FDA.reportPublic FDA data

Good Sense Naproxen Sodium

Product NDC
0113-0901
11-digit product format
001130901
Labeler code
0113
Product ID
0113-0901_219ea0aa-ea9c-403d-b120-9d6ea99d8ea8
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
2014-04-23
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
0113-0901-62Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED18
0113-0901-62Good Sense Naproxen Sodium24 in 1 BOTTLETABLET, FILM COATED248
0113-0901-71Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED18
0113-0901-71Good Sense Naproxen Sodium50 in 1 BOTTLETABLET, FILM COATED508
0113-0901-75Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED18
0113-0901-75Good Sense Naproxen Sodium90 in 1 BOTTLETABLET, FILM COATED908
0113-0901-76Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED18
0113-0901-76Good Sense Naproxen Sodium120 in 1 BOTTLETABLET, FILM COATED1208
0113-0901-78Good Sense Naproxen Sodium100 in 1 BOTTLETABLET, FILM COATED1008
0113-0901-78Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0901-62EA - Each0113-0901df0b0a83-6ddf-4f38-9f6a-4070204c84b412018-06-11
0113-0901-71EA - Each0113-0901fd3b8fb5-2092-4940-8ec5-094a5a4f3ee212023-01-09
0113-0901-75EA - Each0113-09016e147446-0cdc-4508-b89d-6bf6bda5efe712023-09-05
0113-0901-78EA - Each0113-0901d659e4b4-48f9-4803-b782-c0ac07fd8e9912020-06-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [L. PERRIGO COMPANY]2
NAPROXENACTIVE MOIETY57Y76R9ATQGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [L. PERRIGO COMPANY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [L. PERRIGO COMPANY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [L. PERRIGO COMPANY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [L. PERRIGO COMPANY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [L. PERRIGO COMPANY]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [L. PERRIGO COMPANY]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [L. PERRIGO COMPANY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [L. PERRIGO COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0901GOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]7Current NDC, Legacy NDC, 10 package rows20240901_6bc74cda-458c-480e-a33c-d2ba68d5e6bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN6bc74cda-458c-480e-a33c-d2ba68d5e6bd8
849574naproxen sodium 220 MG Oral TabletSCD6bc74cda-458c-480e-a33c-d2ba68d5e6bd8
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY6bc74cda-458c-480e-a33c-d2ba68d5e6bd8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0901-62001130901621 BOTTLE in 1 CARTON (0113-0901-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-04-230000-00-00NoNoCurrent
0113-0901-71001130901711 BOTTLE in 1 CARTON (0113-0901-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-04-230000-00-00NoNoCurrent
0113-0901-75001130901751 BOTTLE in 1 CARTON (0113-0901-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-080000-00-00NoNoCurrent
0113-0901-76001130901761 BOTTLE in 1 CARTON (0113-0901-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-04-230000-00-00NoNoCurrent
0113-0901-78001130901781 BOTTLE in 1 CARTON (0113-0901-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2014-04-230000-00-00NoNoCurrent