NDC 0722-7320

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 Nexgen Pharma, Inc.. The primary component is Butalbital; Acetaminophen; Caffeine.

Product ID0722-7320_3fc83e77-4fb0-4374-b7b0-19af4baa1a43
NDC0722-7320
Product TypeHuman Prescription Drug
Proprietary NameButalbital, Acetaminophen, and Caffeine
Generic NameButalbital, Acetaminophen, And Caffeine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA209587
Labeler NameNexgen Pharma, 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]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0722-7320-01

100 TABLET in 1 BOTTLE (0722-7320-01)
Marketing Start Date2016-09-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0722-7320-01 [00722732001]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA209587
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

NDC 0722-7320-05 [00722732005]

Butalbital, Acetaminophen, and Caffeine TABLET
Marketing CategoryANDA
Application NumberANDA209587
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-15

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:da9e77e3-9f64-402a-83ac-eb0dc3cd1abe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238154
    • UPC Code
  • 0307227320059
  • 0307227320011

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.