FDA.reportPublic FDA data

NAPROXEN

Product NDC
51655-621
11-digit product format
516550621
Labeler code
51655
Product ID
51655-621_494f2182-140c-e7cc-e063-6394a90a093a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA091416
Marketing category
ANDA
Marketing start
2020-07-06
Substance
NAPROXEN
Active strength
500 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NAPROXEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-621-202026-01-29C16284748780-149896155-d656-586f-e063-e6dba90add90f32d755e-4984-ee40-e053-2995a90a4ebe
51655-621-252026-01-29C16284748780-149896155-d656-586f-e063-e6dba90add90f32d755e-4984-ee40-e053-2995a90a4ebe
51655-621-832026-01-29C16284748780-149896155-d656-586f-e063-e6dba90add90f32d755e-4984-ee40-e053-2995a90a4ebe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-621-20NAPROXEN20 in 1 BOTTLE, PLASTICTABLET202
51655-621-25NAPROXEN60 in 1 BOTTLE, PLASTICTABLET602
51655-621-83NAPROXEN180 in 1 BOTTLE, PLASTICTABLET1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-621NAPROXEN TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 3 package rows20230320_f32d755e-4984-ee40-e053-2995a90a4ebe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNf32d755e-4984-ee40-e053-2995a90a4ebe2
198014naproxen 500 MG Oral TabletSCDf32d755e-4984-ee40-e053-2995a90a4ebe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-621-205165506212020 TABLET in 1 BOTTLE, PLASTIC (51655-621-20) 20 tablet2020-07-06NoNoHistorical
51655-621-255165506212560 TABLET in 1 BOTTLE, PLASTIC (51655-621-25) 60 tablet2020-07-06NoNoHistorical
51655-621-8351655062183180 TABLET in 1 BOTTLE, PLASTIC (51655-621-83) 180 tablet2020-07-06NoNoHistorical