naproxen

Product NDC

55700-463

11-digit product format

557000463

Labeler code

55700

Product ID

55700-463_62304862-d1ea-4e2f-9d7c-4a3e5f7aed0c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

naproxen

Dosage form

TABLET

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA091305

Marketing category

ANDA

Marketing start

2016-07-05

Marketing end

0000-00-00

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

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record