NDC 68151-0644

ELIXOPHYLLIN

Theophylline Anhydrous

ELIXOPHYLLIN is a Oral Liquid in the Human Prescription Drug category. It is labeled and distributed by Carilion Materials Management. The primary component is Theophylline Anhydrous.

Product ID68151-0644_63856e3e-a575-4122-ba95-25c00d4219b8
NDC68151-0644
Product TypeHuman Prescription Drug
Proprietary NameELIXOPHYLLIN
Generic NameTheophylline Anhydrous
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2009-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA085186
Labeler NameCarilion Materials Management
Substance NameTHEOPHYLLINE ANHYDROUS
Active Ingredient Strength80 mg/15mL
Pharm ClassesMethylxanthine [EPC],Xanthines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68151-0644-1

20 mL in 1 SYRINGE, PLASTIC (68151-0644-1)
Marketing Start Date2017-12-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68151-0644-1 [68151064401]

ELIXOPHYLLIN LIQUID
Marketing CategoryANDA
Application NumberANDA085186
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
THEOPHYLLINE ANHYDROUS80 mg/15mL

OpenFDA Data

SPL SET ID:8328cefd-49aa-4621-a7c3-49a14a19cbe7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313306
  • 756226

    • Pharmacological Class

    • Methylxanthine [EPC]
    • Xanthines [CS]

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

    NDCBrand NameGeneric Name
    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
    67781-251Uniphyltheophylline anhydrous
    67781-252Uniphyltheophylline anhydrous

    Trademark Results [ELIXOPHYLLIN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ELIXOPHYLLIN
    ELIXOPHYLLIN
    72027239 0654047 Live/Registered
    SHERMAN LABORATORIES
    1957-03-29
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.