FDA.reportPublic FDA data

Naproxen

Product NDC
68788-7572
11-digit product format
687887572
Labeler code
68788
Product ID
68788-7572_afc77c85-efb4-4380-b745-1284d57ade68
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA204872
Marketing category
ANDA
Marketing start
2019-01-01
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
Naproxen
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
68788-7572-2Naproxen20 in 1 BOTTLETABLET207
68788-7572-3Naproxen30 in 1 BOTTLETABLET307
68788-7572-4Naproxen40 in 1 BOTTLETABLET407
68788-7572-6Naproxen60 in 1 BOTTLETABLET607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7572NAPROXEN (NAPROXEN SODIUM) TABLET [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 4 package rows20240724_20eb9d9f-11df-464f-a1b0-949f8fda4042.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN20eb9d9f-11df-464f-a1b0-949f8fda40427
849574naproxen sodium 220 MG Oral TabletSCD20eb9d9f-11df-464f-a1b0-949f8fda40427
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY20eb9d9f-11df-464f-a1b0-949f8fda40427

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7572-26878875720220 TABLET in 1 BOTTLE (68788-7572-2) 20 tablet2019-12-270000-00-00NoNoCurrent
68788-7572-36878875720330 TABLET in 1 BOTTLE (68788-7572-3) 30 tablet2019-12-270000-00-00NoNoCurrent
68788-7572-46878875720440 TABLET in 1 BOTTLE (68788-7572-4) 40 tablet2019-12-270000-00-00NoNoCurrent
68788-7572-66878875720660 TABLET in 1 BOTTLE (68788-7572-6) 60 tablet2019-12-270000-00-00NoNoCurrent