Hydrocodone Polistirex and Chlorpheniramine Polistirex Pennkinetic

Product NDC

62175-490

11-digit product format

621750490

Labeler code

62175

Product ID

62175-490_b1bbc13b-f00c-4337-a3dc-f08591620742

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

hydrocodone polistirex and chlorpheniramine polistirex

Dosage form

SUSPENSION, EXTENDED RELEASE

Route

ORAL

Labeler

Kremers Urban Pharmaceuticals Inc.

Application

NDA019111

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

1987-12-31

Marketing end

0000-00-00

Substance

HYDROCODONE; CHLORPHENIRAMINE

Active strength

10 mg/5mL; mg/5mL

Pharmacologic classes

Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]

DEA schedule

CII

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record