Hyrdomorphone Hydrochloride

Product NDC

68094-852

11-digit product format

680940852

Labeler code

68094

Product ID

68094-852_1fb60278-bfa9-4d2c-b9e6-3ce715c79355

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydromorphone Hydrochloride

Dosage form

TABLET

Route

ORAL

Labeler

Precision Dose Inc.

Application

ANDA076723

Marketing category

ANDA

Marketing start

2014-02-17

Marketing end

2019-08-31

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