Fiorinal

Product NDC

52544-955

11-digit product format

525440955

Labeler code

52544

Product ID

52544-955_d764eacb-cdb8-45a3-ad91-429b6c3f573b

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Butalbital, Aspirin, and Caffeine

Dosage form

CAPSULE

Route

ORAL

Labeler

Actavis Pharma, Inc.

Application

NDA017534

Marketing category

NDA

Marketing start

1976-05-04

Marketing end

2020-01-31

Substance

BUTALBITAL; ASPIRIN; CAFFEINE

Active strength

50 mg/1; mg/1; mg/1

Pharmacologic classes

Barbiturates [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 schedule

CIII

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record