Butalbital, Acetaminophen and Caffeine

Product NDC

46672-633

11-digit product format

466720633

Labeler code

46672

Product ID

46672-633_aefaf972-392e-400c-e053-2a95a90aeab0

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

butalbital, acetaminophen and caffeine

Dosage form

SYRUP

Route

ORAL

Labeler

Mikart, LLC

Application

ANDA040387

Marketing category

ANDA

Marketing start

2003-01-31

Marketing end

0000-00-00

Substance

BUTALBITAL; ACETAMINOPHEN; CAFFEINE

Active strength

50 mg/15mL; mg/15mL; mg/15mL

Pharmacologic classes

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

DEA schedule

CIII

NDC exclude flag

No

Listing certified through

2021-12-31

Current FDA listing

Historical FDA.report record