NDC 52584-921

Aminophylline

Aminophylline

Aminophylline is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Aminophylline Dihydrate.

Product ID52584-921_1abfe717-6b19-46a3-90d1-3ec1e2ee1346
NDC52584-921
Product TypeHuman Prescription Drug
Proprietary NameAminophylline
Generic NameAminophylline
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA087242
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NameAMINOPHYLLINE DIHYDRATE
Active Ingredient Strength25 mg/mL
Pharm ClassesMethylxanthine [EPC],Xanthines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52584-921-01

1 VIAL, SINGLE-DOSE in 1 BAG (52584-921-01) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2010-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-921-01 [52584092101]

Aminophylline INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA087242
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-07-01

Drug Details

Active Ingredients

IngredientStrength
AMINOPHYLLINE DIHYDRATE25 mg/mL

OpenFDA Data

SPL SET ID:f775d030-4a1a-4639-8de2-a4191c727900
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1724668
  • Pharmacological Class

    • Methylxanthine [EPC]
    • Xanthines [CS]

    NDC Crossover Matching brand name "Aminophylline" or generic name "Aminophylline"

    NDCBrand NameGeneric Name
    0404-9813AminophyllineAminophylline
    0404-9814AminophyllineAminophylline
    0409-5921AminophyllineAminophylline
    0409-5922AminophyllineAminophylline
    51662-1204AMINOPHYLLINEAMINOPHYLLINE
    51662-1341AMINOPHYLLINEAMINOPHYLLINE
    52584-921AminophyllineAminophylline
    52584-922AminophyllineAminophylline
    55154-2366AminophyllineAminophylline Dihydrate
    55154-6987AminophyllineAminophylline Dihydrate
    71872-7060AminophyllineAminophylline
    71872-7121AminophyllineAminophylline

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