Butalbital, Acetaminophen and Caffeine

Product NDC

55289-879

11-digit product format

552890879

Labeler code

55289

Product ID

55289-879_8b0f54b9-5ef8-e39e-e053-2a95a90ae0ee

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Butalbital, Acetaminophen, and Caffeine

Dosage form

TABLET

Route

ORAL

Labeler

PD-Rx Pharmaceuticals, Inc.

Application

ANDA040511

Marketing category

ANDA

Marketing start

2003-08-27

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

2020-12-31

Current FDA listing

Historical FDA.report record