FDA.reportPublic FDA data

up and up naproxen sodium

Product NDC
11673-368
11-digit product format
116730368
Labeler code
11673
Product ID
11673-368_25a249be-b52a-4d7e-8352-8e6d30f3664f
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Target Corporation
Application
ANDA074661
Marketing category
ANDA
Marketing start
2009-06-24
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
up and up naproxen sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-368-71up and up naproxen sodium1 in 1 CARTONTABLET, FILM COATED111
11673-368-71up and up naproxen sodium50 in 1 BOTTLETABLET, FILM COATED5011
11673-368-76up and up naproxen sodium1 in 1 CARTONTABLET, FILM COATED111
11673-368-76up and up naproxen sodium120 in 1 BOTTLETABLET, FILM COATED12011
11673-368-78up and up naproxen sodium1 in 1 CARTONTABLET, FILM COATED111
11673-368-78up and up naproxen sodium100 in 1 BOTTLETABLET, FILM COATED10011
11673-368-82up and up naproxen sodium200 in 1 BOTTLETABLET, FILM COATED20011
11673-368-82up and up naproxen sodium1 in 1 CARTONTABLET, FILM COATED111
11673-368-87up and up naproxen sodium300 in 1 BOTTLETABLET, FILM COATED30011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11673-368-71EA - Each11673-368e4add1d5-bd3e-4015-b17a-99f24f07357d12012-07-24
11673-368-78EA - Each11673-3684206d8e2-6c59-4264-97fc-777625e9a83912012-07-24
11673-368-82EA - Each11673-368cf94fe9c-0142-4c38-b7f4-51a7ef436f3512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CUP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]5
NAPROXENACTIVE MOIETY57Y76R9ATQUP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UUP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOUP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30UP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AUP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EUP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]5
TALCINACTIVE INGREDIENT7SEV7J4R1UUP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPUP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-368UP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]10Current NDC, Legacy NDC, 9 package rows20250101_00bd8490-f280-4336-b13d-0e11c0bf4586.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN00bd8490-f280-4336-b13d-0e11c0bf458611
849574naproxen sodium 220 MG Oral TabletSCD00bd8490-f280-4336-b13d-0e11c0bf458611
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY00bd8490-f280-4336-b13d-0e11c0bf458611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-368-71116730368711 BOTTLE in 1 CARTON (11673-368-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-07-140000-00-00NoNoCurrent
11673-368-76116730368761 BOTTLE in 1 CARTON (11673-368-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2011-11-170000-00-00NoNoCurrent
11673-368-78116730368781 BOTTLE in 1 CARTON (11673-368-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-06-240000-00-00NoNoCurrent
11673-368-82116730368821 BOTTLE in 1 CARTON (11673-368-82) > 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-06-240000-00-00NoNoCurrent
11673-368-8711673036887300 TABLET, FILM COATED in 1 BOTTLE (11673-368-87) 2010-03-110000-00-00NoNoCurrent