NDC 0264-9554

Theophylline in Dextrose

Theophylline Anhydrous And Dextrose

Theophylline in Dextrose is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by B. Braun Medical Inc.. The primary component is Theophylline Anhydrous; Dextrose Monohydrate.

Product ID0264-9554_5df8f4d8-1afb-48e9-9175-768cf77c3064
NDC0264-9554
Product TypeHuman Prescription Drug
Proprietary NameTheophylline in Dextrose
Generic NameTheophylline Anhydrous And Dextrose
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1992-08-14
Marketing CategoryNDA / NDA
Application NumberNDA019826
Labeler NameB. Braun Medical Inc.
Substance NameTHEOPHYLLINE ANHYDROUS; DEXTROSE MONOHYDRATE
Active Ingredient Strength80 mg/100mL; g/100mL
Pharm ClassesMethylxanthine [EPC],Xanthines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0264-9554-10

24 CONTAINER in 1 CASE (0264-9554-10) > 500 mL in 1 CONTAINER
Marketing Start Date1992-08-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0264-9554-10 [00264955410]

Theophylline in Dextrose INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019826
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1992-08-14

NDC 0264-9554-00 [00264955400]

Theophylline in Dextrose INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019826
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1992-08-14
Marketing End Date2011-09-21

Drug Details

Active Ingredients

IngredientStrength
THEOPHYLLINE ANHYDROUS80 mg/100mL

OpenFDA Data

SPL SET ID:c3bb34c1-89b2-48c3-9ad2-16b4b2bce5f9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313263
  • Pharmacological Class

    • Methylxanthine [EPC]
    • Xanthines [CS]
    • Methylxanthine [EPC]
    • Xanthines [CS]

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