NDC 21695-139

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 Rebel Distributors Corp. The primary component is Butalbital; Aspirin; Caffeine.

Product ID21695-139_aa9bfa49-c3b3-419d-a283-5ea0fd6fc3a0
NDC21695-139
Product TypeHuman Prescription Drug
Proprietary NameButalbital, Aspirin, and Caffeine
Generic NameButalbital, Aspirin, And Caffeine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2003-09-18
Marketing CategoryANDA / ANDA
Application NumberANDA086231
Labeler NameRebel Distributors Corp
Substance NameBUTALBITAL; ASPIRIN; CAFFEINE
Active Ingredient Strength50 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]
DEA ScheduleCIII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-139-60

60 CAPSULE in 1 BOTTLE (21695-139-60)
Marketing Start Date2003-09-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-139-60 [21695013960]

Butalbital, Aspirin, and Caffeine CAPSULE
Marketing CategoryANDA
Application NumberANDA086231
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-09-18
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:aa9bfa49-c3b3-419d-a283-5ea0fd6fc3a0
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]
    • 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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