NDC 65084-454

Fioricet

Butalbital, Acetaminophen, And Caffeine

Fioricet is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Mckesson Rxpak Inc. The primary component is Butalbital; Acetaminophen; Caffeine.

Product ID65084-454_b8d921a9-9c57-4432-b1fb-143d8e61a1a7
NDC65084-454
Product TypeHuman Prescription Drug
Proprietary NameFioricet
Generic NameButalbital, Acetaminophen, And Caffeine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2013-07-29
Marketing CategoryANDA / ANDA
Application NumberANDA040885
Labeler NameMckesson Rxpak 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 Through2019-12-31

Packaging

NDC 65084-454-10

100 CAPSULE in 1 BOTTLE (65084-454-10)
Marketing Start Date2014-01-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65084-454-41 [65084045441]

Fioricet CAPSULE
Marketing CategoryANDA
Application NumberANDA040885
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-08
Marketing End Date2019-06-13

NDC 65084-454-10 [65084045410]

Fioricet CAPSULE
Marketing CategoryANDA
Application NumberANDA040885
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-30
Marketing End Date2019-09-01

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:5d248332-87ff-45c2-be92-e9e8386a4749
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1432261
  • 889520

    • 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 "Fioricet" or generic name "Butalbital, Acetaminophen, And Caffeine"

    NDCBrand NameGeneric Name
    52544-080FioricetButalbital, Acetaminophen, and Caffeine
    55154-3416FioricetFioricet
    65084-454FioricetFioricet
    0603-2544Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and Caffeine
    42254-323Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and Caffeine
    51672-4222Butalbital, Acetaminophen and Caffeinebutalbital, acetaminophen, and caffeine
    52959-913Butalbital, 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
    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
    53002-6030Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine
    50268-553Butalbital, Acetaminophen, CaffeineButalbital, Acetaminophen, and Caffeine

    Trademark Results [Fioricet]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FIORICET
    FIORICET
    73121025 1080168 Live/Registered
    SANDOZ, INC.
    1977-03-31
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