NDC 71335-0365

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 Bryant Ranch Prepack. The primary component is Acetaminophen; Butalbital; Caffeine.

Product ID71335-0365_65bc1e24-0409-45ad-8b57-afc73e215114
NDC71335-0365
Product TypeHuman Prescription Drug
Proprietary NameButalbital, Acetaminophen, and Caffeine
Generic NameButalbital, Acetaminophen, And Caffeine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-09-13
Marketing CategoryANDA / ANDA
Application NumberANDA200243
Labeler NameBryant Ranch Prepack
Substance NameACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active Ingredient Strength325 mg/1; mg/1; mg/1
Pharm ClassesBarbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-0365-0

84 TABLET in 1 BOTTLE (71335-0365-0)
Marketing Start Date2021-12-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0365-4 [71335036504]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA200243
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-29
Inactivation Date2020-01-31
Reactivation Date2020-02-03

NDC 71335-0365-7 [71335036507]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA200243
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-29
Inactivation Date2020-01-31
Reactivation Date2020-02-03

NDC 71335-0365-1 [71335036501]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA200243
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-29
Inactivation Date2020-01-31
Reactivation Date2020-02-03

NDC 71335-0365-9 [71335036509]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA200243
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-29
Inactivation Date2020-01-31
Reactivation Date2020-02-03

NDC 71335-0365-2 [71335036502]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA200243
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-29
Inactivation Date2020-01-31
Reactivation Date2020-02-03

NDC 71335-0365-6 [71335036506]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA200243
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-29
Inactivation Date2020-01-31
Reactivation Date2020-02-03

NDC 71335-0365-5 [71335036505]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA200243
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-29
Inactivation Date2020-01-31
Reactivation Date2020-02-03

NDC 71335-0365-0 [71335036500]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA200243
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-29
Inactivation Date2020-01-31
Reactivation Date2020-02-03

NDC 71335-0365-3 [71335036503]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA200243
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-29
Inactivation Date2020-01-31
Reactivation Date2020-02-03

NDC 71335-0365-8 [71335036508]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA200243
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-29
Inactivation Date2020-01-31
Reactivation Date2020-02-03

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:65bc1e24-0409-45ad-8b57-afc73e215114
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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