NDC 0409-5921

Aminophylline

Aminophylline

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

Product ID0409-5921_1b02c692-43bd-44bb-af74-1b09cd7dbfcd
NDC0409-5921
Product TypeHuman Prescription Drug
Proprietary NameAminophylline
Generic NameAminophylline
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-06-24
Marketing CategoryANDA / ANDA
Application NumberANDA087242
Labeler NameHospira, Inc.
Substance NameAMINOPHYLLINE DIHYDRATE
Active Ingredient Strength25 mg/mL
Pharm ClassesMethylxanthine [EPC],Xanthines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0409-5921-01

25 VIAL, SINGLE-DOSE in 1 TRAY (0409-5921-01) > 10 mL in 1 VIAL, SINGLE-DOSE (0409-5921-16)
Marketing Start Date2005-05-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-5921-16 [00409592116]

Aminophylline INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA087242
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-10-22

NDC 0409-5921-01 [00409592101]

Aminophylline INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA087242
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-05-10

NDC 0409-5921-10 [00409592110]

Aminophylline INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA087242
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-06-24
Marketing End Date2018-07-01

NDC 0409-5921-09 [00409592109]

Aminophylline INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA087242
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-06-24
Marketing End Date2018-07-01

Drug Details

Active Ingredients

IngredientStrength
AMINOPHYLLINE DIHYDRATE25 mg/mL

OpenFDA Data

SPL SET ID:f6d3d076-fc15-4178-b159-4100fc39066e
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

    © 2022 FDA.report
    This site is not affiliated with or endorsed by the FDA.