Fiorinal with Codeine

Product NDC

52544-956

11-digit product format

525440956

Labeler code

52544

Product ID

52544-956_a08cf4c7-a32d-4941-b44e-f524d909944b

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Butalbital, Aspirin, Caffeine, and Codeine Phosphate

Dosage form

CAPSULE

Route

ORAL

Labeler

Actavis Pharma, Inc.

Application

NDA019429

Marketing category

NDA

Marketing start

1990-10-26

Marketing end

2020-03-31

Substance

CODEINE PHOSPHATE; BUTALBITAL; CAFFEINE; ASPIRIN

Active strength

30 mg/1; mg/1; mg/1; mg/1

Pharmacologic classes

Full Opioid Agonists [MoA],Opioid Agonist [EPC],Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],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]

DEA schedule

CIII

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record