NDC 0591-3219

Butalbital, Aspirin, and Caffeine

Butalbital, Aspirin, And Caffeine

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

Product ID0591-3219_2e5315af-f5b8-4eb1-b019-5cfcd71d9820
NDC0591-3219
Product TypeHuman Prescription Drug
Proprietary NameButalbital, Aspirin, and Caffeine
Generic NameButalbital, Aspirin, And Caffeine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2003-10-06
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA017534
Labeler NameActavis Pharma, Inc.
Substance NameBUTALBITAL; ASPIRIN; CAFFEINE
Active Ingredient Strength50 mg/1; mg/1; mg/1
Pharm ClassesBarbiturates [CS],Barbiturate [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0591-3219-01

100 CAPSULE in 1 BOTTLE (0591-3219-01)
Marketing Start Date2003-10-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-3219-01 [00591321901]

Butalbital, Aspirin, and Caffeine CAPSULE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA017534
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-10-06

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:e31096f4-162f-44bd-a211-9c2873acfe54
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238134
  • Pharm Class PE
  • Decreased Prostaglandin Production [PE]
  • Decreased Platelet Aggregation [PE]
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Platelet Aggregation Inhibitor [EPC]
  • UPC Code
  • 0305913219014
  • 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]

    NDC Crossover Matching brand name "Butalbital, Aspirin, and Caffeine" or generic name "Butalbital, Aspirin, And Caffeine"

    NDCBrand NameGeneric Name
    0527-1552Butalbital, aspirin, and caffeineButalbital, aspirin, and caffeine
    0591-3219Butalbital, Aspirin, and Caffeinebutalbital, aspirin, and caffeine
    21695-139Butalbital, Aspirin, and Caffeinebutalbital, aspirin, and caffeine
    29033-215Butalbital, Aspirin, and CaffeineButalbital, Aspirin, and Caffeine
    33261-922Butalbital, Aspirin, and Caffeinebutalbital, aspirin, and caffeine
    50090-1580Butalbital, aspirin, and caffeineButalbital, aspirin, and caffeine
    55700-129Butalbital, aspirin, and caffeineButalbital, aspirin, and caffeine
    62135-433butalbital, aspirin, and caffeinebutalbital, aspirin, and caffeine
    79739-7192Butalbital, Aspirin, and CaffeineButalbital, Aspirin, and Caffeine
    0023-6146FiorinalButalbital, Aspirin, and Caffeine
    52544-955FiorinalButalbital, Aspirin, and Caffeine

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