"68308-312-10" National Drug Code (NDC)

Butalbital, Aspirin, Caffeine, And Codeine Phosphate 100 CAPSULE in 1 BOTTLE (68308-312-10)
(Mayne Pharma Inc.)

NDC Code68308-312-10
Package Description100 CAPSULE in 1 BOTTLE (68308-312-10)
Product NDC68308-312
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameButalbital, Aspirin, Caffeine, And Codeine Phosphate
Non-Proprietary NameButalbital, Aspirin, Caffeine, And Codeine Phosphate
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20151030
Marketing Category NameANDA
Application NumberANDA203335
ManufacturerMayne Pharma Inc.
Substance NameASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Strength325; 50; 40; 30
Strength Unitmg/1; mg/1; mg/1; mg/1
Pharmacy ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
DEA ScheduleCIII

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