FDA.reportPublic FDA data

Naproxen

Product NDC
68462-188
11-digit product format
684620188
Labeler code
68462
Product ID
68462-188_16372549-a419-4920-a200-5128017570ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA078250
Marketing category
ANDA
Marketing start
2007-07-01
Substance
NAPROXEN
Active strength
250 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
NAPROXEN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ, 9TN87S3A3C
Rxcui198012, 198013, 198014, 849398, 849431

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
68462-188-01Naproxen100 in 1 BOTTLETABLET10013
68462-188-05Naproxen500 in 1 BOTTLETABLET50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-188-01EA - Each68462-188b1d41af1-4ac7-4f78-8b6f-5dca7f39f33b12012-07-24
68462-188-05EA - Each68462-188c97a3c0c-7864-41af-9a26-b1bad42f0d3012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]4
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [REBEL DISTRIBUTORS CORP]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [PROFICIENT RX LP]1
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [REBEL DISTRIBUTORS CORP]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [PROFICIENT RX LP]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NAPROXEN TABLET [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNAPROXEN TABLET [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-188NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]12Current NDC, Legacy NDC, 2 package rows20240814_6c5bb008-e66f-4ef0-bf84-aca7eb5983e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSNda61463f-f87b-4aba-b538-7264252cadb8101
198013naproxen 250 MG Oral TabletSCDda61463f-f87b-4aba-b538-7264252cadb8101
198013naproxen 250 MG Oral TabletPSNe63a034d-23ef-458f-88ed-8b6d7369962123
198013naproxen 250 MG Oral TabletSCDe63a034d-23ef-458f-88ed-8b6d7369962123
198013naproxen 250 MG Oral TabletPSN6c5bb008-e66f-4ef0-bf84-aca7eb5983e913
198012naproxen 375 MG Oral TabletPSN6c5bb008-e66f-4ef0-bf84-aca7eb5983e913
198014naproxen 500 MG Oral TabletPSN6c5bb008-e66f-4ef0-bf84-aca7eb5983e913
849398naproxen sodium 275 MG Oral TabletPSN6c5bb008-e66f-4ef0-bf84-aca7eb5983e913
849431naproxen sodium 550 MG Oral TabletPSN6c5bb008-e66f-4ef0-bf84-aca7eb5983e913
198013naproxen 250 MG Oral TabletSCD6c5bb008-e66f-4ef0-bf84-aca7eb5983e913
198012naproxen 375 MG Oral TabletSCD6c5bb008-e66f-4ef0-bf84-aca7eb5983e913
198014naproxen 500 MG Oral TabletSCD6c5bb008-e66f-4ef0-bf84-aca7eb5983e913
849398naproxen sodium 275 MG Oral TabletSCD6c5bb008-e66f-4ef0-bf84-aca7eb5983e913
849431naproxen sodium 550 MG Oral TabletSCD6c5bb008-e66f-4ef0-bf84-aca7eb5983e913
849398naproxen sodium 275 MG (as naproxen 250 MG) Oral TabletSY6c5bb008-e66f-4ef0-bf84-aca7eb5983e913
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY6c5bb008-e66f-4ef0-bf84-aca7eb5983e913
198013naproxen 250 MG Oral TabletPSNc38ae25f-d73e-4f85-b450-87df87e989da4
198013naproxen 250 MG Oral TabletPSNaa4d159c-9cbe-4d29-9532-33a312f1ae054
198013naproxen 250 MG Oral TabletPSN8066fff6-a9ba-4a94-9412-7f8ef8c028e24
198014naproxen 500 MG Oral TabletPSNc38ae25f-d73e-4f85-b450-87df87e989da4
198013naproxen 250 MG Oral TabletSCD8066fff6-a9ba-4a94-9412-7f8ef8c028e24
198013naproxen 250 MG Oral TabletSCDaa4d159c-9cbe-4d29-9532-33a312f1ae054
198013naproxen 250 MG Oral TabletSCDc38ae25f-d73e-4f85-b450-87df87e989da4
198014naproxen 500 MG Oral TabletSCDc38ae25f-d73e-4f85-b450-87df87e989da4
198013naproxen 250 MG Oral TabletPSN1f7d2f11-5b62-1c90-e054-00144ff88e882
198013naproxen 250 MG Oral TabletSCD1f7d2f11-5b62-1c90-e054-00144ff88e882
198013naproxen 250 MG Oral TabletPSN1e9675c8-bcff-4621-90f7-b80489e1b8401
198013naproxen 250 MG Oral TabletPSN4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
198013naproxen 250 MG Oral TabletPSN2c4f826c-e71b-4462-a025-19730701a9de1
198012naproxen 375 MG Oral TabletPSN2c4f826c-e71b-4462-a025-19730701a9de1
198012naproxen 375 MG Oral TabletPSN4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
198014naproxen 500 MG Oral TabletPSN2c4f826c-e71b-4462-a025-19730701a9de1
198014naproxen 500 MG Oral TabletPSN4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
849398naproxen sodium 275 MG Oral TabletPSN4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
849431naproxen sodium 550 MG Oral TabletPSN4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
198013naproxen 250 MG Oral TabletSCD2c4f826c-e71b-4462-a025-19730701a9de1
198013naproxen 250 MG Oral TabletSCD4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
198013naproxen 250 MG Oral TabletSCD1e9675c8-bcff-4621-90f7-b80489e1b8401
198012naproxen 375 MG Oral TabletSCD2c4f826c-e71b-4462-a025-19730701a9de1
198012naproxen 375 MG Oral TabletSCD4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
198014naproxen 500 MG Oral TabletSCD2c4f826c-e71b-4462-a025-19730701a9de1
198014naproxen 500 MG Oral TabletSCD4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
849398naproxen sodium 275 MG Oral TabletSCD4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
849431naproxen sodium 550 MG Oral TabletSCD4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
849398naproxen sodium 275 MG (as naproxen 250 MG) Oral TabletSY4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY4bbe6e74-b13e-4609-b4cc-aa0b00d66df81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-188-0168462018801100 TABLET in 1 BOTTLE (68462-188-01) 100 tablet2007-07-010000-00-00NoNoCurrent
68462-188-0568462018805500 TABLET in 1 BOTTLE (68462-188-05) 500 tablet2007-07-010000-00-00NoNoCurrent