NDC 67781-251

Uniphyl

Theophylline Anhydrous

Uniphyl is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Purdue Pharmaceutical Products Lp. The primary component is Theophylline Anhydrous.

Product ID67781-251_64f121d8-f082-471a-9756-cc5ac544543c
NDC67781-251
Product TypeHuman Prescription Drug
Proprietary NameUniphyl
Generic NameTheophylline Anhydrous
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1982-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA087571
Labeler NamePurdue Pharmaceutical Products LP
Substance NameTHEOPHYLLINE ANHYDROUS
Active Ingredient Strength400 mg/1
Pharm ClassesMethylxanthine [EPC],Xanthines [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 67781-251-01

100 TABLET in 1 BOTTLE (67781-251-01)
Marketing Start Date1982-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67781-251-01 [67781025101]

Uniphyl TABLET
Marketing CategoryANDA
Application NumberANDA087571
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1982-09-01
Inactivation Date2019-11-13

NDC 67781-251-05 [67781025105]

Uniphyl TABLET
Marketing CategoryANDA
Application NumberANDA087571
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1982-09-01
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
THEOPHYLLINE ANHYDROUS400 mg/1

OpenFDA Data

SPL SET ID:c4c80b87-fc6e-436d-84de-7a0cd9d895eb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 348472
  • 844832
  • 844831
  • 313291
    • UPC Code
  • 0367781252012
  • 0367781251015

    • Pharmacological Class

    • Methylxanthine [EPC]
    • Xanthines [CS]

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

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

    Trademark Results [Uniphyl]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    UNIPHYL
    UNIPHYL
    73492602 1332816 Live/Registered
    Purdue Frederick Company; The
    1984-07-30
    UNIPHYL
    UNIPHYL
    73415357 1282995 Dead/Cancelled
    Purdue Frederick Company, The
    1983-04-26
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