ALLZITAL

Product NDC

70362-722

11-digit product format

703620722

Labeler code

70362

Product ID

70362-722_b43ed65f-1e38-fff8-e053-2a95a90a2c39

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

butalbital and acetaminophen

Dosage form

TABLET

Route

ORAL

Labeler

Skylar Laboratories, LLC

Application

ANDA203484

Marketing category

ANDA

Marketing start

2015-12-04

Marketing end

2020-12-06

Substance

BUTALBITAL; ACETAMINOPHEN

Active strength

25 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