NDC 29033-001

Theophylline (Anhydrous)

Theophylline

Theophylline (Anhydrous) is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Nostrum Laboratories, Inc.. The primary component is Theophylline Anhydrous.

Product ID29033-001_46075998-bf04-4f36-aa34-7227952c408d
NDC29033-001
Product TypeHuman Prescription Drug
Proprietary NameTheophylline (Anhydrous)
Generic NameTheophylline
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-01-23
Marketing CategoryANDA / ANDA
Application NumberANDA040560
Labeler NameNostrum Laboratories, Inc.
Substance NameTHEOPHYLLINE ANHYDROUS
Active Ingredient Strength400 mg/1
Pharm ClassesMethylxanthine [EPC],Xanthines [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 29033-001-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29033-001-01)
Marketing Start Date2020-01-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 29033-001-01 [29033000101]

Theophylline (Anhydrous) TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040560
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-23

NDC 29033-001-05 [29033000105]

Theophylline (Anhydrous) TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040560
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-06-01
Marketing End Date2018-03-05

Drug Details

Active Ingredients

IngredientStrength
THEOPHYLLINE ANHYDROUS400 mg/1

OpenFDA Data

SPL SET ID:038c2b07-8028-4dc4-847c-adafe1b0e81a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 348472
  • 313291
  • UPC Code
  • 0329033002011
  • 0329033001014
  • Pharmacological Class

    • Methylxanthine [EPC]
    • Xanthines [CS]

    Medicade Reported Pricing

    29033001912 CARBAMAZEPINE ER 100 MG CAP

    Pricing Unit: EA | Drug Type:

    29033001810 METFORMIN HCL ER 500 MG TABLET

    Pricing Unit: EA | Drug Type:

    29033001805 METFORMIN HCL ER 500 MG TABLET

    Pricing Unit: EA | Drug Type:

    29033001801 METFORMIN HCL ER 500 MG TABLET

    Pricing Unit: EA | Drug Type:

    29033001305 PIROXICAM 20 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    29033001301 PIROXICAM 20 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    29033001201 PIROXICAM 10 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    29033000101 THEOPHYLLINE ER 400 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    68151-4210Theophylline (Anhydrous)Theophylline (Anhydrous)
    53808-0316Theophylline (Anhydrous)Theophylline (Anhydrous)
    53808-0315Theophylline (Anhydrous)Theophylline (Anhydrous)
    51407-319Theophylline (Anhydrous)Theophylline (Anhydrous)
    0121-0820THEOPHYLLINETHEOPHYLLINE
    0121-4820THEOPHYLLINETHEOPHYLLINE
    0378-0486TheophyllineTheophylline
    0378-0487TheophyllineTheophylline
    0480-3309TheophyllineTheophylline
    0480-3310TheophyllineTheophylline
    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
    51407-318TheophyllineTheophylline
    16571-011Theophylline(Anhydrous)Theophylline

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