NDC 0338-0499

ProSol

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

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

Product ID0338-0499_30e4effd-be24-4f3a-a225-3e681ef72e7d
NDC0338-0499
Product TypeHuman Prescription Drug
Proprietary NameProSol
Generic NameValine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid And Tyrosine
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1998-08-26
Marketing CategoryNDA / NDA
Application NumberNDA020849
Labeler NameBaxter Healthcare Corporation
Substance NameVALINE; LYSINE ACETATE; HISTIDINE; ISOLEUCINE; LEUCINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE
Active Ingredient Strength1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL
Pharm ClassesAmino Acid [EPC],Amino Acids [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0338-0499-06

2000 mL in 1 BAG (0338-0499-06)
Marketing Start Date1998-08-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0338-0499-06 [00338049906]

ProSol INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020849
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1998-08-26

NDC 0338-0499-03 [00338049903]

ProSol INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020849
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-08-26
Marketing End Date2018-11-09

NDC 0338-0499-04 [00338049904]

ProSol INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020849
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1998-08-26
Marketing End Date2018-11-09

Drug Details

Active Ingredients

IngredientStrength
VALINE1.44 g/100mL

OpenFDA Data

SPL SET ID:cc2ace81-5881-43f1-ba94-41b674adc2fc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 801133
  • 801136

    • Pharmacological Class

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

    Trademark Results [ProSol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROSOL
    PROSOL
    98394544 not registered Live/Pending
    KUHONG (USA) COMPANY
    2024-02-06
    PROSOL
    PROSOL
    85395304 4519865 Live/Registered
    Schüco International KG
    2011-08-11
    PROSOL
    PROSOL
    75665934 2326368 Dead/Cancelled
    NEW JERSEY LABORATORIES
    1999-03-22
    PROSOL
    PROSOL
    75645527 2470231 Dead/Cancelled
    Pfaudler, Inc.
    1999-02-22
    PROSOL
    PROSOL
    75337109 not registered Dead/Abandoned
    PACIFICHEALTH LABORATORIES, INC.
    1997-08-07
    PROSOL
    PROSOL
    75202056 2112350 Dead/Cancelled
    Process Solutions, Inc.
    1996-11-20
    PROSOL
    PROSOL
    75082977 2362487 Live/Registered
    BAXTER INTERNATIONAL INC.
    1996-04-02
    PROSOL
    PROSOL
    73835753 1645775 Dead/Cancelled
    DENTSPLY INTERNATIONAL INC.
    1989-11-03
    PROSOL
    PROSOL
    73548128 1406418 Dead/Cancelled
    N.V. NUTRICIA
    1985-07-15
    PROSOL
    PROSOL
    72444988 0973242 Dead/Expired
    MOBIL OIL CORPORATION
    1973-01-02
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