naproxen sodium

Product NDC
11822-0490
11-digit product format
118220490
Labeler code
11822
Product ID
11822-0490_1d3cd8bf-240a-4214-8856-97be8d37bf42
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA074661
Marketing category
ANDA
Marketing start
2001-05-16
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [RITE AID CORPORATION]3
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [RITE AID CORPORATION]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN SODIUM TABLET [RITE AID CORPORATION]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONAPROXEN SODIUM TABLET [RITE AID CORPORATION]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [RITE AID CORPORATION]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANAPROXEN SODIUM TABLET [RITE AID CORPORATION]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [RITE AID CORPORATION]3
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN SODIUM TABLET [RITE AID CORPORATION]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN SODIUM TABLET [RITE AID CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0490NAPROXEN SODIUM TABLET, FILM COATED [RITE AID CORPORATION]7Legacy NDC20220126_1b63177f-17e5-4b5a-8924-7023efe016aa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0490-1118220490011 BOTTLE in 1 CARTON (11822-0490-1) > 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2001-05-220000-00-00NoNoCurrent
11822-0490-5118220490051 BOTTLE in 1 CARTON (11822-0490-5) > 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-290000-00-00NoNoCurrent
11822-0490-7118220490071 BOTTLE in 1 CARTON (11822-0490-7) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2001-05-160000-00-00NoNoCurrent