quantityPackage 00338-1130-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE PREMASOL 10% injection is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with PREMASOL 10% injection is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, rou…
Excerpt only. Read the full label for complete information.