FDA.reportPublic FDA data

Naproxen Pain Relief

Product NDC
21695-088
11-digit product format
216950088
Labeler code
21695
Product ID
21695-088_456815fd-1e98-43fa-8f20-47cc3b8a15bd
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA074661
Marketing category
ANDA
Marketing start
1998-03-12
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-088-142019-09-24C16284748780-1934fe258-4815-48b1-e053-8cdaa90a720aNaproxen Drug Facts
21695-088-302019-09-24C16284748780-1934fe258-4815-48b1-e053-8cdaa90a720aNaproxen Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-088-14Naproxen Pain Relief14 in 1 BOTTLETABLET141
21695-088-30Naproxen Pain Relief30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-088-14EA - Each21695-08805eb5970-0a32-4cd5-a561-5602ee7271cb12012-07-24
21695-088-30EA - Each21695-088ae66377c-b4d0-403b-ab41-077d2c57e09f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN PAIN RELIEF (NAPROXEN SODIUM) TABLET [REBEL DISTRIBUTORS CORP]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN PAIN RELIEF (NAPROXEN SODIUM) TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN PAIN RELIEF (NAPROXEN SODIUM) TABLET [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN PAIN RELIEF (NAPROXEN SODIUM) TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONAPROXEN PAIN RELIEF (NAPROXEN SODIUM) TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN PAIN RELIEF (NAPROXEN SODIUM) TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ANAPROXEN PAIN RELIEF (NAPROXEN SODIUM) TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN PAIN RELIEF (NAPROXEN SODIUM) TABLET [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN PAIN RELIEF (NAPROXEN SODIUM) TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN PAIN RELIEF (NAPROXEN SODIUM) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-088NAPROXEN PAIN RELIEF (NAPROXEN SODIUM) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110328_456815fd-1e98-43fa-8f20-47cc3b8a15bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN456815fd-1e98-43fa-8f20-47cc3b8a15bd1
849574naproxen sodium 220 MG Oral TabletSCD456815fd-1e98-43fa-8f20-47cc3b8a15bd1
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY456815fd-1e98-43fa-8f20-47cc3b8a15bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-088-142169500881414 in 1 BOTTLEHistorical
21695-088-302169500883030 in 1 BOTTLEHistorical