Prescription drug · NDA
Aminosyn II NDC 0990-7171
Isoleucine 990 mg/100mL + 16 more ingredients · Injection, Solution · Intravenous · ICU Medical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0990-7171-17 | 00990717117 | 6 POUCH in 1 CASE (0990-7171-17) / 1 BAG in 1 POUCH / 2000 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 II
- Generic name (nonproprietary)
- isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine
- Active ingredients
- Isoleucine — 990 mg/100mLLeucine — 1500 mg/100mLLysine acetate — 1575 mg/100mLMethionine — 258 mg/100mLPhenylalanine — 447 mg/100mLThreonine — 600 mg/100mLTryptophan — 300 mg/100mLValine — 750 mg/100mLAlanine — 1490 mg/100mLArginine — 1527 mg/100mLAspartic acid — 1050 mg/100mLGlutamic acid — 1107 mg/100mLHistidine — 450 mg/100mLProline — 1083 mg/100mLSerine — 795 mg/100mLAcetyl l-tyrosine — 405 mg/100mLGlycine — 750 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 020041
- Marketing start
- Listing expires
- Other FDA classes
- Amino Acids (Chemical structure)
- Identifiers
- Product ID 0990-7171_0c99ec81-2c27-4352-8dbe-d7ec9e0e80e4SPL ID 0c99ec81-2c27-4352-8dbe-d7ec9e0e80e4SPL set ID 5b426208-f090-4650-86c3-89040ba45c2dRxCUI 800188, 800192, 800237, 800241UNII TTL6G7LIWZ, 9DLQ4CIU6V, 8DUH1N11BX, 47E5O17Y3R, OF5P57N2ZX, HG18B9YRS7, 94ZLA3W45F, 3KX376GY7L, TE7660XO1C, 4QD397987E, 452VLY9402, 04Y7590D77, GMW67QNF9C, 30KYC7MIAI, DA8G610ZO5, AE28F7PNPL, 2ZD004190S
- 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
N400990717117followed by a unit qualifier and the quantityPackage 00990-7171-17. 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 II, Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate. SUPPLEMENTAL ELECTROLYTES, IN ACCORDANCE WITH THE PRESCRIPTION OF THE ATTENDING PHYSICIAN, MUST BE ADDED TO AMINOSYN II SOLUTIONS WITHOUT ELECTROLYTES. Aminosyn II can be administered peripherally with dilute (5 to 10%) dextrose solution and I.V. fat emulsion as a source of nutritional support. This form of nutritional support can help to preserve protein and …
Excerpt only. Read the full label for complete information.
About NDC 0990-7171
- What is NDC 0990-7171?
- 0990-7171 is the product NDC for Aminosyn II, Isoleucine 990 mg/100mL + 16 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 II (ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE).
- What is the active ingredient?
- Isoleucine, Leucine, Lysine acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic acid, Glutamic acid, Histidine, Proline, Serine, Acetyl l-tyrosine, Glycine.
- 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 II?
- 1 other product NDC are listed under this name. See all Aminosyn II NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Aminosyn II 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 IIisoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine | Isoleucine 660 mg/100mL + 16 more ingredients | Injection, SolutionIntravenous | ICU Medical Inc. | 0990-7172 | 00990-7172-17 |