Naproxen

Product NDC
10544-016
11-digit product format
105440016
Labeler code
10544
Product ID
10544-016_ba7d1b7d-2922-4f13-a0d6-df49e336d10e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA075927
Marketing category
ANDA
Marketing start
2010-09-15
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
10544-016-202019-10-29C16284748780-1960f7f55-dbb0-8e05-e053-dbdaa90a074aNaproxen Tablets, USP
10544-016-302019-10-29C16284748780-1960f7f55-dbb0-8e05-e053-dbdaa90a074aNaproxen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-016-20Naproxen20 in 1 BOTTLETABLET201
10544-016-30Naproxen30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-016-20EA - Each10544-016f051b4cc-8786-4017-8af9-f6b1d3bc74f912015-10-02
10544-016-30EA - Each10544-0165aff7134-49ea-4edc-abd9-312189f5ad5412015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-016NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 2 package rows20101007_942c2438-9fe9-4f31-9617-3c6d029154d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN942c2438-9fe9-4f31-9617-3c6d029154d31
198014naproxen 500 MG Oral TabletSCD942c2438-9fe9-4f31-9617-3c6d029154d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-016-201054400162020 in 1 BOTTLEHistorical
10544-016-301054400163030 in 1 BOTTLEHistorical