FDA.reportPublic FDA data

Naproxen

Product NDC
50090-5645
11-digit product format
500905645
Labeler code
50090
Product ID
50090-5645_35a43392-eb57-4493-be32-5c7e74b2fdd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA212517
Marketing category
ANDA
Marketing start
2020-03-01
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
Rxcui198014

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
50090-5645-02023-02-07C16284748780-1f386c649-a0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-5645-12023-02-07C16284748780-1f386c649-a0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-5645-22023-02-07C16284748780-1f386c649-a0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-5645-42023-02-07C16284748780-1f386c649-a0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-5645-52023-02-07C16284748780-1f386c649-a0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-5645-62023-02-07C16284748780-1f386c649-a0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-5645-72023-02-07C16284748780-1f386c649-a0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-5645-92023-02-07C16284748780-1f386c649-a0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-5645-02023-01-30C16284748780-1f386c649-a0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-5645-12023-01-30C16284748780-1f386c649-a0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-5645-22023-01-30C16284748780-1f386c649-a0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-5645-42023-01-30C16284748780-1f386c649-a0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-5645-52023-01-30C16284748780-1f386c649-a0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-5645-62023-01-30C16284748780-1f386c649-a0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-5645-72023-01-30C16284748780-1f386c649-a0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
50090-5645-92023-01-30C16284748780-1f386c649-a0e8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5645-0Naproxen15 in 1 BOTTLETABLET155
50090-5645-1Naproxen20 in 1 BOTTLETABLET205
50090-5645-2Naproxen30 in 1 BOTTLETABLET305
50090-5645-4Naproxen14 in 1 BOTTLETABLET145
50090-5645-5Naproxen40 in 1 BOTTLETABLET405
50090-5645-6Naproxen100 in 1 BOTTLETABLET1005
50090-5645-7Naproxen60 in 1 BOTTLETABLET605
50090-5645-9Naproxen6 in 1 BOTTLETABLET65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5645-0EA - Each50090-564516403720-0235-497a-833b-008844f373a512022-10-06
50090-5645-1EA - Each50090-5645128621c4-79c0-4b29-a7d8-0aa31613d6a512022-10-06
50090-5645-2EA - Each50090-56452e2fc428-7a46-4686-a385-abe42164d89a12022-10-06
50090-5645-4EA - Each50090-56453ff92097-207b-4d42-951b-367e1ce01f8d12022-10-06
50090-5645-5EA - Each50090-5645633f850f-cb02-427f-b212-31db5f3e3a7712022-10-06
50090-5645-6EA - Each50090-5645a3a9d694-866b-43e3-ada8-f86a2edce81e12022-10-06
50090-5645-7EA - Each50090-5645b5f25e7e-51a5-4fc2-b439-fd82681e3e9312022-10-06
50090-5645-9EA - Each50090-564562bf25b6-dc9a-4aca-a669-e9ffd9182a3712022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5645NAPROXEN TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 8 package rows20250508_7fef9311-471b-472c-b4f2-c952a2b3a255.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN7fef9311-471b-472c-b4f2-c952a2b3a2555
198014naproxen 500 MG Oral TabletSCD7fef9311-471b-472c-b4f2-c952a2b3a2555

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5645-05009056450015 TABLET in 1 BOTTLE (50090-5645-0) 15 tablet2021-09-130000-00-00NoNoCurrent
50090-5645-15009056450120 TABLET in 1 BOTTLE (50090-5645-1) 20 tablet2021-09-130000-00-00NoNoCurrent
50090-5645-25009056450230 TABLET in 1 BOTTLE (50090-5645-2) 30 tablet2021-09-130000-00-00NoNoCurrent
50090-5645-45009056450414 TABLET in 1 BOTTLE (50090-5645-4) 14 tablet2021-09-130000-00-00NoNoCurrent
50090-5645-55009056450540 TABLET in 1 BOTTLE (50090-5645-5) 40 tablet2021-09-130000-00-00NoNoCurrent
50090-5645-650090564506100 TABLET in 1 BOTTLE (50090-5645-6) 100 tablet2021-09-130000-00-00NoNoCurrent
50090-5645-75009056450760 TABLET in 1 BOTTLE (50090-5645-7) 60 tablet2021-09-130000-00-00NoNoCurrent
50090-5645-9500905645096 TABLET in 1 BOTTLE (50090-5645-9) 6 tablet2021-09-130000-00-00NoNoCurrent