FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
68462-179
11-digit product format
684620179
Labeler code
68462
Product ID
68462-179_16372549-a419-4920-a200-5128017570ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA078314
Marketing category
ANDA
Marketing start
2007-08-01
Substance
NAPROXEN SODIUM
Active strength
550 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 SODIUM550 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C, 57Y76R9ATQ
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
68462-179-01Naproxen Sodium100 in 1 BOTTLETABLET10013
68462-179-05Naproxen Sodium500 in 1 BOTTLETABLET50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-179-01EA - Each68462-179bb1dd364-88b9-46a2-b674-4b928187e42512012-07-24
68462-179-05EA - Each68462-17981b8bab5-7fa3-46b0-a303-47760370eb6212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Naproxen SodiumACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM (NAPROXEN) TABLET [H.J. HARKINS COMPANY, INC.]5
NaproxenACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM (NAPROXEN) TABLET [H.J. HARKINS COMPANY, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN SODIUM (NAPROXEN) TABLET [H.J. HARKINS COMPANY, INC.]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN SODIUM (NAPROXEN) TABLET [H.J. HARKINS COMPANY, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM (NAPROXEN) TABLET [H.J. HARKINS COMPANY, INC.]5
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM (NAPROXEN) TABLET [H.J. HARKINS COMPANY, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM (NAPROXEN) TABLET [H.J. HARKINS COMPANY, INC.]5
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 [STAT RX USA LLC]3
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN TABLET NAPROXEN SODIUM TABLET [STAT RX USA LLC]3
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]3
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET NAPROXEN SODIUM TABLET [STAT RX USA LLC]3
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN TABLET NAPROXEN SODIUM TABLET [STAT RX USA LLC]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN TABLET NAPROXEN SODIUM TABLET [STAT RX USA LLC]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET NAPROXEN SODIUM TABLET [STAT RX USA LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET NAPROXEN SODIUM TABLET [STAT RX USA LLC]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET NAPROXEN SODIUM TABLET [STAT RX USA LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN TABLET NAPROXEN SODIUM TABLET [STAT RX USA LLC]3
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]1
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]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
68462-179NAPROXEN 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
198012naproxen 375 MG Oral TabletPSN9d28422f-6f25-4f14-9272-e0907c971f3335
198014naproxen 500 MG Oral TabletPSN9d28422f-6f25-4f14-9272-e0907c971f3335
849431naproxen sodium 550 MG Oral TabletPSN9d28422f-6f25-4f14-9272-e0907c971f3335
198012naproxen 375 MG Oral TabletSCD9d28422f-6f25-4f14-9272-e0907c971f3335
198014naproxen 500 MG Oral TabletSCD9d28422f-6f25-4f14-9272-e0907c971f3335
849431naproxen sodium 550 MG Oral TabletSCD9d28422f-6f25-4f14-9272-e0907c971f3335
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY9d28422f-6f25-4f14-9272-e0907c971f3335
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
849431naproxen sodium 550 MG Oral TabletPSN96ef2f48-d478-478c-95d0-1c0b986493d15
849431naproxen sodium 550 MG Oral TabletSCD96ef2f48-d478-478c-95d0-1c0b986493d15
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY96ef2f48-d478-478c-95d0-1c0b986493d15
198014naproxen 500 MG Oral TabletPSNa671b0fb-6b6b-43e7-994b-5de54582c4a73
849398naproxen sodium 275 MG Oral TabletPSN577b9f26-ab59-4b15-a26a-465f0d255bad3
849431naproxen sodium 550 MG Oral TabletPSN577b9f26-ab59-4b15-a26a-465f0d255bad3
849431naproxen sodium 550 MG Oral TabletPSNa671b0fb-6b6b-43e7-994b-5de54582c4a73
198014naproxen 500 MG Oral TabletSCDa671b0fb-6b6b-43e7-994b-5de54582c4a73
849398naproxen sodium 275 MG Oral TabletSCD577b9f26-ab59-4b15-a26a-465f0d255bad3
849431naproxen sodium 550 MG Oral TabletSCD577b9f26-ab59-4b15-a26a-465f0d255bad3
849431naproxen sodium 550 MG Oral TabletSCDa671b0fb-6b6b-43e7-994b-5de54582c4a73
849398naproxen sodium 275 MG (as naproxen 250 MG) Oral TabletSY577b9f26-ab59-4b15-a26a-465f0d255bad3
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY577b9f26-ab59-4b15-a26a-465f0d255bad3
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSYa671b0fb-6b6b-43e7-994b-5de54582c4a73
849438Anaprox DS 550 MG Oral TabletPSN3784e189-f431-54d2-e054-00144ff8d46c2
198012naproxen 375 MG Oral TabletPSN50954ade-19ad-40dd-8e06-0b33394895f72
198014naproxen 500 MG Oral TabletPSN50954ade-19ad-40dd-8e06-0b33394895f72
849398naproxen sodium 275 MG Oral TabletPSN50954ade-19ad-40dd-8e06-0b33394895f72
849431naproxen sodium 550 MG Oral TabletPSN3784e189-f431-54d2-e054-00144ff8d46c2
849431naproxen sodium 550 MG Oral TabletPSN36996557-3227-b753-e063-6394a90a7b6f2
849431naproxen sodium 550 MG Oral TabletPSN50954ade-19ad-40dd-8e06-0b33394895f72
849438naproxen sodium 550 MG Oral Tablet [Anaprox]SBD3784e189-f431-54d2-e054-00144ff8d46c2
198012naproxen 375 MG Oral TabletSCD50954ade-19ad-40dd-8e06-0b33394895f72
198014naproxen 500 MG Oral TabletSCD50954ade-19ad-40dd-8e06-0b33394895f72
849398naproxen sodium 275 MG Oral TabletSCD50954ade-19ad-40dd-8e06-0b33394895f72
849431naproxen sodium 550 MG Oral TabletSCD36996557-3227-b753-e063-6394a90a7b6f2
849431naproxen sodium 550 MG Oral TabletSCD50954ade-19ad-40dd-8e06-0b33394895f72
849431naproxen sodium 550 MG Oral TabletSCD3784e189-f431-54d2-e054-00144ff8d46c2
849438Anaprox 550 MG Oral TabletSY3784e189-f431-54d2-e054-00144ff8d46c2
849438Anaprox DS 550 MG Oral TabletSY3784e189-f431-54d2-e054-00144ff8d46c2
849398naproxen sodium 275 MG (as naproxen 250 MG) Oral TabletSY50954ade-19ad-40dd-8e06-0b33394895f72
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY36996557-3227-b753-e063-6394a90a7b6f2
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY3784e189-f431-54d2-e054-00144ff8d46c2
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY50954ade-19ad-40dd-8e06-0b33394895f72
198013naproxen 250 MG Oral TabletPSN4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
198012naproxen 375 MG Oral TabletPSN4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
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
849431naproxen sodium 550 MG Oral TabletPSN83dd8829-7ba0-4a8d-a979-41a5e077c49f1
198013naproxen 250 MG Oral TabletSCD4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
198012naproxen 375 MG Oral TabletSCD4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
198014naproxen 500 MG Oral TabletSCD4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
849398naproxen sodium 275 MG Oral TabletSCD4bbe6e74-b13e-4609-b4cc-aa0b00d66df81
849431naproxen sodium 550 MG Oral TabletSCD83dd8829-7ba0-4a8d-a979-41a5e077c49f1
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 TabletSY83dd8829-7ba0-4a8d-a979-41a5e077c49f1
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
68462-179-0168462017901100 TABLET in 1 BOTTLE (68462-179-01) 100 tablet2007-08-010000-00-00NoNoCurrent
68462-179-0568462017905500 TABLET in 1 BOTTLE (68462-179-05) 500 tablet2007-08-010000-00-00NoNoCurrent