NAPROXEN

Product NDC
0143-9908
11-digit product format
001439908
Labeler code
0143
Product ID
0143-9908_9dee0114-306a-44d3-9b05-e8b033ca24f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naproxen sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
West-Ward Pharmaceuticals Corp
Application
ANDA074480
Marketing category
ANDA
Marketing start
1996-05-14
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
550 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9908-01EA - Each0143-9908aa4323bc-912b-4d54-ab76-5e64a9ae3d1b12013-05-02
0143-9908-05EA - Each0143-99089f2f46ee-7d5a-4bc7-9d4c-9f4e5d96811212013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [STAT RX USA LLC]1
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN (NAPROXEN SODIUM) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN (NAPROXEN SODIUM) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN (NAPROXEN SODIUM) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN SODIUM TABLET [STAT RX USA LLC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN SODIUM TABLET [STAT RX USA LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN (NAPROXEN SODIUM) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM TABLET [STAT RX USA LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONAPROXEN (NAPROXEN SODIUM) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNAPROXEN (NAPROXEN SODIUM) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNAPROXEN SODIUM TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN (NAPROXEN SODIUM) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [STAT RX USA LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [STAT RX USA LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNAPROXEN (NAPROXEN SODIUM) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN (NAPROXEN SODIUM) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNAPROXEN SODIUM TABLET [STAT RX USA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNAPROXEN (NAPROXEN SODIUM) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN (NAPROXEN SODIUM) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN (NAPROXEN SODIUM) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSN11b938f8-f1de-4d63-e054-00144ff88e881
849431naproxen sodium 550 MG Oral TabletPSN926971f1-dcff-4e9e-9ee3-35eb224027161
849431naproxen sodium 550 MG Oral TabletSCD11b938f8-f1de-4d63-e054-00144ff88e881
849431naproxen sodium 550 MG Oral TabletSCD926971f1-dcff-4e9e-9ee3-35eb224027161
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY11b938f8-f1de-4d63-e054-00144ff88e881
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY926971f1-dcff-4e9e-9ee3-35eb224027161