Butalbital, Acetaminophen and Caffeine

Product NDC

50268-139

11-digit product format

502680139

Labeler code

50268

Product ID

50268-139_650bc9cc-1f1a-2370-e053-2991aa0a7aa8

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Butalbital, Acetaminophen and Caffeine

Dosage form

TABLET

Route

ORAL

Labeler

AvPAK

Application

ANDA089718

Marketing category

ANDA

Marketing start

2017-07-21

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