NDC 71335-0653

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 Bryant Ranch Prepack. The primary component is Butalbital; Acetaminophen; Caffeine; Codeine Phosphate.

Product ID71335-0653_a29db87b-3f50-40ca-a5ab-406028ff19f0
NDC71335-0653
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 Date2002-04-22
Marketing CategoryANDA / ANDA
Application NumberANDA075929
Labeler NameBryant Ranch Prepack
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 71335-0653-1

20 CAPSULE in 1 BOTTLE (71335-0653-1)
Marketing Start Date2018-01-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0653-6 [71335065306]

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE
Marketing CategoryANDA
Application NumberANDA075929
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-25
Marketing End Date2019-07-31

NDC 71335-0653-5 [71335065305]

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE
Marketing CategoryANDA
Application NumberANDA075929
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-25
Marketing End Date2019-07-31

NDC 71335-0653-1 [71335065301]

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE
Marketing CategoryANDA
Application NumberANDA075929
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-25
Marketing End Date2019-07-31

NDC 71335-0653-7 [71335065307]

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE
Marketing CategoryANDA
Application NumberANDA075929
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-25
Marketing End Date2019-07-31

NDC 71335-0653-2 [71335065302]

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE
Marketing CategoryANDA
Application NumberANDA075929
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-25
Marketing End Date2019-07-31

NDC 71335-0653-3 [71335065303]

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE
Marketing CategoryANDA
Application NumberANDA075929
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-25
Marketing End Date2019-07-31

NDC 71335-0653-4 [71335065304]

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE
Marketing CategoryANDA
Application NumberANDA075929
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-25
Marketing End Date2019-07-31

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:00431d9b-fe0b-4aab-9d18-ac6ee6b9d6fe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 993943

    • 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 "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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.