NDC 49999-151

Butalbital Acetaminophen and Caffeine

Butalbital Acetaminophen And Caffeine

Butalbital Acetaminophen and Caffeine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Butalbital; Acetaminophen; Caffeine.

Product ID49999-151_3ee7a685-a926-42b2-ab42-4c7633d50d10
NDC49999-151
Product TypeHuman Prescription Drug
Proprietary NameButalbital Acetaminophen and Caffeine
Generic NameButalbital Acetaminophen And Caffeine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-10-11
Marketing CategoryANDA / ANDA
Application NumberANDA088616
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameBUTALBITAL; ACETAMINOPHEN; CAFFEINE
Active Ingredient Strength50 mg/1; mg/1; mg/1
Pharm ClassesBarbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 49999-151-20

20 TABLET in 1 BOTTLE, PLASTIC (49999-151-20)
Marketing Start Date2010-10-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49999-151-30 [49999015130]

Butalbital Acetaminophen and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA088616
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-11
Marketing End Date2019-10-11

NDC 49999-151-20 [49999015120]

Butalbital Acetaminophen and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA088616
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-11
Marketing End Date2019-10-11

NDC 49999-151-60 [49999015160]

Butalbital Acetaminophen and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA088616
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-10-11
Marketing End Date2019-10-15

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:f988e6f2-1e5b-416b-8f2a-aa45a3207945
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238154

    • Pharmacological Class

    • Barbiturates [CS]
    • Barbiturate [EPC]
    • Central Nervous System Stimulant [EPC]
    • Methylxanthine [EPC]
    • Xanthines [CS]
    • Central Nervous System Stimulation [PE]

    NDC Crossover Matching brand name "Butalbital Acetaminophen and Caffeine" or generic name "Butalbital Acetaminophen And Caffeine"

    NDCBrand NameGeneric Name
    49999-151Butalbital Acetaminophen and CaffeineButalbital Acetaminophen and Caffeine
    51655-590Butalbital Acetaminophen and CaffeineButalbital Acetaminophen and Caffeine
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.