NDC 52244-400

Theo-24

Theophylline Anhydrous

Theo-24 is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Endo Pharmaceuticals, Inc.. The primary component is Theophylline Anhydrous.

Product ID52244-400_3d3b5bb2-53fa-44bc-b3ce-321158492d00
NDC52244-400
Product TypeHuman Prescription Drug
Proprietary NameTheo-24
Generic NameTheophylline Anhydrous
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-08-25
Marketing CategoryANDA / ANDA
Application NumberANDA081034
Labeler NameEndo Pharmaceuticals, Inc.
Substance NameTHEOPHYLLINE ANHYDROUS
Active Ingredient Strength400 mg/1
Pharm ClassesMethylxanthine [EPC],Xanthines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52244-400-10

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52244-400-10)
Marketing Start Date2014-08-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52244-400-10 [52244040010]

Theo-24 CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA081034
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-08-25

Drug Details

Active Ingredients

IngredientStrength
THEOPHYLLINE ANHYDROUS400 mg/1

OpenFDA Data

SPL SET ID:7a108fa0-c230-475f-be93-6f864b98a410
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313310
  • 844590
  • 844591
  • 701712
  • 198264
  • 844829
  • 844813
  • 313272

    • Pharmacological Class

    • Methylxanthine [EPC]
    • Xanthines [CS]
    • Methylxanthine [EPC]
    • Xanthines [CS]

    Medicade Reported Pricing

    52244040010 THEO-24 ER 400 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Theo-24" or generic name "Theophylline Anhydrous"

    NDCBrand NameGeneric Name
    52244-100Theo-24theophylline anhydrous
    52244-200Theo-24theophylline anhydrous
    52244-300Theo-24theophylline anhydrous
    52244-400Theo-24theophylline anhydrous
    17856-0644ELIXOPHYLLINTHEOPHYLLINE ANHYDROUS
    49708-644ELIXOPHYLLINTHEOPHYLLINE ANHYDROUS
    68151-0644ELIXOPHYLLINTHEOPHYLLINE ANHYDROUS
    70408-644ELIXOPHYLLINTHEOPHYLLINE ANHYDROUS
    0121-4794TheophyllineTHEOPHYLLINE ANHYDROUS
    10135-604TheophyllineTheophylline Anhydrous
    60621-033TheophyllineTheophylline Anhydrous
    67781-251Uniphyltheophylline anhydrous
    67781-252Uniphyltheophylline anhydrous

    Trademark Results [Theo-24]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    THEO-24
    THEO-24
    74323632 1793370 Dead/Cancelled
    WHITBY, INC.
    1992-10-16
    THEO-24
    THEO-24
    73369262 1259784 Live/Registered
    Searle & Co.
    1982-06-14
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.