hydrocodone bitartrate and acetaminophen

Product NDC

46672-166

11-digit product format

466720166

Labeler code

46672

Product ID

46672-166_acd89c6b-74e3-6782-e053-2995a90a1985

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

hydrocodone bitartrate and acetaminophen

Dosage form

TABLET

Route

ORAL

Labeler

Mikart, LLC

Application

ANDA040658

Marketing category

ANDA

Marketing start

2006-03-24

Marketing end

0000-00-00

Substance

HYDROCODONE BITARTRATE; ACETAMINOPHEN

Active strength

8 mg/1; mg/1

Pharmacologic classes

Opioid Agonist [EPC],Opioid Agonists [MoA]

DEA schedule

CII

NDC exclude flag

No

Listing certified through

2021-12-31

Current FDA listing

Historical FDA.report record