FDA.reportPublic FDA data

Naproxen sodium

Product NDC
50090-5238
11-digit product format
500905238
Labeler code
50090
Product ID
50090-5238_a4e99a96-8609-4a3c-987a-42be7d2e1dab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078486
Marketing category
ANDA
Marketing start
2016-04-26
Substance
NAPROXEN SODIUM
Active strength
550 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 sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM550 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849431

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
50090-5238-32023-02-07C16284748780-1f386c649-fc8c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
50090-5238-52023-02-07C16284748780-1f386c649-fc8c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
50090-5238-62023-02-07C16284748780-1f386c649-fc8c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
50090-5238-32023-01-30C16284748780-1f386c649-fc8c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
50090-5238-52023-01-30C16284748780-1f386c649-fc8c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
50090-5238-62023-01-30C16284748780-1f386c649-fc8c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5238-3Naproxen sodium20 in 1 BOTTLETABLET, FILM COATED207
50090-5238-5Naproxen sodium30 in 1 BOTTLETABLET, FILM COATED307
50090-5238-6Naproxen sodium60 in 1 BOTTLETABLET, FILM COATED607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5238-3EA - Each50090-5238018ee6e6-2c21-4e27-8849-e25ce481f26212025-01-14
50090-5238-5EA - Each50090-5238be2ba7e5-6e44-4888-81f3-58e4b09e966712025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5238NAPROXEN SODIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 3 package rows20241115_8181bb7a-d917-4388-bcb0-a74671b07b06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSN8181bb7a-d917-4388-bcb0-a74671b07b067
849431naproxen sodium 550 MG Oral TabletSCD8181bb7a-d917-4388-bcb0-a74671b07b067
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY8181bb7a-d917-4388-bcb0-a74671b07b067

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5238-35009052380320 TABLET, FILM COATED in 1 BOTTLE (50090-5238-3) 2020-10-090000-00-00NoNoCurrent
50090-5238-55009052380530 TABLET, FILM COATED in 1 BOTTLE (50090-5238-5) 2020-10-090000-00-00NoNoCurrent
50090-5238-65009052380660 TABLET, FILM COATED in 1 BOTTLE (50090-5238-6) 2020-10-090000-00-00NoNoCurrent