FDA.reportPublic FDA data

Naproxen

Product NDC
0093-1006
11-digit product format
000931006
Labeler code
0093
Product ID
0093-1006_7adf6304-d32e-4642-94dc-5f2d906b9a27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
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],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-1006-01EA - Each0093-1006849c6ae5-9913-4ed8-8d97-6e6d9788bc4712012-07-24
0093-1006-05EA - Each0093-1006d4ae07a5-f814-4b81-97f9-40384a11205f12012-07-24

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
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET, DELAYED RELEASE [STAT RX USA LLC]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET, DELAYED RELEASE [STAT RX USA LLC]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET, DELAYED RELEASE [STAT RX USA LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN TABLET, DELAYED RELEASE [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET, DELAYED RELEASE [STAT RX USA LLC]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JNAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JNAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JNAPROXEN TABLET, DELAYED RELEASE [STAT RX USA LLC]1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZNAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZNAPROXEN TABLET, DELAYED RELEASE [STAT RX USA LLC]1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZNAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71ONAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNAPROXEN TABLET, DELAYED RELEASE [STAT RX USA LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN TABLET, DELAYED RELEASE [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN TABLET, DELAYED RELEASE [STAT RX USA LLC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMNAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMNAPROXEN TABLET, DELAYED RELEASE [STAT RX USA LLC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMNAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1

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
603103naproxen 375 MG Delayed Release Oral TabletPSN14e4b008-ae31-4b40-a227-1445367e09ed1
311915naproxen 500 MG Delayed Release Oral TabletPSN14e4b008-ae31-4b40-a227-1445367e09ed1
311915naproxen 500 MG Delayed Release Oral TabletPSNd2cf1ee5-df93-4d3f-a79d-d04b0426e3f21
311915naproxen 500 MG Delayed Release Oral TabletPSN7dc9f5d6-9bde-018b-e053-2a91aa0a31381
311915naproxen 500 MG Delayed Release Oral TabletPSNcce0199c-40e9-4c8c-b04c-c2b969e9a5ba1
603103naproxen 375 MG Delayed Release Oral TabletSCD14e4b008-ae31-4b40-a227-1445367e09ed1
311915naproxen 500 MG Delayed Release Oral TabletSCD14e4b008-ae31-4b40-a227-1445367e09ed1
311915naproxen 500 MG Delayed Release Oral TabletSCDd2cf1ee5-df93-4d3f-a79d-d04b0426e3f21
311915naproxen 500 MG Delayed Release Oral TabletSCD7dc9f5d6-9bde-018b-e053-2a91aa0a31381
311915naproxen 500 MG Delayed Release Oral TabletSCDcce0199c-40e9-4c8c-b04c-c2b969e9a5ba1
311915naproxen (as naproxen sodium) 500 MG Delayed Release Oral TabletSYd2cf1ee5-df93-4d3f-a79d-d04b0426e3f21
311915naproxen (as naproxen sodium) 500 MG Delayed Release Oral TabletSYcce0199c-40e9-4c8c-b04c-c2b969e9a5ba1
311915naproxen (as naproxen sodium) 500 MG Delayed Release Oral TabletSY7dc9f5d6-9bde-018b-e053-2a91aa0a31381
311915naproxen (as naproxen sodium) 500 MG Delayed Release Oral TabletSY14e4b008-ae31-4b40-a227-1445367e09ed1
603103naproxen 375 MG (as naproxen sodium 413 MG) Delayed Release Oral TabletSY14e4b008-ae31-4b40-a227-1445367e09ed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-1006-0100093100601100 TABLET, DELAYED RELEASE in 1 BOTTLE (0093-1006-01) 1998-07-290000-00-00NoNoCurrent
0093-1006-0500093100605500 TABLET, DELAYED RELEASE in 1 BOTTLE (0093-1006-05) 1998-07-290000-00-00NoNoCurrent