FDA.reportPublic FDA data

Medique Mediproxen

Product NDC
85766-121
11-digit product format
857660121
Labeler code
85766
Product ID
85766-121_50321e2e-561d-6ac3-e063-6394a90a6780
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sportpharm LLC
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Medique Mediproxen
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85766-121-01Medique Mediproxen1 in 1 PACKETTABLET, FILM COATED12
85766-121-10Medique Mediproxen100 in 1 BOXTABLET, FILM COATED1002
85766-121-50Medique Mediproxen50 in 1 BOXTABLET, FILM COATED502
85766-121-50Medique Mediproxen1 in 1 PACKETTABLET, FILM COATED12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNf01adfcc-b32a-4a98-a4e7-2ce87b824b5a2
849574naproxen sodium 220 MG Oral TabletSCDf01adfcc-b32a-4a98-a4e7-2ce87b824b5a2
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYf01adfcc-b32a-4a98-a4e7-2ce87b824b5a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-121-01857660121011 TABLET, FILM COATED in 1 PACKET (85766-121-01) 2025-12-17NoNoHistorical
85766-121-1085766012110100 PACKET in 1 BOX (85766-121-10) / 1 TABLET, FILM COATED in 1 PACKET (85766-121-01) 100 packet2025-12-17NoNoHistorical
85766-121-508576601215050 PACKET in 1 BOX (85766-121-50) / 1 TABLET, FILM COATED in 1 PACKET50 packet2025-12-17NoNoHistorical