NDC 67544-394

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 Aphena Pharma Solutions - Tennessee, Llc. The primary component is Butalbital; Acetaminophen; Caffeine.

Product ID67544-394_68d8e3a9-cabb-46aa-b327-9d024d41a6e7
NDC67544-394
Product TypeHuman Prescription Drug
Proprietary NameButalbital, Acetaminophen and Caffeine
Generic NameButalbital, Acetaminophen, And Caffeine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2003-08-27
Marketing CategoryANDA / ANDA
Application NumberANDA040511
Labeler NameAphena Pharma Solutions - Tennessee, 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 67544-394-60

90 TABLET in 1 BOTTLE, PLASTIC (67544-394-60)
Marketing Start Date2003-08-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67544-394-60 [67544039460]

Butalbital, Acetaminophen and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA040511
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-08-27
Inactivation Date2020-01-31

NDC 67544-394-53 [67544039453]

Butalbital, Acetaminophen and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA040511
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-08-27
Inactivation Date2020-01-31

NDC 67544-394-30 [67544039430]

Butalbital, Acetaminophen and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA040511
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-08-27
Inactivation Date2020-01-31

NDC 67544-394-70 [67544039470]

Butalbital, Acetaminophen and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA040511
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-08-27
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:1434df11-6e37-4722-a4c0-972e5c5899f8
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
    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
    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
    51862-540butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
    51862-179butalbital, 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
    51407-200BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
    0143-0170Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    0527-1695Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    0591-2640Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    0591-3369Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    0722-7320Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    0904-6938Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    16714-170Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    21695-209Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    33358-059Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
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