NDC 63629-2952

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE

Butalbital, Aspirin, Caffeine And Codeine Phosphate

BUTALBITAL, ASPIRIN, 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; Aspirin; Caffeine; Codeine Phosphate.

Product ID63629-2952_0d4719d8-4e04-439d-953b-8cc5468619ca
NDC63629-2952
Product TypeHuman Prescription Drug
Proprietary NameBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE
Generic NameButalbital, Aspirin, Caffeine And Codeine Phosphate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2009-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA075231
Labeler NameBryant Ranch Prepack
Substance NameBUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE
Active Ingredient Strength50 mg/1; mg/1; mg/1; mg/1
Pharm ClassesBarbiturates [CS],Barbiturate [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],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 FlagE
Listing Certified Through2018-12-31

Packaging

NDC 63629-2952-1

30 CAPSULE in 1 BOTTLE (63629-2952-1)
Marketing Start Date2021-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-2952-4 [63629295204]

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE
Marketing CategoryANDA
Application NumberANDA075231
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-05-01
Inactivation Date2020-01-31

NDC 63629-2952-6 [63629295206]

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE
Marketing CategoryANDA
Application NumberANDA075231
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-05-01
Inactivation Date2020-01-31

NDC 63629-2952-5 [63629295205]

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE
Marketing CategoryANDA
Application NumberANDA075231
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-05-01
Inactivation Date2020-01-31

NDC 63629-2952-1 [63629295201]

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE
Marketing CategoryANDA
Application NumberANDA075231
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-05-01
Inactivation Date2020-01-31

NDC 63629-2952-3 [63629295203]

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE
Marketing CategoryANDA
Application NumberANDA075231
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-05-01
Inactivation Date2020-01-31

NDC 63629-2952-2 [63629295202]

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE
Marketing CategoryANDA
Application NumberANDA075231
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-05-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:95a33c9b-79a6-47c7-8433-fc217950b88f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 994237
  • Pharm Class PE
  • Decreased Prostaglandin Production [PE]
  • Decreased Platelet Aggregation [PE]
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Platelet Aggregation Inhibitor [EPC]
  • NUI Code
  • N0000008832
  • N0000008836
  • N0000175721
  • N0000000160
  • N0000175578
  • N0000175722
  • Pharmacological Class

    • Barbiturates [CS]
    • Barbiturate [EPC]
    • Cyclooxygenase Inhibitors [MoA]
    • Decreased Prostaglandin Production [PE]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Platelet Aggregation Inhibitor [EPC]
    • Decreased Platelet Aggregation [PE]
    • 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, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE" or generic name "Butalbital, Aspirin, Caffeine And Codeine Phosphate"

    NDCBrand NameGeneric Name
    0527-1312Butalbital, Aspirin, Caffeine and Codeine PhosphateButalbital, Aspirin, Caffeine and Codeine Phosphate
    0591-3546Butalbital, Aspirin, Caffeine and Codeine PhosphateButalbital, Aspirin, Caffeine and Codeine Phosphate
    63629-2952BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATEButalbital, Aspirin, Caffeine and Codeine Phosphate
    69238-1993Butalbital, Aspirin, Caffeine and Codeine PhosphateButalbital, Aspirin, Caffeine and Codeine Phosphate
    51991-074Ascomp with CodeineButalbital, Aspirin, Caffeine and Codeine Phosphate

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