NDC 0591-3220

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate

Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate

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

Product ID0591-3220_91a4b0d2-3c8f-4cf9-8684-ea0d1d940873
NDC0591-3220
Product TypeHuman Prescription Drug
Proprietary NameButalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Generic NameButalbital, Acetaminophen, Caffeine, And Codeine Phosphate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2003-09-18
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020232
Labeler NameActavis Pharma, Inc.
Substance NameCODEINE PHOSPHATE; BUTALBITAL; CAFFEINE; ACETAMINOPHEN
Active Ingredient Strength30 mg/1; mg/1; mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC],Barbiturates [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 0591-3220-01

100 CAPSULE in 1 BOTTLE (0591-3220-01)
Marketing Start Date2003-09-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-3220-01 [00591322001]

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA020232
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-09-18

Drug Details

Active Ingredients

IngredientStrength
CODEINE PHOSPHATE30 mg/1

OpenFDA Data

SPL SET ID:a58819b8-a52c-44a7-9ab0-c74480d98506
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993943
  • UPC Code
  • 0305913220010
  • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]
    • 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, Caffeine, and Codeine Phosphate" or generic name "Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate"

    NDCBrand NameGeneric Name
    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
    52544-082Fioricet with CodeineButalbital, Acetaminophen, Caffeine, and Codeine Phosphate

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