butalbital and acetaminophen

Product NDC

47781-534

11-digit product format

477810534

Labeler code

47781

Product ID

47781-534_a20c4ee1-7add-7d1d-ca12-f6c76e3fab87

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

butalbital and acetaminophen

Dosage form

TABLET

Route

ORAL

Labeler

Alvogen Inc.

Application

ANDA207635

Marketing category

ANDA

Marketing start

2017-06-06

Marketing end

2020-09-01

Substance

BUTALBITAL; ACETAMINOPHEN

Active strength

50 mg/1; mg/1

Pharmacologic classes

Barbiturates [CS],Barbiturate [EPC]

DEA schedule

CIII

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record