NDC 46672-633

butalbital, acetaminophen and caffeine

Butalbital, Acetaminophen And Caffeine

butalbital, acetaminophen and caffeine is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Mikart, Llc. The primary component is Butalbital; Acetaminophen; Caffeine.

Product ID46672-633_9c6ef57c-30d4-060e-e053-2a95a90adc37
NDC46672-633
Product TypeHuman Prescription Drug
Proprietary Namebutalbital, acetaminophen and caffeine
Generic NameButalbital, Acetaminophen And Caffeine
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2003-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA040387
Labeler NameMikart, LLC
Substance NameBUTALBITAL; ACETAMINOPHEN; CAFFEINE
Active Ingredient Strength50 mg/15mL; mg/15mL; mg/15mL
Pharm ClassesBarbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 46672-633-16

473 mL in 1 BOTTLE, PLASTIC (46672-633-16)
Marketing Start Date2003-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46672-633-28 [46672063328]

butalbital, acetaminophen and caffeine SYRUP
Marketing CategoryANDA
Application NumberANDA040387
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-01-31

NDC 46672-633-16 [46672063316]

butalbital, acetaminophen and caffeine SYRUP
Marketing CategoryANDA
Application NumberANDA040387
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-01-31

NDC 46672-633-01 [46672063301]

butalbital, acetaminophen and caffeine SYRUP
Marketing CategoryANDA
Application NumberANDA040387
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-01-31

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/15mL

OpenFDA Data

SPL SET ID:3f0f6064-cc9f-491c-a940-3f087abbc774
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 756245

    • 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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