clinisol

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

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

Drug Facts

Product Profile

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

alanine 2.17 g/100mL, arginine 1.47 g/100mL, aspartic acid 434 mg/100mL, glutamic acid 749 mg/100mL, glycine 1.04 g/100mL, histidine 894 mg/100mL, isoleucine 749 mg/100mL, leucine 1.04 g/100mL, lysine acetate 1.18 g/100mL, methionine 749 mg/100mL, phenylalanine 1.04 g/100mL, proline 894 mg/100mL, serine 592 mg/100mL, threonine 749 mg/100mL, tryptophan 250 mg/100mL, tyrosine 39 mg/100mL, valine 960 mg/100mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-0502
Product ID 0338-0502_7eab93b5-5590-4381-8674-113a05edeff0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA020512
Listing Expiration 2026-12-31
Marketing Start 1996-08-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03380502
Hyphenated Format 0338-0502

Supplemental Identifiers

RxCUI
800584 800588
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 clinisol (source: ndc)
Generic Name lysine, leucine, phenylalanine, valine, histidine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, proline, glutamic acid, serine, aspartic acid, tyrosine (source: ndc)
Application Number ANDA020512 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2.17 g/100mL
  • 1.47 g/100mL
  • 434 mg/100mL
  • 749 mg/100mL
  • 1.04 g/100mL
  • 894 mg/100mL
  • 1.18 g/100mL
  • 592 mg/100mL
  • 250 mg/100mL
  • 39 mg/100mL
  • 960 mg/100mL
source: ndc
Packaging
  • 500 mL in 1 BAG (0338-0502-03)
  • 2000 mL in 1 BAG (0338-0502-06)
source: ndc

Packages (2)

0338-0502-03 500 mL in 1 BAG (0338-0502-03) 0338-0502-06 2000 mL in 1 BAG (0338-0502-06)

Ingredients (17)

alanine (2.17 g/100mL) arginine (1.47 g/100mL) aspartic acid (434 mg/100mL) glutamic acid (749 mg/100mL) glycine (1.04 g/100mL) histidine (894 mg/100mL) isoleucine (749 mg/100mL) leucine (1.04 g/100mL) lysine acetate (1.18 g/100mL) methionine (749 mg/100mL) phenylalanine (1.04 g/100mL) proline (894 mg/100mL) serine (592 mg/100mL) threonine (749 mg/100mL) tryptophan (250 mg/100mL) tyrosine (39 mg/100mL) valine (960 mg/100mL)

Linked Drug Pages (1)

Clinisol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7eab93b5-5590-4381-8674-113a05edeff0", "openfda": {"nui": ["N0000175780", "M0000922"], "unii": ["OF5P57N2ZX", "94ZLA3W45F", "30KYC7MIAI", "3KX376GY7L", "TE7660XO1C", "4QD397987E", "04Y7590D77", "GMW67QNF9C", "TTL6G7LIWZ", "AE28F7PNPL", "47E5O17Y3R", "9DLQ4CIU6V", "452VLY9402", "2ZD004190S", "8DUH1N11BX", "42HK56048U", "HG18B9YRS7"], "rxcui": ["800584", "800588"], "spl_set_id": ["65ffc962-7538-41ea-9afb-4af5fbce4c5b"], "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": "500 mL in 1 BAG (0338-0502-03)", "package_ndc": "0338-0502-03", "marketing_start_date": "19960830"}, {"sample": false, "description": "2000 mL in 1 BAG (0338-0502-06)", "package_ndc": "0338-0502-06", "marketing_start_date": "19960830"}], "brand_name": "Clinisol", "product_id": "0338-0502_7eab93b5-5590-4381-8674-113a05edeff0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amino Acid [EPC]", "Amino Acids [CS]"], "product_ndc": "0338-0502", "generic_name": "Lysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, Tyrosine", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clinisol", "active_ingredients": [{"name": "ALANINE", "strength": "2.17 g/100mL"}, {"name": "ARGININE", "strength": "1.47 g/100mL"}, {"name": "ASPARTIC ACID", "strength": "434 mg/100mL"}, {"name": "GLUTAMIC ACID", "strength": "749 mg/100mL"}, {"name": "GLYCINE", "strength": "1.04 g/100mL"}, {"name": "HISTIDINE", "strength": "894 mg/100mL"}, {"name": "ISOLEUCINE", "strength": "749 mg/100mL"}, {"name": "LEUCINE", "strength": "1.04 g/100mL"}, {"name": "LYSINE ACETATE", "strength": "1.18 g/100mL"}, {"name": "METHIONINE", "strength": "749 mg/100mL"}, {"name": "PHENYLALANINE", "strength": "1.04 g/100mL"}, {"name": "PROLINE", "strength": "894 mg/100mL"}, {"name": "SERINE", "strength": "592 mg/100mL"}, {"name": "THREONINE", "strength": "749 mg/100mL"}, {"name": "TRYPTOPHAN", "strength": "250 mg/100mL"}, {"name": "TYROSINE", "strength": "39 mg/100mL"}, {"name": "VALINE", "strength": "960 mg/100mL"}], "application_number": "ANDA020512", "marketing_category": "ANDA", "marketing_start_date": "19960830", "listing_expiration_date": "20261231"}