FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
68387-545
11-digit product format
683870545
Labeler code
68387
Product ID
68387-545_f3d225b4-4057-4b9d-b560-d8d3357f9561
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Keltman Pharmaceuticals Inc.
Application
ANDA078432
Marketing category
ANDA
Marketing start
2010-12-10
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
550 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
2017-12-31
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
68387-545-302019-10-29C16284748780-1960f7f55-cf38-8e05-e053-dbdaa90a074aNaproxen Sodium Tablets
68387-545-602019-10-29C16284748780-1960f7f55-cf38-8e05-e053-dbdaa90a074aNaproxen Sodium Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-545-30Naproxen Sodium30 in 1 BOTTLE, PLASTICTABLET301
68387-545-60Naproxen Sodium60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-545-30EA - Each68387-54576309528-daa5-43fa-8044-da0bd81fdebb12012-07-24
68387-545-60EA - Each68387-545d6ad82a4-4d0a-4326-8f91-3d769216b93312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-545NAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]1Legacy NDC, 2 package rows20101214_0fc2f04c-43a0-4831-b499-369f06a4106a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSN0fc2f04c-43a0-4831-b499-369f06a4106a1
849431naproxen sodium 550 MG Oral TabletSCD0fc2f04c-43a0-4831-b499-369f06a4106a1
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY0fc2f04c-43a0-4831-b499-369f06a4106a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68387-545-306838705453030 in 1 BOTTLE, PLASTICHistorical
68387-545-606838705456060 in 1 BOTTLE, PLASTICHistorical