Butalbital, Acetaminophen, and Caffeine

Product NDC

68071-3120

11-digit product format

680713120

Labeler code

68071

Product ID

68071-3120_4a638186-a9b5-0503-e054-00144ff8d46c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Butalbital, Acetaminophen, and Caffeine

Dosage form

TABLET

Route

ORAL

Labeler

NuCare Pharmaceuticals, Inc.

Application

ANDA200243

Marketing category

ANDA

Marketing start

2012-09-13

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