FDA.reportPublic FDA data

Good Sense Naproxen Sodium

Product NDC
63187-794
11-digit product format
631870794
Labeler code
63187
Product ID
63187-794_f63d2be5-56a8-4c70-b684-c210f67058ba
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Good Sense 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
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
63187-794-20Good Sense Naproxen Sodium20 in 1 BOTTLETABLET, FILM COATED202
63187-794-30Good Sense Naproxen Sodium30 in 1 BOTTLETABLET, FILM COATED302
63187-794-60Good Sense Naproxen Sodium60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-794-20EA - Each63187-794d40744b1-b0a7-4366-a41e-bc54804e0fe612017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-794GOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20191203_c0dc7f87-355c-4357-b99d-f03693d350a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNc0dc7f87-355c-4357-b99d-f03693d350a72
849574naproxen sodium 220 MG Oral TabletSCDc0dc7f87-355c-4357-b99d-f03693d350a72
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYc0dc7f87-355c-4357-b99d-f03693d350a72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-794-206318707942020 TABLET, FILM COATED in 1 BOTTLE (63187-794-20) 2016-12-010000-00-00NoNoCurrent
63187-794-306318707943030 TABLET, FILM COATED in 1 BOTTLE (63187-794-30) 2016-12-010000-00-00NoNoCurrent
63187-794-606318707946060 TABLET, FILM COATED in 1 BOTTLE (63187-794-60) 2016-12-010000-00-00NoNoCurrent