FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
17856-0194
11-digit product format
178560194
Labeler code
17856
Product ID
17856-0194_9cd0086c-fa5c-48b5-a58f-afa04e737070
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Atlantic Biologicals Corps
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],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
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
17856-0194-22020-01-31C16284748780-19d75b9cf-f2c9-f424-e053-dadaa90a57ceNaproxen Sodium Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0194-2Naproxen Sodium1 in 1 POUCHTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0194-2EA - Each17856-0194f3bfc870-e3e8-4eab-bd90-3023ddcd8bc212015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0194NAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]3Legacy NDC, 1 package rows20160303_82e83f79-3717-4469-8bc8-aea07a7f62b9.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 TabletSCD82e83f79-3717-4469-8bc8-aea07a7f62b93
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY82e83f79-3717-4469-8bc8-aea07a7f62b93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
17856-0194-2178560194021 in 1 POUCHHistorical