NDC 0904-6538

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 Major Pharmaceuticals. The primary component is Butalbital; Acetaminophen; Caffeine.

Product ID0904-6538_70830cbf-cb93-44e9-b179-1d920ca5c4b9
NDC0904-6538
Product TypeHuman Prescription Drug
Proprietary NameButalbital, Acetaminophen and Caffeine
Generic NameButalbital, Acetaminophen And Caffeine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1995-06-12
Marketing CategoryANDA / ANDA
Application NumberANDA089718
Labeler NameMajor Pharmaceuticals
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 0904-6538-60

100 TABLET in 1 BOTTLE, PLASTIC (0904-6538-60)
Marketing Start Date1995-06-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6538-06 [00904653806]

Butalbital, Acetaminophen and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA089718
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-06-12
Marketing End Date2020-04-30

NDC 0904-6538-60 [00904653860]

Butalbital, Acetaminophen and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA089718
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-06-12
Marketing End Date2020-03-31

NDC 0904-6538-80 [00904653880]

Butalbital, Acetaminophen and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA089718
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-06-12

NDC 0904-6538-40 [00904653840]

Butalbital, Acetaminophen and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA089718
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-06-12

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:19b523f6-6cfb-44a8-83d1-8bac5f7d6045
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
    0143-1787Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    0527-4094butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    0603-2544Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and Caffeine
    0904-6538Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    10135-628Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    10702-253Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    11534-187BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeine
    13107-075Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    13925-535BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeine
    13925-536BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeine
    17856-1787Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    21695-257Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    21695-843Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    42195-955Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    42254-323Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and Caffeine
    42543-094Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    43063-369Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    46672-053butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    46672-633butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    50090-2105Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    50268-139Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    50436-4856butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    51407-200BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeine
    51407-556Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    51672-4222Butalbital, Acetaminophen and Caffeinebutalbital, acetaminophen, and caffeine
    51862-179butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    68071-4657butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    68084-396BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
    68151-1313Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    68788-9025Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    68788-9711butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    71335-0347butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    71610-042butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    51862-540butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    52959-913Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    55289-879Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    55154-7147BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
    60429-589butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    61919-022BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
    63187-520butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    66267-039butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    67544-394Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    67296-0718Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
    55154-7988Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
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