FDA.reportPublic FDA data

Naproxen

Product NDC
10544-920
11-digit product format
105440920
Labeler code
10544
Product ID
10544-920_17c8f200-7f6f-6e6b-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA091432
Marketing category
ANDA
Marketing start
2015-06-04
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
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
10544-920-302020-01-31C16284748780-19d75b9d0-7120-f424-e053-dadaa90a57ceNaproxen Delayed-release Tablets USP, 375 mg and 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-920-30Naproxendelayed release30 in 1 BOTTLETABLET302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-920NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 1 package rows20150605_17c8f200-7f6e-6e6b-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311915naproxen 500 MG Delayed Release Oral TabletPSN17c8f200-7f6e-6e6b-e054-00144ff88e882
311915naproxen 500 MG Delayed Release Oral TabletSCD17c8f200-7f6e-6e6b-e054-00144ff88e882
311915naproxen (as naproxen sodium) 500 MG Delayed Release Oral TabletSY17c8f200-7f6e-6e6b-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-920-301054409203030 in 1 BOTTLEHistorical