FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
63868-466
11-digit product format
638680466
Labeler code
63868
Product ID
63868-466_459b1f3a-7730-da84-e063-6294a90ad9c5
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
ANDA079096
Marketing category
ANDA
Marketing start
2009-06-19
Marketing end
2028-01-31
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574

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
63868-466-01Naproxen Sodium100 in 1 BOTTLE, PLASTICTABLET, COATED1004
63868-466-01Naproxen Sodium1 in 1 CARTONTABLET, COATED14
63868-466-25Naproxen Sodium1 in 1 CARTONTABLET, COATED14
63868-466-25Naproxen Sodium24 in 1 BOTTLE, PLASTICTABLET, COATED244
63868-466-50Naproxen Sodium50 in 1 BOTTLE, PLASTICTABLET, COATED504
63868-466-50Naproxen Sodium1 in 1 CARTONTABLET, COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-466-01EA - Each63868-46662fd4e1c-2b7f-4fbd-af11-c820026a9c2e12022-09-12
63868-466-25EA - Each63868-466545eca9a-239e-4d71-b91b-13fa9b403add12022-10-06
63868-466-50EA - Each63868-46669d60864-751e-4747-a908-26b9d1b95c4a12022-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-466NAPROXEN SODIUM TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION]3Current NDC, Legacy NDC, 6 package rows20241208_2ee83008-c012-48d6-9479-65e7d6f50f4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN2ee83008-c012-48d6-9479-65e7d6f50f4c4
849574naproxen sodium 220 MG Oral TabletSCD2ee83008-c012-48d6-9479-65e7d6f50f4c4
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY2ee83008-c012-48d6-9479-65e7d6f50f4c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-466-01638680466011 BOTTLE, PLASTIC in 1 CARTON (63868-466-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2009-06-192028-01-31NoNoCurrent
63868-466-25638680466251 BOTTLE, PLASTIC in 1 CARTON (63868-466-25) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2013-05-022027-09-30NoNoCurrent
63868-466-50638680466501 BOTTLE, PLASTIC in 1 CARTON (63868-466-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2009-06-192027-09-30NoNoCurrent