Butalbital and Acetaminophen

Product NDC

69499-342

11-digit product format

694990342

Labeler code

69499

Product ID

69499-342_fbc28b29-53e9-42c1-afc0-47afdcf78dd7

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

butalbital and acetaminophen

Dosage form

CAPSULE

Route

ORAL

Labeler

Solubiomix

Application

ANDA207313

Marketing category

ANDA

Marketing start

2018-08-12

Marketing end

2020-11-13

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