Hydrocodone Bitartrate and Homatropine Methylbromide

Product NDC

0574-1105

11-digit product format

005741105

Labeler code

0574

Product ID

0574-1105_d14e84cd-5205-4b1c-99b7-59d30b6ab09a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydrocodone bitartrate, homatropine methylbromide

Dosage form

SOLUTION

Route

ORAL

Labeler

Paddock Laboratories, LLC

Application

ANDA205731

Marketing category

ANDA

Marketing start

2017-06-16

Marketing end

2019-05-31

Substance

HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE

Active strength

5 mg/5mL; mg/5mL

Pharmacologic classes

Opioid Agonist [EPC],Opioid Agonists [MoA]

DEA schedule

CII

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record