NDC 0121-4794

Theophylline

Theophylline Anhydrous

Theophylline is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is Theophylline Anhydrous.

Product ID0121-4794_d0cc7207-c3ca-4f0b-99b6-82409a0a0255
NDC0121-4794
Product TypeHuman Prescription Drug
Proprietary NameTheophylline
Generic NameTheophylline Anhydrous
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2008-11-03
Marketing CategoryANDA / ANDA
Application NumberANDA085186
Labeler NamePharmaceutical Associates, Inc.
Substance NameTHEOPHYLLINE ANHYDROUS
Active Ingredient Strength80 mg/15mL
Pharm ClassesMethylxanthine [EPC],Xanthines [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0121-4794-15

4 TRAY in 1 CASE (0121-4794-15) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE
Marketing Start Date2008-11-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-4794-15 [00121479415]

Theophylline SOLUTION
Marketing CategoryANDA
Application NumberANDA085186
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-11-03
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
THEOPHYLLINE ANHYDROUS80 mg/15mL

OpenFDA Data

SPL SET ID:c248b178-951c-4710-933b-d9a6a8555688
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313306
  • Pharmacological Class

    • Methylxanthine [EPC]
    • Xanthines [CS]

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

    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
    68151-1393TheophyllineTheophylline
    68462-380TheophyllineTheophylline
    68462-356TheophyllineTheophylline
    68788-0453TheophyllineTheophylline
    50111-518TheophyllineTheophylline
    50111-483TheophyllineTheophylline
    53808-0982TheophyllineTheophylline
    54838-556TheophyllineTheophylline
    60621-033TheophyllineTheophylline
    60687-258TheophyllineTheophylline
    62332-026TheophyllineTheophylline
    62332-025TheophyllineTheophylline
    63629-5198TheophyllineTheophylline
    63629-2792TheophyllineTheophylline
    17856-0644ELIXOPHYLLINTHEOPHYLLINE ANHYDROUS
    49708-644ELIXOPHYLLINTHEOPHYLLINE ANHYDROUS
    16571-011Theophylline(Anhydrous)Theophylline

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