FDA.reportPublic FDA data

Naproxen

Product NDC
50268-594
11-digit product format
502680594
Labeler code
50268
Product ID
50268-594_4dc83c37-14a4-3873-e063-6294a90a08de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA075927
Marketing category
ANDA
Marketing start
2015-02-11
Substance
NAPROXEN
Active strength
250 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
NAPROXEN250 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50268-594-152022-02-03C16284748780-1d6a99b39-8799-a426-e053-dadaa90af4c2Naproxen Tablets, USP Rx Only These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. N A P R O X E N tablets, for oral use Initial U.S. Approval: 1976
50268-594-152022-02-03C16284748780-1d6a99b39-8799-a426-e053-dadaa90af4c2Naproxen Tablets, USP Rx Only These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. N A P R O X E N tablets, for oral use Initial U.S. Approval: 1976
50268-594-152022-01-28C16284748780-1d6a99b39-8799-a426-e053-dadaa90af4c2Naproxen Tablets, USP Rx Only These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. N A P R O X E N tablets, for oral use Initial U.S. Approval: 1976
50268-594-152022-01-28C16284748780-1d6a99b39-8799-a426-e053-dadaa90af4c2Naproxen Tablets, USP Rx Only These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. N A P R O X E N tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-594-11Naproxen1 in 1 BLISTER PACKTABLET110
50268-594-15Naproxen50 in 1 BOX, UNIT-DOSETABLET5010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-594-11EA - Each50268-594879920af-dee1-4d73-be0b-6b28d5234a1d12015-06-09
50268-594-15EA - Each50268-59495f9cdb4-dac1-467a-9372-6848ff8a09df12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [AVPAK]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [AVPAK]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [AVPAK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [AVPAK]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [AVPAK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-594NAPROXEN TABLET [AVPAK]8Current NDC, Legacy NDC, 2 package rows20240110_e6fbf8f1-b064-658d-17bb-e7d6320aa45f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSNe6fbf8f1-b064-658d-17bb-e7d6320aa45f10
198012naproxen 375 MG Oral TabletPSNe6fbf8f1-b064-658d-17bb-e7d6320aa45f10
198014naproxen 500 MG Oral TabletPSNe6fbf8f1-b064-658d-17bb-e7d6320aa45f10
198013naproxen 250 MG Oral TabletSCDe6fbf8f1-b064-658d-17bb-e7d6320aa45f10
198012naproxen 375 MG Oral TabletSCDe6fbf8f1-b064-658d-17bb-e7d6320aa45f10
198014naproxen 500 MG Oral TabletSCDe6fbf8f1-b064-658d-17bb-e7d6320aa45f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-594-11502680594111 in 1 BLISTER PACKHistorical
50268-594-155026805941550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-594-15) / 1 TABLET in 1 BLISTER PACK (50268-594-11) 50 blister pack2015-02-110000-00-00NoNoCurrent