Butalbital, Acetaminophen, and Caffeine

Product NDC

47781-536

11-digit product format

477810536

Labeler code

47781

Product ID

47781-536_036c682e-dbc5-884f-6d17-50dccaac184f

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

butalbital, acetaminophen, and caffeine

Dosage form

TABLET

Route

ORAL

Labeler

Alvogen Inc.

Application

ANDA204984

Marketing category

ANDA

Marketing start

2017-01-30

Marketing end

0000-00-00

Substance

BUTALBITAL; ACETAMINOPHEN; CAFFEINE

Active strength

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

Pharmacologic classes

Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record