NDC 0378-0487

Theophylline (Anhydrous)

Theophylline

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

Product ID0378-0487_c18d4391-fdf1-4393-b59f-7333685e5189
NDC0378-0487
Product TypeHuman Prescription Drug
Proprietary NameTheophylline (Anhydrous)
Generic NameTheophylline
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-03-07
Marketing CategoryANDA / ANDA
Application NumberANDA040560
Labeler NameMylan Pharamceuticals Inc.
Substance NameTHEOPHYLLINE ANHYDROUS
Active Ingredient Strength600 mg/1
Pharm ClassesMethylxanthine [EPC],Xanthines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0378-0487-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0487-01)
Marketing Start Date2017-03-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0487-01 [00378048701]

Theophylline (Anhydrous) TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040560
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-07
Marketing End Date2020-10-31

Drug Details

Active Ingredients

IngredientStrength
THEOPHYLLINE ANHYDROUS600 mg/1

OpenFDA Data

SPL SET ID:1f2a4716-34fe-4a2c-8bbf-5ed16772a967
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 348472
  • 313291

    • Pharmacological Class

    • Methylxanthine [EPC]
    • Xanthines [CS]

    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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