FDA.reportPublic FDA data

Naproxen

Product NDC
76282-342
11-digit product format
762820342
Labeler code
76282
Product ID
76282-342_509fffe2-2bab-4ae4-8c53-520e1c5eff68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA091305
Marketing category
ANDA
Marketing start
2016-06-10
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198012, 198013, 198014

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-342-01Naproxen100 in 1 BOTTLETABLET1005
76282-342-05Naproxen500 in 1 BOTTLETABLET5005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-342NAPROXEN TABLET [EXELAN PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 2 package rows20200818_46dbdb95-a0d0-4410-8d64-b22763b12af7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN46dbdb95-a0d0-4410-8d64-b22763b12af75
198012naproxen 375 MG Oral TabletPSN46dbdb95-a0d0-4410-8d64-b22763b12af75
198014naproxen 500 MG Oral TabletPSN46dbdb95-a0d0-4410-8d64-b22763b12af75
198013naproxen 250 MG Oral TabletSCD46dbdb95-a0d0-4410-8d64-b22763b12af75
198012naproxen 375 MG Oral TabletSCD46dbdb95-a0d0-4410-8d64-b22763b12af75
198014naproxen 500 MG Oral TabletSCD46dbdb95-a0d0-4410-8d64-b22763b12af75
198013naproxen 250 MG Oral TabletPSNe2347581-90da-429a-b17c-cffd0039fb862
198012naproxen 375 MG Oral TabletPSNe2347581-90da-429a-b17c-cffd0039fb862
198014naproxen 500 MG Oral TabletPSNe2347581-90da-429a-b17c-cffd0039fb862
198013naproxen 250 MG Oral TabletSCDe2347581-90da-429a-b17c-cffd0039fb862
198012naproxen 375 MG Oral TabletSCDe2347581-90da-429a-b17c-cffd0039fb862
198014naproxen 500 MG Oral TabletSCDe2347581-90da-429a-b17c-cffd0039fb862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-342-0176282034201100 TABLET in 1 BOTTLE (76282-342-01) 100 tablet2016-06-100000-00-00NoNoCurrent
76282-342-0576282034205500 TABLET in 1 BOTTLE (76282-342-05) 500 tablet2016-06-100000-00-00NoNoCurrent