NDC 0338-0502

Clinisol

Lysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, Tyrosine

Clinisol is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Lysine Acetate; Leucine; Phenylalanine; Valine; Histidine; Isoleucine; Methionine; Threonine; Tryptophan; Alanine; Arginine; Glycine; Proline; Glutamic Acid; Serine; Aspartic Acid; Tyrosine.

Product ID0338-0502_285c0c47-67bf-46bd-a244-b9b9b7927318
NDC0338-0502
Product TypeHuman Prescription Drug
Proprietary NameClinisol
Generic NameLysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, Tyrosine
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1996-08-30
Marketing CategoryANDA / ANDA
Application NumberANDA020512
Labeler NameBaxter Healthcare Corporation
Substance NameLYSINE ACETATE; LEUCINE; PHENYLALANINE; VALINE; HISTIDINE; ISOLEUCINE; METHIONINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE
Active Ingredient Strength1 g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharm ClassesAmino Acid [EPC],Amino Acids [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0338-0502-03

500 mL in 1 BAG (0338-0502-03)
Marketing Start Date1996-08-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0338-0502-03 [00338050203]

Clinisol INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA020512
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1996-08-30

NDC 0338-0502-06 [00338050206]

Clinisol INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA020512
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1996-08-30

Drug Details

Active Ingredients

IngredientStrength
LYSINE ACETATE1.18 g/100mL

OpenFDA Data

SPL SET ID:65ffc962-7538-41ea-9afb-4af5fbce4c5b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 800588
  • 800584
  • Pharmacological Class

    • Amino Acid [EPC]
    • Amino Acids [CS]

    Trademark Results [Clinisol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CLINISOL
    CLINISOL
    75028982 2127661 Live/Registered
    BAXTER INTERNATIONAL, INC.
    1995-12-07

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.