Hydromorphone Hydrochloride

Product NDC

64850-402

11-digit product format

648500402

Labeler code

64850

Product ID

64850-402_45dd3cc4-05cb-4916-b367-0d761a34bbca

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydromorphone Hydrochloride

Dosage form

TABLET

Route

ORAL

Labeler

Elite Laboratories, Inc.

Application

ANDA076723

Marketing category

ANDA

Marketing start

2012-03-09

Marketing end

0000-00-00

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

2020-12-31

Current FDA listing

Historical FDA.report record