Arymo

Product NDC

69344-311

11-digit product format

693440311

Labeler code

69344

Product ID

69344-311_b6d00e41-aadf-4d1e-8f7e-960977d4289e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

morphine sulfate

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Zyla Life Sciences US Inc.

Application

NDA208603

Marketing category

NDA

Marketing start

2017-02-01

Marketing end

0000-00-00

Substance

MORPHINE SULFATE

Active strength

60 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