EC-Naprosyn

Product NDC

0004-6415

11-digit product format

000046415

Labeler code

0004

Product ID

0004-6415_517eb011-7a8b-42e8-9063-cd4d655601c1

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

naproxen

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Labeler

Genentech, Inc.

Application

NDA020067

Marketing category

NDA

Marketing start

1994-10-14

Marketing end

2019-05-31

Substance

NAPROXEN

Active strength

375 mg/1

Pharmacologic classes

Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record