FDA.reportPublic FDA data

Naproxen

Product NDC
42494-454
11-digit product format
424940454
Labeler code
42494
Product ID
42494-454_4f6fc436-1a5a-3dc2-e063-6394a90ace82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Cameron Pharmaceuticals
Application
ANDA091432
Marketing category
ANDA
Marketing start
2023-09-10
Marketing end
2026-11-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui311915, 603103

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
42494-454-102026-01-29C16284748780-149896155-d159-586f-e063-e6dba90add90These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
42494-454-102026-01-29C16284748780-149896155-d159-586f-e063-e6dba90add90These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42494-454-10Naproxen100 in 1 BOTTLE, PLASTICTABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42494-454-10EA - Each42494-4543761391f-09cb-4a78-8146-6e22c9544f5212023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42494-454NAPROXEN TABLET [CAMERON PHARMACEUTICALS]3Current NDC, 1 package rows20231014_2ae474dd-eaae-4401-8d42-613d672daea0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311915naproxen 500 MG Delayed Release Oral TabletPSN124af155-0661-4054-9800-de547d8212d7101
311915naproxen 500 MG Delayed Release Oral TabletSCD124af155-0661-4054-9800-de547d8212d7101
311915naproxen (as naproxen sodium) 500 MG Delayed Release Oral TabletSY124af155-0661-4054-9800-de547d8212d7101
603103naproxen 375 MG Delayed Release Oral TabletPSN2ae474dd-eaae-4401-8d42-613d672daea06
311915naproxen 500 MG Delayed Release Oral TabletPSN2ae474dd-eaae-4401-8d42-613d672daea06
603103naproxen 375 MG Delayed Release Oral TabletSCD2ae474dd-eaae-4401-8d42-613d672daea06
311915naproxen 500 MG Delayed Release Oral TabletSCD2ae474dd-eaae-4401-8d42-613d672daea06
311915naproxen (as naproxen sodium) 500 MG Delayed Release Oral TabletSY2ae474dd-eaae-4401-8d42-613d672daea06
603103naproxen 375 MG (as naproxen sodium 413 MG) Delayed Release Oral TabletSY2ae474dd-eaae-4401-8d42-613d672daea06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42494-454-1042494045410100 TABLET in 1 BOTTLE, PLASTIC (42494-454-10) 100 tablet2023-09-262026-11-30NoNoHistorical