FDA.reportPublic FDA data

Naproxen

Product NDC
10544-044
11-digit product format
105440044
Labeler code
10544
Product ID
10544-044_8eb3883b-e794-4d59-aa00-a870df172b97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA075927
Marketing category
ANDA
Marketing start
2011-05-04
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
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
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
10544-044-202020-01-31C16284748780-19d75b9d0-5920-f424-e053-dadaa90a57ceNaproxen Tablets, USP
10544-044-302020-01-31C16284748780-19d75b9d0-5920-f424-e053-dadaa90a57ceNaproxen Tablets, USP
10544-044-602020-01-31C16284748780-19d75b9d0-5920-f424-e053-dadaa90a57ceNaproxen Tablets, USP
10544-044-902020-01-31C16284748780-19d75b9d0-5920-f424-e053-dadaa90a57ceNaproxen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-044-20Naproxen20 in 1 BOTTLETABLET202
10544-044-30Naproxen30 in 1 BOTTLETABLET302
10544-044-60Naproxen60 in 1 BOTTLETABLET602
10544-044-90Naproxen90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-044-20EA - Each10544-0441ff1ba09-6ef3-4a19-b9ff-5362e04719d712015-05-05
10544-044-30EA - Each10544-04441ccdc04-0871-4bc3-9d1e-60e0c9a71f7512015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-044NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 4 package rows20150209_f4d9bd36-b960-47f6-afde-22f5012d419b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNf4d9bd36-b960-47f6-afde-22f5012d419b2
198014naproxen 500 MG Oral TabletSCDf4d9bd36-b960-47f6-afde-22f5012d419b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-044-201054400442020 in 1 BOTTLEHistorical
10544-044-301054400443030 in 1 BOTTLEHistorical
10544-044-601054400446060 in 1 BOTTLEHistorical
10544-044-901054400449090 in 1 BOTTLEHistorical