Hydrocodone Bitatrate and Acetaminophen

Product NDC

55700-216

11-digit product format

557000216

Labeler code

55700

Product ID

55700-216_d9377108-02f5-41a6-ab2d-8cea27219cfe

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydrocodone Bitatrate and Acetaminophen

Dosage form

TABLET

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA040148

Marketing category

ANDA

Marketing start

2014-10-06

Marketing end

0000-00-00

Substance

HYDROCODONE BITARTRATE; ACETAMINOPHEN

Active strength

3 mg/1; mg/1

Pharmacologic classes

Opioid Agonist [EPC],Opioid Agonists [MoA]

DEA schedule

CII

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record