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NDC 00338-1130-03 Premasol - sulfite-free (Amino Acid) .54; 1.2; .32; .016; .5; .36; .48; .82; 1.4; .82; .34; .48; .68; .38; 25; .42; .2; .24; .78 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; g/100mL Details
Premasol - sulfite-free (Amino Acid) .54; 1.2; .32; .016; .5; .36; .48; .82; 1.4; .82; .34; .48; .68; .38; 25; .42; .2; .24; .78 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; g/100mL
Premasol - sulfite-free (Amino Acid) is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is ALANINE; ARGININE; ASPARTIC ACID; CYSTEINE HYDROCHLORIDE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE.
Product Information
| NDC | 00338-1130 |
|---|---|
| Product ID | 0338-1130_15389cc5-b934-41cf-81c6-b84a04b15f80 |
| Associated GPIs | 80302010102040 |
| GCN Sequence Number | 063539 |
| GCN Sequence Number Description | parenteral amino acid 10% no.7 IV SOLN 10 % INTRAVEN |
| HIC3 | C9C |
| HIC3 Description | PARENTERAL AMINO ACID SOLUTIONS AND COMBINATIONS |
| GCN | 99261 |
| HICL Sequence Number | 035297 |
| HICL Sequence Number Description | PARENTERAL AMINO ACID 10% COMBINATION NO.7 |
| Brand/Generic | Brand |
| Proprietary Name | Premasol - sulfite-free (Amino Acid) |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | .54; 1.2; .32; .016; .5; .36; .48; .82; 1.4; .82; .34; .48; .68; .38; 25; .42; .2; .24; .78 |
| Active Ingredient Units | g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; g/100mL |
| Substance Name | ALANINE; ARGININE; ASPARTIC ACID; CYSTEINE HYDROCHLORIDE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
| Labeler Name | Baxter Healthcare Corporation |
| Pharmaceutical Class | Amino Acid [EPC], Amino Acids [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075880 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00338-1130-03 (00338113003)
| NDC Package Code | 0338-1130-03 |
|---|---|
| Billing NDC | 00338113003 |
| Package | 500 mL in 1 BAG (0338-1130-03) |
| Marketing Start Date | 2003-06-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |