FDA.reportPublic FDA data

good sense naproxen sodium

Product NDC
0113-1412
11-digit product format
001131412
Labeler code
0113
Product ID
0113-1412_753f4ee3-27df-4527-8445-ef6f6709d7ac
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
2021-11-09
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
0113-1412-71good sense naproxen sodium1 in 1 CARTONTABLET, FILM COATED12
0113-1412-71good sense naproxen sodium50 in 1 BOTTLETABLET, FILM COATED502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-1412-71EA - Each0113-1412f727835f-34eb-440e-bcb8-657a9ac3be3512024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-1412GOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]2Current NDC, Legacy NDC, 2 package rows20240413_a980b939-f74d-4e95-87a8-65ad5a783ac5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNa980b939-f74d-4e95-87a8-65ad5a783ac52
849574naproxen sodium 220 MG Oral TabletSCDa980b939-f74d-4e95-87a8-65ad5a783ac52
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYa980b939-f74d-4e95-87a8-65ad5a783ac52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-1412-71001131412711 BOTTLE in 1 CARTON (0113-1412-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-11-090000-00-00NoNoCurrent