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 Leucine; Lysine Acetate; Isoleucine; Valine; Histidine; Phenylalanine; Threonine; Methionine; Tryptophan; Tyrosine; Arginine; Proline; Alanine; Glutamic Acid; Serine; Glycine; Aspartic Acid; Taurine; Cysteine Hydrochloride.
Product ID | 0338-1130_49eb2f11-79ad-47ec-8c8f-7ebbf0490285 |
NDC | 0338-1130 |
Product Type | Human Prescription Drug |
Proprietary Name | Premasol - sulfite-free (Amino Acid) |
Generic 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 |
Dosage Form | Injection, Solution |
Route of Administration | INTRAVENOUS |
Marketing Start Date | 2003-06-19 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA075880 |
Labeler Name | Baxter Healthcare Corporation |
Substance Name | LEUCINE; LYSINE ACETATE; ISOLEUCINE; VALINE; HISTIDINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; TYROSINE; ARGININE; PROLINE; ALANINE; GLUTAMIC ACID; SERINE; GLYCINE; ASPARTIC ACID; TAURINE; CYSTEINE HYDROCHLORIDE |
Active Ingredient Strength | 1 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; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL |
Pharm Classes | Amino Acid [EPC],Amino Acids [CS] |
NDC Exclude Flag | N |
Listing Certified Through | 2022-12-31 |
Marketing Start Date | 2003-06-19 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA075880 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2003-06-19 |
Marketing Category | ANDA |
Application Number | ANDA075880 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2003-06-19 |
Marketing Category | ANDA |
Application Number | ANDA075880 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2003-06-19 |
Ingredient | Strength |
---|---|
LEUCINE | 1.4 g/100mL |
SPL SET ID: | 9afdcc3e-0d06-47f4-86ca-40da48b2b02b |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
0338-1130 | Premasol - sulfite-free (Amino Acid) | 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 |
0338-1131 | Premasol - sulfite-free (Amino Acid) | 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 |