NDC 63629-7169

Theophylline Anhydrous

Theophylline

Theophylline Anhydrous is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Theophylline Anhydrous.

Product ID63629-7169_de3f4cd3-b125-4e34-917d-1e1bd35fff98
NDC63629-7169
Product TypeHuman Prescription Drug
Proprietary NameTheophylline Anhydrous
Generic NameTheophylline
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-02-02
Marketing CategoryANDA / ANDA
Application NumberANDA087571
Labeler NameBryant Ranch Prepack
Substance NameTHEOPHYLLINE ANHYDROUS
Active Ingredient Strength400 mg/1
Pharm ClassesMethylxanthine [EPC],Xanthines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63629-7169-1

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7169-1)
Marketing Start Date2016-12-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-7169-1 [63629716901]

Theophylline Anhydrous TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA087571
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
THEOPHYLLINE ANHYDROUS400 mg/1

OpenFDA Data

SPL SET ID:d7fff827-366c-4a34-bc94-f443f9451c7d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313291
  • Pharmacological Class

    • Methylxanthine [EPC]
    • Xanthines [CS]

    NDC Crossover Matching brand name "Theophylline Anhydrous" or generic name "Theophylline"

    NDCBrand NameGeneric Name
    68151-0667Theophylline AnhydrousTheophylline Anhydrous
    63629-7169Theophylline AnhydrousTheophylline Anhydrous
    17856-0644ELIXOPHYLLINTHEOPHYLLINE ANHYDROUS
    49708-644ELIXOPHYLLINTHEOPHYLLINE ANHYDROUS
    0121-0820THEOPHYLLINETHEOPHYLLINE
    0121-4794TheophyllineTHEOPHYLLINE ANHYDROUS
    0121-4820THEOPHYLLINETHEOPHYLLINE
    0378-0486TheophyllineTheophylline
    0378-0487TheophyllineTheophylline
    0480-3309TheophyllineTheophylline
    0480-3310TheophyllineTheophylline
    10135-604TheophyllineTheophylline Anhydrous
    17856-0038TheophyllineTheophylline
    23155-741TheophyllineTheophylline
    23155-742TheophyllineTheophylline
    27808-033TheophyllineTheophylline
    29033-001TheophyllineTheophylline
    29033-002TheophyllineTheophylline
    42858-701TheophyllineTheophylline
    42858-702TheophyllineTheophylline
    46708-025TheophyllineTheophylline
    46708-026TheophyllineTheophylline
    50111-459TheophyllineTheophylline
    50111-482TheophyllineTheophylline
    16571-011Theophylline(Anhydrous)Theophylline

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