Naproxen Sodium

Product NDC
53746-194
11-digit product format
537460194
Labeler code
53746
Product ID
53746-194_58c84756-9886-4cfa-937c-f8894064c606
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA078432
Marketing category
ANDA
Marketing start
2007-04-26
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
2023-12-31
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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-194-01EA - Each53746-194e4b1b490-7773-4944-b6c8-83b12b4ca8d112012-07-24
53746-194-05EA - Each53746-1941d1c3c7f-1be6-479a-b0b0-63fcc373253712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [RXCHANGE CO.]2
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]2
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [RXCHANGE CO.]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM TABLET [RXCHANGE CO.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM TABLET [RXCHANGE CO.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [RXCHANGE CO.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NAPROXEN SODIUM TABLET [RXCHANGE CO.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [RXCHANGE CO.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET [RXCHANGE CO.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET [RXCHANGE CO.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]2
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM CAPSULE [DIRECT RX]1
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM CAPSULE [DIRECT RX]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM CAPSULE [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM CAPSULE [DIRECT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABNAPROXEN SODIUM CAPSULE [DIRECT RX]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NAPROXEN SODIUM CAPSULE [DIRECT RX]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM CAPSULE [DIRECT RX]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM CAPSULE [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM CAPSULE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-194NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]26Legacy NDC20241218_3c55594c-7801-4f59-8f4f-e85a03f3776b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSN82e83f79-3717-4469-8bc8-aea07a7f62b93
849431naproxen sodium 550 MG Oral TabletPSN16705fc3-5379-4557-94b6-fc5bfbbbc6d13
849431naproxen sodium 550 MG Oral TabletSCD82e83f79-3717-4469-8bc8-aea07a7f62b93
849431naproxen sodium 550 MG Oral TabletSCD16705fc3-5379-4557-94b6-fc5bfbbbc6d13
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY82e83f79-3717-4469-8bc8-aea07a7f62b93
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY16705fc3-5379-4557-94b6-fc5bfbbbc6d13
849431naproxen sodium 550 MG Oral TabletPSNab88c208-6178-41cf-a6f1-88063e340f392
849431naproxen sodium 550 MG Oral TabletSCDab88c208-6178-41cf-a6f1-88063e340f392
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSYab88c208-6178-41cf-a6f1-88063e340f392
849398naproxen sodium 275 MG Oral TabletPSN30cc16cd-720d-4baa-8941-bfdc28b62b041
849431naproxen sodium 550 MG Oral TabletPSNb91552c0-7de3-4a7a-902b-691eb7ca518b1
849431naproxen sodium 550 MG Oral TabletPSN30cc16cd-720d-4baa-8941-bfdc28b62b041
849431naproxen sodium 550 MG Oral TabletPSN0fc2f04c-43a0-4831-b499-369f06a4106a1
849431naproxen sodium 550 MG Oral TabletPSN0c01cb34-0d6b-4248-afde-82d4d934dabd1
849431naproxen sodium 550 MG Oral TabletPSN7164427d-38b4-6aae-e053-2995a90a0d071
849398naproxen sodium 275 MG Oral TabletSCD30cc16cd-720d-4baa-8941-bfdc28b62b041
849431naproxen sodium 550 MG Oral TabletSCDb91552c0-7de3-4a7a-902b-691eb7ca518b1
849431naproxen sodium 550 MG Oral TabletSCD7164427d-38b4-6aae-e053-2995a90a0d071
849431naproxen sodium 550 MG Oral TabletSCD0c01cb34-0d6b-4248-afde-82d4d934dabd1
849431naproxen sodium 550 MG Oral TabletSCD30cc16cd-720d-4baa-8941-bfdc28b62b041
849431naproxen sodium 550 MG Oral TabletSCD0fc2f04c-43a0-4831-b499-369f06a4106a1
849398naproxen sodium 275 MG (as naproxen 250 MG) Oral TabletSY30cc16cd-720d-4baa-8941-bfdc28b62b041
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSYb91552c0-7de3-4a7a-902b-691eb7ca518b1
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY30cc16cd-720d-4baa-8941-bfdc28b62b041
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY7164427d-38b4-6aae-e053-2995a90a0d071
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY0fc2f04c-43a0-4831-b499-369f06a4106a1
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY0c01cb34-0d6b-4248-afde-82d4d934dabd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-194-0153746019401100 TABLET in 1 BOTTLE (53746-194-01) 100 tablet2007-04-260000-00-00NoNoCurrent
53746-194-0553746019405500 TABLET in 1 BOTTLE (53746-194-05) 500 tablet2007-04-260000-00-00NoNoCurrent