Naproxen

Product NDC
25000-140
11-digit product format
250000140
Labeler code
25000
Product ID
25000-140_e5013319-e2f4-4cd0-9523-1ffd352fe2d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA091416
Marketing category
ANDA
Marketing start
2011-02-28
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
Rxcui198012, 198013, 198014

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
25000-140-03Naproxen30 in 1 BOTTLETABLET3014
25000-140-14Naproxen1000 in 1 BOTTLETABLET100014
25000-140-19Naproxen4 in 1 BOXTABLET414
25000-140-19Naproxen3500 in 1 BAGTABLET350014
25000-140-29Naproxen3500 in 1 BAGTABLET350014
25000-140-29Naproxen6 in 1 BOXTABLET614
25000-140-98Naproxen1 in 1 BOXTABLET114
25000-140-98Naproxen18975 in 1 BAGTABLET1897514

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [MARKSANS PHARMA LIMITED]4
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [MARKSANS PHARMA LIMITED]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [MARKSANS PHARMA LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [MARKSANS PHARMA LIMITED]4
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [MARKSANS PHARMA LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-140NAPROXEN TABLET [MARKSANS PHARMA LIMITED]14Current NDC, Legacy NDC, 8 package rows20241219_1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c814
198012naproxen 375 MG Oral TabletPSN1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c814
198014naproxen 500 MG Oral TabletPSN1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c814
198013naproxen 250 MG Oral TabletSCD1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c814
198012naproxen 375 MG Oral TabletSCD1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c814
198014naproxen 500 MG Oral TabletSCD1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25000-140-032500001400330 TABLET in 1 BOTTLE (25000-140-03) 30 tablet2011-02-280000-00-00NoNoCurrent
25000-140-14250000140141000 TABLET in 1 BOTTLE (25000-140-14) 1000 tablet2011-02-280000-00-00NoNoCurrent
25000-140-19250000140194 BAG in 1 BOX (25000-140-19) / 3500 TABLET in 1 BAG4 bag2011-02-280000-00-00NoNoCurrent
25000-140-29250000140296 BAG in 1 BOX (25000-140-29) / 3500 TABLET in 1 BAG6 bag2011-02-280000-00-00NoNoCurrent
25000-140-98250000140981 BAG in 1 BOX (25000-140-98) / 18975 TABLET in 1 BAG1 bag2011-02-280000-00-00NoNoCurrent