Butalbital Acetaminophen and Caffeine

Product NDC

49999-151

11-digit product format

499990151

Labeler code

49999

Product ID

49999-151_3ee7a685-a926-42b2-ab42-4c7633d50d10

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Butalbital Acetaminophen and Caffeine

Dosage form

TABLET

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA088616

Marketing category

ANDA

Marketing start

2010-10-11

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