NDC 63629-5198

Theophylline

Theophylline

Theophylline 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 ID63629-5198_0a26ba42-6b96-467d-ab38-4b35988184f3
NDC63629-5198
Product TypeHuman Prescription Drug
Proprietary NameTheophylline
Generic NameTheophylline
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date1990-09-30
Marketing CategoryANDA / ANDA
Application NumberANDA089763
Labeler NameBryant Ranch Prepack
Substance NameTHEOPHYLLINE ANHYDROUS
Active Ingredient Strength300 mg/1
Pharm ClassesMethylxanthine [EPC],Xanthines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63629-5198-1

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-5198-1)
Marketing Start Date2014-01-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-5198-2 [63629519802]

Theophylline TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089763
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-09
Inactivation Date2020-01-31

NDC 63629-5198-1 [63629519801]

Theophylline TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089763
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-09
Inactivation Date2020-01-31

NDC 63629-5198-3 [63629519803]

Theophylline TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089763
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-09
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
THEOPHYLLINE ANHYDROUS300 mg/1

OpenFDA Data

SPL SET ID:e58491b5-b7de-4497-ab7a-d6c12972e744
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 317769

    • Pharmacological Class

    • Methylxanthine [EPC]
    • Xanthines [CS]

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

    NDCBrand NameGeneric Name
    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
    50111-483TheophyllineTheophylline
    50111-518TheophyllineTheophylline
    68151-1393TheophyllineTheophylline
    68462-380TheophyllineTheophylline
    68462-356TheophyllineTheophylline
    68788-0453TheophyllineTheophylline
    53808-0982TheophyllineTheophylline
    54838-556TheophyllineTheophylline
    60621-033TheophyllineTheophylline
    60687-258TheophyllineTheophylline
    62332-026TheophyllineTheophylline
    62332-025TheophyllineTheophylline
    63629-5198TheophyllineTheophylline
    63629-2792TheophyllineTheophylline
    16571-011Theophylline(Anhydrous)Theophylline
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