NDC 68788-9287

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 Preferred Pharmaceuticals Inc.. The primary component is Butalbital; Acetaminophen; Caffeine.

Product ID68788-9287_3c4c8d66-efa6-4831-b656-00ecbe867ece
NDC68788-9287
Product TypeHuman Prescription Drug
Proprietary NameButalbital, Acetaminophen, and Caffeine
Generic NameButalbital, Acetaminophen, And Caffeine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-05-08
Marketing CategoryANDA / ANDA
Application NumberANDA088616
Labeler NamePreferred Pharmaceuticals Inc.
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 68788-9287-1

100 TABLET in 1 BOTTLE (68788-9287-1)
Marketing Start Date2015-05-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-9287-6 [68788928706]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA088616
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-08
Inactivation Date2020-01-31

NDC 68788-9287-9 [68788928709]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA088616
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-08
Inactivation Date2020-01-31

NDC 68788-9287-3 [68788928703]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA088616
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-08
Inactivation Date2020-01-31

NDC 68788-9287-8 [68788928708]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA088616
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-08
Inactivation Date2020-01-31

NDC 68788-9287-1 [68788928701]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA088616
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-08
Inactivation Date2020-01-31

NDC 68788-9287-2 [68788928702]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA088616
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-08
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:d134544e-e54c-41fd-8c89-d7f017fb0829
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
    0143-0170Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    0527-1695Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    0527-4095Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine Capsules
    0591-2640Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    0591-3369Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    0722-7029Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine Capsules
    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
    42291-181Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    45865-352Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    47781-536Butalbital, Acetaminophen, and Caffeinebutalbital, acetaminophen, and caffeine
    47781-625Butalbital, Acetaminophen, and Caffeinebutalbital, acetaminophen, and caffeine
    50090-0371Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    50090-2564Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    50436-1695Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    50436-3369Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    68071-3249Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    68071-3120Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    68788-6939Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    68788-9287Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    70518-1134Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    71335-0365Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    53002-6030Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    55700-662Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    63187-933Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    63629-8392Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    79739-7320Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    70710-1378Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    0603-2544Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and Caffeine
    42254-323Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and Caffeine
    51672-4222Butalbital, Acetaminophen and Caffeinebutalbital, acetaminophen, and caffeine
    50268-553Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and Caffeine
    52544-080FioricetButalbital, Acetaminophen, and Caffeine
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