Naproxen

Product NDC
31722-342
11-digit product format
317220342
Labeler code
31722
Product ID
31722-342_3466d710-2b9c-402a-9a88-a15411c974ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals
Application
ANDA091305
Marketing category
ANDA
Marketing start
2012-01-23
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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-342-01EA - Each31722-342985e3d05-aaab-4fb1-a08e-08608cdd8ce512012-07-24
31722-342-05EA - Each31722-342bff54d3a-d4b3-408a-ad96-f3763180cf6712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [DIRECTRX]2
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [DIRECTRX]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [DIRECTRX]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNAPROXEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNAPROXEN TABLET [DIRECTRX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [DIRECTRX]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [DIRECTRX]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN TABLET [DIRECTRX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [CAMBER PHARMACEUTICALS]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [CAMBER PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [CAMBER PHARMACEUTICALS]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NAPROXEN TABLET [CAMBER PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNAPROXEN TABLET [CAMBER PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [CAMBER PHARMACEUTICALS]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [CAMBER PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN TABLET [CAMBER PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-342NAPROXEN TABLET [CAMBER PHARMACEUTICALS]1Legacy NDC20120201_8dd7fade-d750-49ce-b798-a1d3615e57b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN50c696da-0ea6-4d76-b50e-fb0b55ff77ae4
198014naproxen 500 MG Oral TabletSCD50c696da-0ea6-4d76-b50e-fb0b55ff77ae4
198014naproxen 500 MG Oral TabletPSN1a374a88-934a-5e61-e054-00144ff88e883
198014naproxen 500 MG Oral TabletSCD1a374a88-934a-5e61-e054-00144ff88e883
198014naproxen 500 MG Oral TabletPSNfed6b90f-9a64-49ee-aab8-3936f54358562
198014naproxen 500 MG Oral TabletSCDfed6b90f-9a64-49ee-aab8-3936f54358562