FDA.reportPublic FDA data

Medique Mediproxen

Product NDC
50090-2388
11-digit product format
500902388
Labeler code
50090
Product ID
50090-2388_f7b46e9e-17ec-4b58-8bec-ccd3c5ffc6e9
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079096
Marketing category
ANDA
Marketing start
2008-12-30
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
Medique Mediproxen
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
50090-2388-02023-02-07C16284748780-1f386c649-9b38-0266-e053-dadaa90a7c1aMedique Mediproxen
50090-2388-02023-01-30C16284748780-1f386c649-9b38-0266-e053-dadaa90a7c1aMedique Mediproxen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2388-0Medique Mediproxen1 in 1 PACKETTABLET, FILM COATED119
50090-2388-0Medique Mediproxen100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2388-0EA - Each50090-238896889502-616c-48b0-bfaf-ead4ba15e61712021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2388MEDIQUE MEDIPROXEN (NAPROXEN SODIUM) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]19Current NDC, Legacy NDC, 2 package rows20240203_2d04fef4-6a26-4df2-af90-816107e7dfe2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN2d04fef4-6a26-4df2-af90-816107e7dfe219
849574naproxen sodium 220 MG Oral TabletSCD2d04fef4-6a26-4df2-af90-816107e7dfe219
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY2d04fef4-6a26-4df2-af90-816107e7dfe219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2388-050090238800100 PACKET in 1 BOX, UNIT-DOSE (50090-2388-0) / 1 TABLET, FILM COATED in 1 PACKET100 packet2016-04-280000-00-00NoNoCurrent