Hydromorphone Hydrochloride

Product NDC

0406-3308

11-digit product format

004063308

Labeler code

0406

Product ID

0406-3308_57abc171-371a-4a09-bb51-e2d84627777c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydromorphone Hydrochloride

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

SpecGx LLC

Application

NDA021217

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

2014-06-12

Marketing end

2020-12-31

Substance

HYDROMORPHONE HYDROCHLORIDE

Active strength

8 mg/1

Pharmacologic classes

Full Opioid Agonists [MoA],Opioid Agonist [EPC]

DEA schedule

CII

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record