Naproxen Sodium

Product NDC
62207-753
11-digit product format
622070753
Labeler code
62207
Product ID
62207-753_7e93cb72-cb96-39f6-e053-2991aa0a367f
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Granules India Limited
Application
ANDA091353
Marketing category
ANDA
Marketing start
2011-09-30
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62207-753-41Naproxen Sodium24 in 1 BOTTLETABLET247
62207-753-42Naproxen Sodium50 in 1 BOTTLETABLET507
62207-753-43Naproxen Sodium43 in 1 BOTTLETABLET437
62207-753-44Naproxen Sodium150 in 1 BOTTLETABLET1507
62207-753-45Naproxen Sodium200 in 1 BOTTLETABLET2007
62207-753-47Naproxen Sodium500 in 1 BOTTLETABLET5007
62207-753-49Naproxen Sodium1000 in 1 BOTTLETABLET10007
62207-753-51Naproxen Sodium10 in 1 BOTTLETABLET107
62207-753-52Naproxen Sodium300 in 1 BOTTLETABLET3007
62207-753-53Naproxen Sodium400 in 1 BOTTLETABLET4007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [GRANULES INDIA LIMITED]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [GRANULES INDIA LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN SODIUM TABLET [GRANULES INDIA LIMITED]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM TABLET [GRANULES INDIA LIMITED]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONAPROXEN SODIUM TABLET [GRANULES INDIA LIMITED]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNAPROXEN SODIUM TABLET [GRANULES INDIA LIMITED]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNAPROXEN SODIUM TABLET [GRANULES INDIA LIMITED]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NAPROXEN SODIUM TABLET [GRANULES INDIA LIMITED]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNAPROXEN SODIUM TABLET [GRANULES INDIA LIMITED]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNAPROXEN SODIUM TABLET [GRANULES INDIA LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET [GRANULES INDIA LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62207-753NAPROXEN SODIUM TABLET [GRANULES INDIA LIMITED]7Legacy NDC, 10 package rows20231213_28d602d3-7f53-4575-848d-0670ea557d2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN28d602d3-7f53-4575-848d-0670ea557d2a7
849574naproxen sodium 220 MG Oral TabletSCD28d602d3-7f53-4575-848d-0670ea557d2a7
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY28d602d3-7f53-4575-848d-0670ea557d2a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
62207-753-416220707534124 in 1 BOTTLEHistorical
62207-753-426220707534250 in 1 BOTTLEHistorical
62207-753-436220707534343 in 1 BOTTLEHistorical
62207-753-4462207075344150 in 1 BOTTLEHistorical
62207-753-4562207075345200 in 1 BOTTLEHistorical
62207-753-4762207075347500 in 1 BOTTLEHistorical
62207-753-49622070753491000 in 1 BOTTLEHistorical
62207-753-516220707535110 in 1 BOTTLEHistorical
62207-753-5262207075352300 in 1 BOTTLEHistorical
62207-753-5362207075353400 in 1 BOTTLEHistorical