NDC 17856-0644

ELIXOPHYLLIN

Theophylline Anhydrous

ELIXOPHYLLIN is a Oral Liquid in the Human Prescription Drug category. It is labeled and distributed by Atlantic Biologicals Corps. The primary component is Theophylline Anhydrous.

Product ID17856-0644_a2be0daf-8d5e-469f-a61b-cfcee7a19c16
NDC17856-0644
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 NameAtlantic Biologicals Corps
Substance NameTHEOPHYLLINE ANHYDROUS
Active Ingredient Strength80 mg/15mL
Pharm ClassesMethylxanthine [EPC],Xanthines [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 17856-0644-2

18.75 mL in 1 CUP (17856-0644-2)
Marketing Start Date2009-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0644-2 [17856064402]

ELIXOPHYLLIN LIQUID
Marketing CategoryANDA
Application NumberANDA085186
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-05-09
Inactivation Date2020-01-31

NDC 17856-0644-3 [17856064403]

ELIXOPHYLLIN LIQUID
Marketing CategoryANDA
Application NumberANDA085186
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-10-01
Marketing End Date2012-05-09

NDC 17856-0644-1 [17856064401]

ELIXOPHYLLIN LIQUID
Marketing CategoryANDA
Application NumberANDA085186
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-05-09
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
THEOPHYLLINE ANHYDROUS80 mg/15mL

OpenFDA Data

SPL SET ID:7a5a367f-8461-4b15-99fc-f89aa7d5936e
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.