FDA.reportPublic FDA data

Good Sense Naproxen Sodium

Product NDC
0113-4368
11-digit product format
001134368
Labeler code
0113
Product ID
0113-4368_6f39afcd-64da-45f6-96d3-271c7b7a99dd
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA074661
Marketing category
ANDA
Marketing start
2014-03-31
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Good Sense Naproxen Sodium
Listing expiration
2027-12-31

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
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
0113-4368-00Good Sense Naproxen Sodium200 in 1 BOTTLETABLET, FILM COATED20010
0113-4368-62Good Sense Naproxen Sodium24 in 1 BOTTLETABLET, FILM COATED2410
0113-4368-62Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110
0113-4368-71Good Sense Naproxen Sodium50 in 1 BOTTLETABLET, FILM COATED5010
0113-4368-71Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110
0113-4368-75Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110
0113-4368-75Good Sense Naproxen Sodium90 in 1 BOTTLETABLET, FILM COATED9010
0113-4368-76Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110
0113-4368-76Good Sense Naproxen Sodium120 in 1 BOTTLETABLET, FILM COATED12010
0113-4368-78Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110
0113-4368-78Good Sense Naproxen Sodium100 in 1 BOTTLETABLET, FILM COATED10010
0113-4368-79Good Sense Naproxen Sodium400 in 1 BOTTLETABLET, FILM COATED40010
0113-4368-82Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-4368-62EA - Each0113-4368bc67d066-2a1e-4806-a7c1-e232b732e93b12018-02-20
0113-4368-71EA - Each0113-4368993338e5-109e-4ef6-9be0-b5f443412b5712018-02-20
0113-4368-76EA - Each0113-436844440010-53b4-4de7-9f66-fda678f65a3512024-02-14
0113-4368-78EA - Each0113-4368e8dafb0f-462d-4fc5-bfb9-c6567df41bbd12017-03-06
0113-4368-79EA - Each0113-43684abd9a15-8206-4d60-bf29-504433dc3b2912023-03-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3
NAPROXENACTIVE MOIETY57Y76R9ATQGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3
TALCINACTIVE INGREDIENT7SEV7J4R1UGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-4368GOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]8Current NDC, Legacy NDC, 13 package rows20240328_8e150c00-8e5b-40b4-a964-cb70442c2752.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN8e150c00-8e5b-40b4-a964-cb70442c275210
849574naproxen sodium 220 MG Oral TabletSCD8e150c00-8e5b-40b4-a964-cb70442c275210
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY8e150c00-8e5b-40b4-a964-cb70442c275210
849574naproxen sodium 220 MG Oral TabletPSN2183df53-ac90-4d43-8a5d-8421036bc4cb2
849574naproxen sodium 220 MG Oral TabletPSNc0dc7f87-355c-4357-b99d-f03693d350a72
849574naproxen sodium 220 MG Oral TabletPSNe5e8768d-c6e0-4018-b788-5ce86929f7b02
849574naproxen sodium 220 MG Oral TabletSCD2183df53-ac90-4d43-8a5d-8421036bc4cb2
849574naproxen sodium 220 MG Oral TabletSCDc0dc7f87-355c-4357-b99d-f03693d350a72
849574naproxen sodium 220 MG Oral TabletSCDe5e8768d-c6e0-4018-b788-5ce86929f7b02
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY2183df53-ac90-4d43-8a5d-8421036bc4cb2
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYc0dc7f87-355c-4357-b99d-f03693d350a72
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYe5e8768d-c6e0-4018-b788-5ce86929f7b02
849574naproxen sodium 220 MG Oral TabletPSN494db9ba-6907-497d-a150-451e12c81cb11
849574naproxen sodium 220 MG Oral TabletSCD494db9ba-6907-497d-a150-451e12c81cb11
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY494db9ba-6907-497d-a150-451e12c81cb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-4368-0000113436800200 in 1 BOTTLEHistorical
0113-4368-62001134368621 BOTTLE in 1 CARTON (0113-4368-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-03-310000-00-00NoNoCurrent
0113-4368-71001134368711 BOTTLE in 1 CARTON (0113-4368-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-03-310000-00-00NoNoCurrent
0113-4368-75001134368751 BOTTLE in 1 CARTON (0113-4368-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-080000-00-00NoNoCurrent
0113-4368-76001134368761 BOTTLE in 1 CARTON (0113-4368-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-03-310000-00-00NoNoCurrent
0113-4368-78001134368781 BOTTLE in 1 CARTON (0113-4368-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-03-310000-00-00NoNoCurrent
0113-4368-7900113436879400 TABLET, FILM COATED in 1 BOTTLE (0113-4368-79) 2018-06-190000-00-00NoNoCurrent
0113-4368-82001134368821 BOTTLE in 1 CARTON (0113-4368-82) / 200 TABLET, FILM COATED in 1 BOTTLE (0113-4368-00) 1 bottle2026-04-02NoNoCurrent