premasol - sulfite-free (amino acid)

Generic: 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

Labeler: baxter healthcare company
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand 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
Labeler baxter healthcare company
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

alanine .54 g/100mL, arginine 1.2 g/100mL, aspartic acid .32 g/100mL, cysteine hydrochloride .016 g/100mL, glutamic acid .5 g/100mL, glycine .36 g/100mL, histidine .48 g/100mL, isoleucine .82 g/100mL, leucine 1.4 g/100mL, lysine acetate .82 g/100mL, methionine .34 g/100mL, phenylalanine .48 g/100mL, proline .68 g/100mL, serine .38 g/100mL, taurine 25 mg/100mL, threonine .42 g/100mL, tryptophan .2 g/100mL, tyrosine .24 g/100mL, valine .78 g/100mL

Manufacturer
Baxter Healthcare Company

Identifiers & Regulatory

Product NDC 0338-1130
Product ID 0338-1130_4083b5c8-ad5f-43f6-ab19-3c87acb2883f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075880
Listing Expiration 2026-12-31
Marketing Start 2003-06-19

Pharmacologic Class

Established (EPC)
amino acid [epc]
Chemical Structure
amino acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03381130
Hyphenated Format 0338-1130

Supplemental Identifiers

RxCUI
801395 801398 801403 801405
UNII
OF5P57N2ZX 94ZLA3W45F 30KYC7MIAI ZT934N0X4W 3KX376GY7L TE7660XO1C 4QD397987E 04Y7590D77 GMW67QNF9C TTL6G7LIWZ AE28F7PNPL 47E5O17Y3R 9DLQ4CIU6V 452VLY9402 1EQV5MLY3D 2ZD004190S 8DUH1N11BX 42HK56048U HG18B9YRS7
NUI
N0000175780 M0000922

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name premasol - sulfite-free (amino acid) (source: ndc)
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 (source: ndc)
Application Number ANDA075880 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .54 g/100mL
  • 1.2 g/100mL
  • .32 g/100mL
  • .016 g/100mL
  • .5 g/100mL
  • .36 g/100mL
  • .48 g/100mL
  • .82 g/100mL
  • 1.4 g/100mL
  • .34 g/100mL
  • .68 g/100mL
  • .38 g/100mL
  • 25 mg/100mL
  • .42 g/100mL
  • .2 g/100mL
  • .24 g/100mL
  • .78 g/100mL
source: ndc
Packaging
  • 500 mL in 1 BAG (0338-1130-03)
  • 1000 mL in 1 BAG (0338-1130-04)
  • 2000 mL in 1 BAG (0338-1130-06)
source: ndc

Packages (3)

0338-1130-03 500 mL in 1 BAG (0338-1130-03) 0338-1130-04 1000 mL in 1 BAG (0338-1130-04) 0338-1130-06 2000 mL in 1 BAG (0338-1130-06)

Ingredients (19)

alanine (.54 g/100mL) arginine (1.2 g/100mL) aspartic acid (.32 g/100mL) cysteine hydrochloride (.016 g/100mL) glutamic acid (.5 g/100mL) glycine (.36 g/100mL) histidine (.48 g/100mL) isoleucine (.82 g/100mL) leucine (1.4 g/100mL) lysine acetate (.82 g/100mL) methionine (.34 g/100mL) phenylalanine (.48 g/100mL) proline (.68 g/100mL) serine (.38 g/100mL) taurine (25 mg/100mL) threonine (.42 g/100mL) tryptophan (.2 g/100mL) tyrosine (.24 g/100mL) valine (.78 g/100mL)

Linked Drug Pages (1)

Premasol - sulfite-free (Amino Acid) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4083b5c8-ad5f-43f6-ab19-3c87acb2883f", "openfda": {"nui": ["N0000175780", "M0000922"], "unii": ["OF5P57N2ZX", "94ZLA3W45F", "30KYC7MIAI", "ZT934N0X4W", "3KX376GY7L", "TE7660XO1C", "4QD397987E", "04Y7590D77", "GMW67QNF9C", "TTL6G7LIWZ", "AE28F7PNPL", "47E5O17Y3R", "9DLQ4CIU6V", "452VLY9402", "1EQV5MLY3D", "2ZD004190S", "8DUH1N11BX", "42HK56048U", "HG18B9YRS7"], "rxcui": ["801395", "801398", "801403", "801405"], "spl_set_id": ["9afdcc3e-0d06-47f4-86ca-40da48b2b02b"], "pharm_class_cs": ["Amino Acids [CS]"], "pharm_class_epc": ["Amino Acid [EPC]"], "manufacturer_name": ["Baxter Healthcare Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BAG (0338-1130-03)", "package_ndc": "0338-1130-03", "marketing_start_date": "20030619"}, {"sample": false, "description": "1000 mL in 1 BAG (0338-1130-04)", "package_ndc": "0338-1130-04", "marketing_start_date": "20030619"}, {"sample": false, "description": "2000 mL in 1 BAG (0338-1130-06)", "package_ndc": "0338-1130-06", "marketing_start_date": "20030619"}], "brand_name": "Premasol - sulfite-free (Amino Acid)", "product_id": "0338-1130_4083b5c8-ad5f-43f6-ab19-3c87acb2883f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amino Acid [EPC]", "Amino Acids [CS]"], "product_ndc": "0338-1130", "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", "labeler_name": "Baxter Healthcare Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Premasol - sulfite-free (Amino Acid)", "active_ingredients": [{"name": "ALANINE", "strength": ".54 g/100mL"}, {"name": "ARGININE", "strength": "1.2 g/100mL"}, {"name": "ASPARTIC ACID", "strength": ".32 g/100mL"}, {"name": "CYSTEINE HYDROCHLORIDE", "strength": ".016 g/100mL"}, {"name": "GLUTAMIC ACID", "strength": ".5 g/100mL"}, {"name": "GLYCINE", "strength": ".36 g/100mL"}, {"name": "HISTIDINE", "strength": ".48 g/100mL"}, {"name": "ISOLEUCINE", "strength": ".82 g/100mL"}, {"name": "LEUCINE", "strength": "1.4 g/100mL"}, {"name": "LYSINE ACETATE", "strength": ".82 g/100mL"}, {"name": "METHIONINE", "strength": ".34 g/100mL"}, {"name": "PHENYLALANINE", "strength": ".48 g/100mL"}, {"name": "PROLINE", "strength": ".68 g/100mL"}, {"name": "SERINE", "strength": ".38 g/100mL"}, {"name": "TAURINE", "strength": "25 mg/100mL"}, {"name": "THREONINE", "strength": ".42 g/100mL"}, {"name": "TRYPTOPHAN", "strength": ".2 g/100mL"}, {"name": "TYROSINE", "strength": ".24 g/100mL"}, {"name": "VALINE", "strength": ".78 g/100mL"}], "application_number": "ANDA075880", "marketing_category": "ANDA", "marketing_start_date": "20030619", "listing_expiration_date": "20261231"}