Naproxen

Product NDC
68151-2609
11-digit product format
681512609
Labeler code
68151
Product ID
68151-2609_b8532ccd-05a2-4f1a-8664-7d801fedf5c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA075227
Marketing category
ANDA
Marketing start
1998-07-29
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
500 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
68151-2609-02020-01-31C16284748780-19d75b9d0-fc97-f424-e053-dadaa90a57ceNaproxen Delayed-Release Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-2609-0Naproxen1 in 1 PACKAGETABLET, DELAYED RELEASE13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NAPROXEN TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JNAPROXEN TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZNAPROXEN TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NAPROXEN TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
SHELLACINACTIVE INGREDIENT46N107B71ONAPROXEN TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNAPROXEN TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMNAPROXEN TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-2609NAPROXEN TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160805_d22cabc5-c4c6-4063-877b-251a99b0560a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311915naproxen 500 MG Delayed Release Oral TabletPSNd22cabc5-c4c6-4063-877b-251a99b0560a3
311915naproxen 500 MG Delayed Release Oral TabletSCDd22cabc5-c4c6-4063-877b-251a99b0560a3
311915naproxen (as naproxen sodium) 500 MG Delayed Release Oral TabletSYd22cabc5-c4c6-4063-877b-251a99b0560a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-2609-0681512609001 in 1 PACKAGEHistorical