Naproxen

Product NDC
90096-161
11-digit product format
900960161
Labeler code
90096
Product ID
90096-161_1e574b03-a038-453b-b84f-9437fc2df0f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Zameer Pharmaceuticals LLC
Application
NDA020067
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-08-31
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
Rxcui311915

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
90096-161-01Naproxen100 in 1 BOTTLETABLET, DELAYED RELEASE1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311915naproxen 500 MG Delayed Release Oral TabletPSNd2e5553a-7c90-407c-9f07-3be65560c23a1
311915naproxen 500 MG Delayed Release Oral TabletSCDd2e5553a-7c90-407c-9f07-3be65560c23a1
311915naproxen (as naproxen sodium) 500 MG Delayed Release Oral TabletSYd2e5553a-7c90-407c-9f07-3be65560c23a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
90096-161-0190096016101100 TABLET, DELAYED RELEASE in 1 BOTTLE (90096-161-01) 2025-08-31NoNoCurrent