SYMPROIC

Product NDC

59630-222

11-digit product format

596300222

Labeler code

59630

Product ID

59630-222_b3c6525c-fd16-02b9-e053-2995a90a8b95

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

naldemedine

Dosage form

TABLET

Route

ORAL

Labeler

Shionogi Inc.

Application

NDA208854

Marketing category

NDA

Marketing start

2018-07-05

Marketing end

2020-12-31

Substance

NALDEMEDINE TOSYLATE

Active strength

0 mg/1

Pharmacologic classes

Opioid Antagonist [EPC],Opioid Antagonists [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record