prosol

Generic: valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name prosol
Generic Name valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine
Labeler baxter healthcare corporation
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

alanine 2.76 g/100mL, arginine 1.96 g/100mL, aspartic acid 600 mg/100mL, glutamic acid 1.02 g/100mL, glycine 2.06 g/100mL, histidine 1.18 g/100mL, isoleucine 1.08 g/100mL, leucine 1.08 g/100mL, lysine acetate 1.35 g/100mL, methionine 760 mg/100mL, phenylalanine 1 g/100mL, proline 1.34 g/100mL, serine 1.02 g/100mL, threonine 980 mg/100mL, tryptophan 320 mg/100mL, tyrosine 50 mg/100mL, valine 1.44 g/100mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-0499
Product ID 0338-0499_ee240b46-c2a9-42e0-8750-a5a554becea3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020849
Listing Expiration 2026-12-31
Marketing Start 1998-08-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03380499
Hyphenated Format 0338-0499

Supplemental Identifiers

RxCUI
801133 801136
UNII
OF5P57N2ZX 94ZLA3W45F 30KYC7MIAI 3KX376GY7L TE7660XO1C 4QD397987E 04Y7590D77 GMW67QNF9C TTL6G7LIWZ AE28F7PNPL 47E5O17Y3R 9DLQ4CIU6V 452VLY9402 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 prosol (source: ndc)
Generic Name valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine (source: ndc)
Application Number NDA020849 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2.76 g/100mL
  • 1.96 g/100mL
  • 600 mg/100mL
  • 1.02 g/100mL
  • 2.06 g/100mL
  • 1.18 g/100mL
  • 1.08 g/100mL
  • 1.35 g/100mL
  • 760 mg/100mL
  • 1 g/100mL
  • 1.34 g/100mL
  • 980 mg/100mL
  • 320 mg/100mL
  • 50 mg/100mL
  • 1.44 g/100mL
source: ndc
Packaging
  • 2000 mL in 1 BAG (0338-0499-06)
source: ndc

Packages (1)

0338-0499-06 2000 mL in 1 BAG (0338-0499-06)

Ingredients (17)

alanine (2.76 g/100mL) arginine (1.96 g/100mL) aspartic acid (600 mg/100mL) glutamic acid (1.02 g/100mL) glycine (2.06 g/100mL) histidine (1.18 g/100mL) isoleucine (1.08 g/100mL) leucine (1.08 g/100mL) lysine acetate (1.35 g/100mL) methionine (760 mg/100mL) phenylalanine (1 g/100mL) proline (1.34 g/100mL) serine (1.02 g/100mL) threonine (980 mg/100mL) tryptophan (320 mg/100mL) tyrosine (50 mg/100mL) valine (1.44 g/100mL)

Linked Drug Pages (1)

ProSol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ee240b46-c2a9-42e0-8750-a5a554becea3", "openfda": {"nui": ["N0000175780", "M0000922"], "unii": ["OF5P57N2ZX", "94ZLA3W45F", "30KYC7MIAI", "3KX376GY7L", "TE7660XO1C", "4QD397987E", "04Y7590D77", "GMW67QNF9C", "TTL6G7LIWZ", "AE28F7PNPL", "47E5O17Y3R", "9DLQ4CIU6V", "452VLY9402", "2ZD004190S", "8DUH1N11BX", "42HK56048U", "HG18B9YRS7"], "rxcui": ["801133", "801136"], "spl_set_id": ["cc2ace81-5881-43f1-ba94-41b674adc2fc"], "pharm_class_cs": ["Amino Acids [CS]"], "pharm_class_epc": ["Amino Acid [EPC]"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2000 mL in 1 BAG (0338-0499-06)", "package_ndc": "0338-0499-06", "marketing_start_date": "19980826"}], "brand_name": "ProSol", "product_id": "0338-0499_ee240b46-c2a9-42e0-8750-a5a554becea3", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amino Acid [EPC]", "Amino Acids [CS]"], "product_ndc": "0338-0499", "generic_name": "Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and Tyrosine", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ProSol", "active_ingredients": [{"name": "ALANINE", "strength": "2.76 g/100mL"}, {"name": "ARGININE", "strength": "1.96 g/100mL"}, {"name": "ASPARTIC ACID", "strength": "600 mg/100mL"}, {"name": "GLUTAMIC ACID", "strength": "1.02 g/100mL"}, {"name": "GLYCINE", "strength": "2.06 g/100mL"}, {"name": "HISTIDINE", "strength": "1.18 g/100mL"}, {"name": "ISOLEUCINE", "strength": "1.08 g/100mL"}, {"name": "LEUCINE", "strength": "1.08 g/100mL"}, {"name": "LYSINE ACETATE", "strength": "1.35 g/100mL"}, {"name": "METHIONINE", "strength": "760 mg/100mL"}, {"name": "PHENYLALANINE", "strength": "1 g/100mL"}, {"name": "PROLINE", "strength": "1.34 g/100mL"}, {"name": "SERINE", "strength": "1.02 g/100mL"}, {"name": "THREONINE", "strength": "980 mg/100mL"}, {"name": "TRYPTOPHAN", "strength": "320 mg/100mL"}, {"name": "TYROSINE", "strength": "50 mg/100mL"}, {"name": "VALINE", "strength": "1.44 g/100mL"}], "application_number": "NDA020849", "marketing_category": "NDA", "marketing_start_date": "19980826", "listing_expiration_date": "20261231"}