Morphine Sulfate Extended-Release

Product NDC

57664-197

11-digit product format

576640197

Labeler code

57664

Product ID

57664-197_916c8c9c-c86a-4e82-9a89-cf0c7fdeb385

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Morphine Sulfate Extended-Release

Dosage form

TABLET

Route

ORAL

Labeler

Sun Pharmaceutical Industries, Inc.

Application

ANDA205634

Marketing category

ANDA

Marketing start

2016-09-13

Marketing end

0000-00-00

Substance

MORPHINE SULFATE

Active strength

200 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