Prescription drug · NDA
Aminosyn-PF NDC 0990-4178
Isoleucine 534 mg/100mL + 17 more ingredients · Injection, Solution · Intravenous · ICU Medical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0990-4178-03 | 00990417803 | 12 BAG in 1 CASE (0990-4178-03) / 500 mL in 1 BAGMarketed from Oct 1, 2021 |
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)
- Aminosyn-PF
- Generic name (nonproprietary)
- isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosine
- Active ingredients
- Isoleucine — 534 mg/100mLLeucine — 831 mg/100mLLysine acetate — 475 mg/100mLMethionine — 125 mg/100mLPhenylalanine — 300 mg/100mLThreonine — 360 mg/100mLTryptophan — 125 mg/100mLValine — 452 mg/100mLAlanine — 490 mg/100mLArginine — 861 mg/100mLAspartic acid — 370 mg/100mLGlutamic acid — 576 mg/100mLGlycine — 270 mg/100mLHistidine — 220 mg/100mLProline — 570 mg/100mLSerine — 347 mg/100mLTaurine — 50 mg/100mLTyrosine — 44 mg/100mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- ICU Medical Inc.NDC labeler code 0990
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019398
- Marketing start
- Listing expires
- Other FDA classes
- Amino Acids (Chemical structure)
- Identifiers
- Product ID 0990-4178_33d8e12a-620f-41d0-bdca-3a18fc0c20cbSPL ID 33d8e12a-620f-41d0-bdca-3a18fc0c20cbSPL set ID 2d212e10-7e08-4aeb-b63f-dcc927897769RxCUI 831426, 831430UNII 04Y7590D77, GMW67QNF9C, TTL6G7LIWZ, AE28F7PNPL, 47E5O17Y3R, 2ZD004190S, 8DUH1N11BX, HG18B9YRS7, OF5P57N2ZX, 94ZLA3W45F, 30KYC7MIAI, 3KX376GY7L, TE7660XO1C, 4QD397987E, 9DLQ4CIU6V, 452VLY9402, 1EQV5MLY3D, 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
N400990417803followed by a unit qualifier and the quantityPackage 00990-4178-03. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) 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 Aminosyn-PF 7% 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 incre…
Excerpt only. Read the full label for complete information.
About NDC 0990-4178
- What is NDC 0990-4178?
- 0990-4178 is the product NDC for Aminosyn-PF, Isoleucine 534 mg/100mL + 17 more ingredients injection, solution, listed with the FDA by ICU Medical Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Aminosyn-PF (ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE).
- What is the active ingredient?
- Isoleucine, Leucine, Lysine acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic acid, Glutamic acid, Glycine, Histidine, Proline, Serine, Taurine, Tyrosine.
- Who is the labeler?
- ICU Medical Inc., NDC labeler code 0990. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Aminosyn-PF?
- 1 other product NDC are listed under this name. See all Aminosyn-PF NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Aminosyn-PF products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Aminosyn-PFisoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosine | Isoleucine 760 mg/100mL + 17 more ingredients | Injection, SolutionIntravenous | ICU Medical Inc. | 0990-4179 | 00990-4179-05 |