hydrocodone bitartrate and acetaminophen

Product NDC

46672-645

11-digit product format

466720645

Labeler code

46672

Product ID

46672-645_acc4d2a8-9bdb-fe2e-e053-2995a90a1d40

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

hydrocodone bitartrate and acetaminophen

Dosage form

SYRUP

Route

ORAL

Labeler

Mikart, LLC

Application

ANDA040881

Marketing category

ANDA

Marketing start

2010-02-25

Marketing end

0000-00-00

Substance

HYDROCODONE BITARTRATE; ACETAMINOPHEN

Active strength

10 mg/15mL; mg/15mL

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