EMBEDA

Product NDC

60793-433

11-digit product format

607930433

Labeler code

60793

Product ID

60793-433_c44a9425-3894-424f-9f60-cbf08d358e3e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Labeler

Pfizer Laboratories Div Pfizer Inc

Application

NDA022321

Marketing category

NDA

Marketing start

2009-08-13

Marketing end

0000-00-00

Substance

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

Active strength

50 mg/1; mg/1

Pharmacologic classes

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

DEA schedule

CII

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record