NDC 0527-1312

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 Lannett Company, Inc.. The primary component is Butalbital; Aspirin; Caffeine; Codeine Phosphate.

Product ID0527-1312_796368e4-ab65-44af-a0d1-470d1c6ed0f9
NDC0527-1312
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 Date1998-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA074951
Labeler NameLannett Company, Inc.
Substance NameBUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE
Active Ingredient Strength50 mg/1; 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],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0527-1312-01

100 CAPSULE in 1 BOTTLE (0527-1312-01)
Marketing Start Date1998-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0527-1312-01 [00527131201]

Butalbital, Aspirin, Caffeine and Codeine Phosphate CAPSULE
Marketing CategoryANDA
Application NumberANDA074951
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-08-31

Drug Details

Active Ingredients

IngredientStrength
BUTALBITAL50 mg/1

OpenFDA Data

SPL SET ID:04bddbc4-86c7-4bac-9327-010568020568
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]
  • UPC Code
  • 0305271312013
  • 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]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]

    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

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