Naproxen Sodium

Product NDC
50090-0685
11-digit product format
500900685
Labeler code
50090
Product ID
50090-0685_d4d91910-46d3-43d1-b15a-f3b511ff3b45
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074661
Marketing category
ANDA
Marketing start
2014-04-11
Substance
NAPROXEN SODIUM
Active strength
220 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 Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574

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
50090-0685-02023-02-07C16284748780-19d75b9d0-60bb-f424-e053-dadaa90a57cePerrigo Naproxen Sodium Tablets 220 mg Drug Facts
50090-0685-12023-02-07C16284748780-19d75b9d0-60bb-f424-e053-dadaa90a57cePerrigo Naproxen Sodium Tablets 220 mg Drug Facts
50090-0685-22023-02-07C16284748780-19d75b9d0-60bb-f424-e053-dadaa90a57cePerrigo Naproxen Sodium Tablets 220 mg Drug Facts
50090-0685-52023-02-07C16284748780-19d75b9d0-60bb-f424-e053-dadaa90a57cePerrigo Naproxen Sodium Tablets 220 mg Drug Facts
50090-0685-02023-01-30C16284748780-19d75b9d0-60bb-f424-e053-dadaa90a57cePerrigo Naproxen Sodium Tablets 220 mg Drug Facts
50090-0685-12023-01-30C16284748780-19d75b9d0-60bb-f424-e053-dadaa90a57cePerrigo Naproxen Sodium Tablets 220 mg Drug Facts
50090-0685-22023-01-30C16284748780-19d75b9d0-60bb-f424-e053-dadaa90a57cePerrigo Naproxen Sodium Tablets 220 mg Drug Facts
50090-0685-52023-01-30C16284748780-19d75b9d0-60bb-f424-e053-dadaa90a57cePerrigo Naproxen Sodium Tablets 220 mg Drug Facts
50090-0685-02021-09-16C16284748780-19d75b9d0-60bb-f424-e053-dadaa90a57cePerrigo Naproxen Sodium Tablets 220 mg Drug Facts
50090-0685-22021-09-16C16284748780-19d75b9d0-60bb-f424-e053-dadaa90a57cePerrigo Naproxen Sodium Tablets 220 mg Drug Facts
50090-0685-52021-09-16C16284748780-19d75b9d0-60bb-f424-e053-dadaa90a57cePerrigo Naproxen Sodium Tablets 220 mg Drug Facts
50090-0685-02020-01-31C16284748780-19d75b9d0-60bb-f424-e053-dadaa90a57cePerrigo Naproxen Sodium Tablets 220 mg Drug Facts
50090-0685-22020-01-31C16284748780-19d75b9d0-60bb-f424-e053-dadaa90a57cePerrigo Naproxen Sodium Tablets 220 mg Drug Facts
50090-0685-52020-01-31C16284748780-19d75b9d0-60bb-f424-e053-dadaa90a57cePerrigo Naproxen Sodium Tablets 220 mg Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0685-0Naproxen Sodium30 in 1 BOTTLETABLET, FILM COATED3021
50090-0685-1Naproxen Sodium10 in 1 BOTTLETABLET, FILM COATED1021
50090-0685-2Naproxen Sodium50 in 1 BOTTLETABLET, FILM COATED5021
50090-0685-5Naproxen Sodium14 in 1 BOTTLETABLET, FILM COATED1421

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0685-0EA - Each50090-0685a3ce0642-e172-4bf4-bc3e-4a9fe74413b312018-10-11
50090-0685-1EA - Each50090-068557b74d35-813a-4518-a884-cec50cacb26812023-06-06
50090-0685-2EA - Each50090-068567d5a70e-10a8-453c-90e7-079a46a13fe212018-10-11
50090-0685-5EA - Each50090-0685aed0c2d8-959c-4423-8a4d-dfb5d63d366312018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0685NAPROXEN SODIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]21Current NDC, Legacy NDC, 4 package rows20230429_2523a4de-1af9-46f4-93dc-e8b4029d69c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN2523a4de-1af9-46f4-93dc-e8b4029d69c421
849574naproxen sodium 220 MG Oral TabletSCD2523a4de-1af9-46f4-93dc-e8b4029d69c421
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY2523a4de-1af9-46f4-93dc-e8b4029d69c421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0685-05009006850030 TABLET, FILM COATED in 1 BOTTLE (50090-0685-0) 2014-11-280000-00-00NoNoCurrent
50090-0685-15009006850110 TABLET, FILM COATED in 1 BOTTLE (50090-0685-1) 2018-10-310000-00-00NoNoCurrent
50090-0685-25009006850250 TABLET, FILM COATED in 1 BOTTLE (50090-0685-2) 2014-11-280000-00-00NoNoCurrent
50090-0685-55009006850514 TABLET, FILM COATED in 1 BOTTLE (50090-0685-5) 2014-11-280000-00-00NoNoCurrent