Prescription drug · NDA
Aminosyn-PF NDC 0990-4179
Isoleucine 760 mg/100mL + 17 more ingredients · Injection, Solution · Intravenous · ICU Medical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0990-4179-05 | 00990417905 | 6 BAG in 1 CASE (0990-4179-05) / 1000 mL in 1 BAGMarketed from Nov 1, 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)
- 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 — 760 mg/100mLLeucine — 1200 mg/100mLLysine acetate — 677 mg/100mLMethionine — 180 mg/100mLPhenylalanine — 427 mg/100mLThreonine — 512 mg/100mLTryptophan — 180 mg/100mLValine — 673 mg/100mLAlanine — 698 mg/100mLArginine — 1227 mg/100mLAspartic acid — 527 mg/100mLGlutamic acid — 820 mg/100mLGlycine — 385 mg/100mLHistidine — 312 mg/100mLProline — 812 mg/100mLSerine — 495 mg/100mLTaurine — 70 mg/100mLTyrosine — 44 mg/100mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- ICU Medical Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019492
- Marketing start
- Listing expires
- Other FDA classes
- Amino Acids (Chemical structure)
- Identifiers
- Product ID 0990-4179_549fb8fe-b1b4-4b40-b078-2511913c2d43SPL ID 549fb8fe-b1b4-4b40-b078-2511913c2d43SPL set ID 46e74ce4-cd7e-437f-bf54-ca9b98eb2663RxCUI 800341, 800345UNII 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
N400990417905followed by a unit qualifier and the quantityPackage 00990-4179-05. 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 Aminosyn-PF 10%, 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 10% 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 inc…
Excerpt only. Read the full label for complete information.