FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
51655-627
11-digit product format
516550627
Labeler code
51655
Product ID
51655-627_1aadd4c5-f8f9-4b97-825f-ab2855a611a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA078432
Marketing category
ANDA
Marketing start
2014-08-07
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
550 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-627-202026-01-08C16284748780-19d75b9d0-a04b-f424-e053-dadaa90a57ce00a746cd-5c7e-4b41-b4ac-3cfec36a5e2d
51655-627-202020-01-31C16284748780-19d75b9d0-a04b-f424-e053-dadaa90a57ce00a746cd-5c7e-4b41-b4ac-3cfec36a5e2d

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM (NAPROXEN) TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM (NAPROXEN) TABLET [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-627NAPROXEN SODIUM (NAPROXEN) TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Legacy NDC20141001_00a746cd-5c7e-4b41-b4ac-3cfec36a5e2d.zip