NDC 0121-4820

THEOPHYLLINE

Theophylline

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.

Product ID0121-4820_504d4800-cb3f-1148-e054-00144ff88e88
NDC0121-4820
Product TypeHuman Prescription Drug
Proprietary NameTHEOPHYLLINE
Generic NameTheophylline
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2016-12-16
Marketing CategoryANDA / ANDA
Application NumberANDA206344
Labeler NamePharmaceutical Associates, Inc.
Substance NameTHEOPHYLLINE
Active Ingredient Strength80 mg/15mL
Pharm ClassesMethylxanthine [EPC],Xanthines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0121-4820-40

4 TRAY in 1 CASE (0121-4820-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE (0121-4820-15)
Marketing Start Date2016-12-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-4820-15 [00121482015]

THEOPHYLLINE SOLUTION
Marketing CategoryANDA
Application NumberANDA206344
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-12-16

NDC 0121-4820-40 [00121482040]

THEOPHYLLINE SOLUTION
Marketing CategoryANDA
Application NumberANDA206344
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-12-16

Drug Details

Active Ingredients

IngredientStrength
THEOPHYLLINE80 mg/15mL

OpenFDA Data

SPL SET ID:32b9780f-c46f-4e0f-9641-2cab60600e6e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313306

    • Pharmacological Class

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

    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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