NDC 52544-082

Fioricet with Codeine

Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate

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

Product ID52544-082_25f6b2c1-33f2-4095-bec0-d5627b522308
NDC52544-082
Product TypeHuman Prescription Drug
Proprietary NameFioricet with Codeine
Generic NameButalbital, Acetaminophen, Caffeine, And Codeine Phosphate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2013-07-29
Marketing CategoryANDA / ANDA
Application NumberANDA076560
Labeler NameActavis Pharma, Inc.
Substance NameBUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE
Active Ingredient Strength50 mg/1; 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],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 52544-082-01

100 CAPSULE in 1 BOTTLE, PLASTIC (52544-082-01)
Marketing Start Date2013-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52544-082-01 [52544008201]

Fioricet with Codeine CAPSULE
Marketing CategoryANDA
Application NumberANDA076560
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-29

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:df9801fc-03fe-41da-a6b3-0f76788217c9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1431286
  • 1433802
    • UPC Code
  • 0352544082012

    • Pharmacological Class

    • Barbiturates [CS]
    • Barbiturate [EPC]
    • Central Nervous System Stimulant [EPC]
    • Methylxanthine [EPC]
    • Xanthines [CS]
    • Central Nervous System Stimulation [PE]
    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    NDC Crossover Matching brand name "Fioricet with Codeine" or generic name "Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate"

    NDCBrand NameGeneric Name
    52544-082Fioricet with CodeineButalbital, Acetaminophen, Caffeine, and Codeine Phosphate
    0591-2641Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine Phosphate
    0591-3220Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine Phosphate
    0603-2553Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine Phosphate
    0722-6670Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine Phosphate
    0722-7028Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine Phosphate
    63629-3152Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine Phosphate
    71335-0653Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine Phosphate
    79739-6670Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine Phosphate
    79739-7028Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateButalbital, Acetaminophen, Caffeine, and Codeine Phosphate
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