NDC 50111-459

Theophylline

Theophylline

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

Product ID50111-459_7ead0af5-da03-4e84-8685-f469cfde4855
NDC50111-459
Product TypeHuman Prescription Drug
Proprietary NameTheophylline
Generic NameTheophylline
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2010-09-13
Marketing CategoryANDA / ANDA
Application NumberANDA089763
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameTHEOPHYLLINE ANHYDROUS
Active Ingredient Strength300 mg/1
Pharm ClassesMethylxanthine [EPC],Xanthines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50111-459-03

1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50111-459-03)
Marketing Start Date2010-09-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50111-459-03 [50111045903]

Theophylline TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089763
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-13
Marketing End Date2018-04-30

NDC 50111-459-02 [50111045902]

Theophylline TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089763
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-13
Marketing End Date2018-03-31

NDC 50111-459-01 [50111045901]

Theophylline TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089763
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-09-13
Marketing End Date2018-04-30

Drug Details

Active Ingredients

IngredientStrength
THEOPHYLLINE ANHYDROUS300 mg/1

OpenFDA Data

SPL SET ID:d70152c7-9da5-4096-ac5b-c8118cf48500
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 237178
  • 346574
  • 314241
  • 317769

    • Pharmacological Class

    • Methylxanthine [EPC]
    • Xanthines [CS]

    Medicade Reported Pricing

    50111045903 THEOPHYLLINE ER 300 MG TAB

    Pricing Unit: EA | Drug Type:

    50111045902 THEOPHYLLINE ER 300 MG TAB

    Pricing Unit: EA | Drug Type:

    50111045901 THEOPHYLLINE ER 300 MG TAB

    Pricing Unit: EA | Drug Type:

    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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