NDC 46708-026

Theophylline

Theophylline

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

Product ID46708-026_059f65c6-e5fa-4c07-bebb-b24403753e2e
NDC46708-026
Product TypeHuman Prescription Drug
Proprietary NameTheophylline
Generic NameTheophylline
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2010-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA090430
Labeler NameAlembic Pharmaceuticals Limited
Substance NameTHEOPHYLLINE ANHYDROUS
Active Ingredient Strength450 mg/1
Pharm ClassesMethylxanthine [EPC],Xanthines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 46708-026-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-026-30)
Marketing Start Date2010-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-026-71 [46708002671]

Theophylline TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090430
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-01

NDC 46708-026-31 [46708002631]

Theophylline TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090430
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-01

NDC 46708-026-30 [46708002630]

Theophylline TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090430
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-11-01

Drug Details

Active Ingredients

IngredientStrength
THEOPHYLLINE ANHYDROUS450 mg/1

OpenFDA Data

SPL SET ID:31f3c720-1597-4d43-9296-33017b90b15f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314241
  • 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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