NDC 52544-080

Fioricet

Butalbital, Acetaminophen, And Caffeine

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

Product ID52544-080_120dced9-0659-4b61-bec7-d4ac87499a5b
NDC52544-080
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 NameActavis Pharma, Inc.
Substance NameACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active Ingredient Strength300 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]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 52544-080-01

100 CAPSULE in 1 BOTTLE (52544-080-01)
Marketing Start Date2013-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52544-080-01 [52544008001]

Fioricet CAPSULE
Marketing CategoryANDA
Application NumberANDA040885
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-29

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:c018be7d-f7b8-45e2-97b8-8e7a71740657
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1432261
  • 889520
  • UPC Code
  • 0352544080018
  • Pharmacological Class

    • Barbiturates [CS]
    • Barbiturate [EPC]
    • Central Nervous System Stimulant [EPC]
    • Methylxanthine [EPC]
    • Xanthines [CS]
    • Central Nervous System Stimulation [PE]

    Medicade Reported Pricing

    52544008001 FIORICET 50-300-40 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    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

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