FDA.reportPublic FDA data

NAPROXEN SODIUM

Product NDC
61919-165
11-digit product format
619190165
Labeler code
61919
Product ID
61919-165_9ca99dc1-7125-65e1-e053-2a95a90a0be3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078432
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
550 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
61919-165-602023-01-30C16284748780-1f386c64a-1cb2-0266-e053-dadaa90a7c1aNAPROXEN SODIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-165-60NAPROXEN SODIUM60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-165-60EA - Each61919-165638a32f3-d141-47e2-a4d6-db5ba546b62f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM CAPSULE [DIRECT RX]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM CAPSULE [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM CAPSULE [DIRECT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM CAPSULE [DIRECT RX]1
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABNAPROXEN SODIUM CAPSULE [DIRECT RX]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NAPROXEN SODIUM CAPSULE [DIRECT RX]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM CAPSULE [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM CAPSULE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM CAPSULE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-165NAPROXEN SODIUM TABLET [DIRECT RX]3Legacy NDC, 1 package rows20200130_16705fc3-5379-4557-94b6-fc5bfbbbc6d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSN16705fc3-5379-4557-94b6-fc5bfbbbc6d13
849431naproxen sodium 550 MG Oral TabletSCD16705fc3-5379-4557-94b6-fc5bfbbbc6d13
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY16705fc3-5379-4557-94b6-fc5bfbbbc6d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-165-606191901656060 TABLET in 1 BOTTLE (61919-165-60) 60 tablet2014-01-010000-00-00NoNoCurrent