Butalbital and Acetaminophen

Product NDC

47781-535

11-digit product format

477810535

Labeler code

47781

Product ID

47781-535_41259940-9940-fcb0-5b71-47c6e678a87a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Butalbital and Acetaminophen

Dosage form

TABLET

Route

ORAL

Labeler

Alvogen, Inc.

Application

ANDA205120

Marketing category

ANDA

Marketing start

2017-02-24

Marketing end

2020-05-01

Substance

ACETAMINOPHEN; BUTALBITAL

Active strength

325 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