NDC Package 0338-1131-03 Premasol - Sulfite-free (amino Acid)

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0338-1131-03
Package Description:
500 mL in 1 BAG
Product Code:
Proprietary Name:
Premasol - Sulfite-free (amino Acid)
Usage Information:
6% and 10% PREMASOL - sulfite-free (Amino Acid) Injections are 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 - sulfite-free (Amino Acid) Injections 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, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance. See Dosage and Administration for additional information.
11-Digit NDC Billing Format:
00338113103
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
500 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 801395 - alanine 3.2 MG/ML / arginine 7.3 MG/ML / aspartate 1.9 MG/ML / cysteine 0.14 MG/ML / glutamate 3 MG/ML / glycine 2.2 MG/ML / histidine 2.9 MG/ML / isoleucine 4.9 MG/ML / leucine 8.4 MG/ML / lysine 4.9 MG/ML / methionine 2 MG/ML / phenylalanine 2.9 MG/ML / proline 4.1 MG/ML / serine 2.3 MG/ML / taurine 0.15 MG/ML / threonine 2.5 MG/ML / tryptophan 1.2 MG/ML / tyrosine 1.4 MG/ML / valine 4.7 MG/ML Injectable Solution
  • RxCUI: 801398 - PremaSol 6 % Injectable Solution
  • RxCUI: 801398 - alanine 3.2 MG/ML / arginine 7.3 MG/ML / aspartate 1.9 MG/ML / cysteine 0.14 MG/ML / glutamate 3 MG/ML / glycine 2.2 MG/ML / histidine 2.9 MG/ML / isoleucine 4.9 MG/ML / leucine 8.4 MG/ML / lysine 4.9 MG/ML / methionine 2 MG/ML / phenylalanine 2.9 MG/ML / proline 4.1 MG/ML / serine 2.3 MG/ML / taurine 0.15 MG/ML / threonine 2.5 MG/ML / tryptophan 1.2 MG/ML / tyrosine 1.4 MG/ML / valine 4.7 MG/ML Injectable Solution [PremaSol]
  • RxCUI: 801398 - PremaSol 6 % Amino Acids Injectable Solution
  • RxCUI: 801403 - alanine 5.4 MG/ML / arginine 12 MG/ML / aspartate 3.2 MG/ML / cysteine 0.16 MG/ML / glutamate 5 MG/ML / glycine 3.6 MG/ML / histidine 4.8 MG/ML / isoleucine 8.2 MG/ML / leucine 14 MG/ML / lysine 8.2 MG/ML / methionine 3.4 MG/ML / phenylalanine 4.8 MG/ML / proline 6.8 MG/ML / serine 3.8 MG/ML / taurine 0.25 MG/ML / threonine 4.2 MG/ML / tryptophan 2 MG/ML / tyrosine 2.4 MG/ML / valine 7.8 MG/ML Injectable Solution
Labeler Name:
Baxter Healthcare Company
Sample Package:
No
FDA Application Number:
ANDA075880
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-19-2003
End Marketing Date:
01-31-2020
Listing Expiration Date:
01-31-2020
Exclude Flag:
D

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 NDC 0338-1131-03?

The NDC Packaged Code 0338-1131-03 is assigned to a package of 500 ml in 1 bag of Premasol - Sulfite-free (amino Acid), labeled by Baxter Healthcare Company. The product's dosage form is and is administered via form.This product is billed per "ML" milliliter and contains an estimated amount of 500 billable units per package.

Is NDC 0338-1131 included in the NDC Directory?

No, Premasol - Sulfite-free (amino Acid) with product code 0338-1131 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Baxter Healthcare Company on June 19, 2003 and its listing in the NDC Directory is set to expire on January 31, 2020 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0338-1131-03?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 500.

What is the 11-digit format for NDC 0338-1131-03?

The 11-digit format is 00338113103. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20338-1131-035-4-200338-1131-03