FDA.reportPublic FDA data

Naproxen

Product NDC
10544-278
11-digit product format
105440278
Labeler code
10544
Product ID
10544-278_8f1f748d-b9e7-4b2c-a778-ee36ff4712d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA078250
Marketing category
ANDA
Marketing start
2010-03-17
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
10544-278-142019-10-21C16284748780-1956f9ecf-d005-621f-e053-dbdaa90a74adNaproxen Tablets USP Naproxen Sodium Tablets USP
10544-278-202019-10-21C16284748780-1956f9ecf-d005-621f-e053-dbdaa90a74adNaproxen Tablets USP Naproxen Sodium Tablets USP
10544-278-302019-10-21C16284748780-1956f9ecf-d005-621f-e053-dbdaa90a74adNaproxen Tablets USP Naproxen Sodium Tablets USP
10544-278-602019-10-21C16284748780-1956f9ecf-d005-621f-e053-dbdaa90a74adNaproxen Tablets USP Naproxen Sodium Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-278-14Naproxen14 in 1 BOTTLETABLET142
10544-278-20Naproxen20 in 1 BOTTLETABLET202
10544-278-30Naproxen30 in 1 BOTTLETABLET302
10544-278-60Naproxen60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-278-20EA - Each10544-2782f6fb444-9555-4e8a-bff3-4e90d077bead12015-02-02
10544-278-30EA - Each10544-278e2543420-f5db-4807-99a2-4b52d3aac2b612015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-278NAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 4 package rows20100422_50954ade-19ad-40dd-8e06-0b33394895f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198012naproxen 375 MG Oral TabletPSN50954ade-19ad-40dd-8e06-0b33394895f72
198014naproxen 500 MG Oral TabletPSN50954ade-19ad-40dd-8e06-0b33394895f72
849398naproxen sodium 275 MG Oral TabletPSN50954ade-19ad-40dd-8e06-0b33394895f72
849431naproxen sodium 550 MG Oral TabletPSN50954ade-19ad-40dd-8e06-0b33394895f72
198012naproxen 375 MG Oral TabletSCD50954ade-19ad-40dd-8e06-0b33394895f72
198014naproxen 500 MG Oral TabletSCD50954ade-19ad-40dd-8e06-0b33394895f72
849398naproxen sodium 275 MG Oral TabletSCD50954ade-19ad-40dd-8e06-0b33394895f72
849431naproxen sodium 550 MG Oral TabletSCD50954ade-19ad-40dd-8e06-0b33394895f72
849398naproxen sodium 275 MG (as naproxen 250 MG) Oral TabletSY50954ade-19ad-40dd-8e06-0b33394895f72
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY50954ade-19ad-40dd-8e06-0b33394895f72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-278-141054402781414 in 1 BOTTLEHistorical
10544-278-201054402782020 in 1 BOTTLEHistorical
10544-278-301054402783030 in 1 BOTTLEHistorical
10544-278-601054402786060 in 1 BOTTLEHistorical