Aminosyn Ii Injection, Solution
NDC Package 0990-7171-17
Package Information
Aminosyn Ii (isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine) injection is 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. This formulation utilizes a injection, solution delivery system. Marketed by Icu Medical Inc., this product is identified by NDC 0990-7171 and is authorized under FDA application NDA020041.
Identification & Billing
- RxCUI: 800188 - alanine 14.9 MG/ML / arginine 15.3 MG/ML / aspartate 10.5 MG/ML / glutamate 11.1 MG/ML / glycine 7.5 MG/ML / histidine 4.5 MG/ML / isoleucine 9.9 MG/ML / leucine 15 MG/ML / lysine 15.8 MG/ML / methionine 2.58 MG/ML / phenylalanine 4.47 MG/ML / proline 10.8 MG/ML / serine 7.95 MG/ML / threonine 6 MG/ML / tryptophan 3 MG/ML / tyrosine 4.05 MG/ML / valine 7.5 MG/ML Injectable Solution
- RxCUI: 800192 - Aminosyn II 15 % Injectable Solution
- RxCUI: 800192 - alanine 14.9 MG/ML / arginine 15.3 MG/ML / aspartate 10.5 MG/ML / glutamate 11.1 MG/ML / glycine 7.5 MG/ML / histidine 4.5 MG/ML / isoleucine 9.9 MG/ML / leucine 15 MG/ML / lysine 15.8 MG/ML / methionine 2.58 MG/ML / phenylalanine 4.47 MG/ML / proline 10.8 MG/ML / serine 7.95 MG/ML / threonine 6 MG/ML / tryptophan 3 MG/ML / tyrosine 4.05 MG/ML / valine 7.5 MG/ML Injectable Solution [Aminosyn II 15%]
- RxCUI: 800237 - alanine 9.93 MG/ML / arginine 10.2 MG/ML / aspartate 7 MG/ML / glutamate 7.38 MG/ML / glycine 5 MG/ML / histidine 3 MG/ML / isoleucine 6.6 MG/ML / leucine 10 MG/ML / lysine 10.5 MG/ML / methionine 1.72 MG/ML / phenylalanine 2.98 MG/ML / proline 7.22 MG/ML / serine 5.3 MG/ML / threonine 4 MG/ML / tryptophan 2 MG/ML / tyrosine 2.7 MG/ML / valine 5 MG/ML Injectable Solution
- RxCUI: 800241 - Aminosyn II 10 % Injectable Solution
Clinical Specifications
- ACETYL L-TYROSINE 405 mg/100mL
- ALANINE 1490 mg/100mL
- ARGININE 1527 mg/100mL
- ASPARTIC ACID 1050 mg/100mL
- GLUTAMIC ACID 1107 mg/100mL
- GLYCINE 750 mg/100mL
- HISTIDINE 450 mg/100mL
- ISOLEUCINE 990 mg/100mL
- LEUCINE 1500 mg/100mL
- LYSINE ACETATE 1575 mg/100mL
- METHIONINE 258 mg/100mL
- PHENYLALANINE 447 mg/100mL
- PROLINE 1083 mg/100mL
- SERINE 795 mg/100mL
- THREONINE 600 mg/100mL
- TRYPTOPHAN 300 mg/100mL
- VALINE 750 mg/100mL
Regulatory & Marketing
Hierarchy Structure
- 0990 - Icu Medical Inc.
- 0990-7171 - Aminosyn Ii
- 0990-7171-17 - 6 POUCH in 1 CASE / 1 BAG in 1 POUCH / 2000 mL in 1 BAG
- 0990-7171 - Aminosyn Ii
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0990-7171-17 identifies a specific commercial package of 6 pouch in 1 case / 1 bag in 1 pouch / 2000 ml in 1 bag of Aminosyn Ii, a human prescription drug labeled by Icu Medical Inc.. This injection, solution is formulated for intravenous use and contains acetyl l-tyrosine; alanine; arginine; aspartic acid; glutamic acid; glycine; histidine; isoleucine; leucine; lysine acetate; methionine; phenylalanine; proline; serine; threonine; tryptophan; valine as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Icu Medical Inc. on November 01, 2019. The current certification is valid through December 31, 2027.
How is this Icu Medical Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00990717117. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.