FDA.reportPublic FDA data

Naproxen

Product NDC
68788-7946
11-digit product format
687887946
Labeler code
68788
Product ID
68788-7946_2d1cb1b6-3ef0-48e8-81a4-86e23528d55a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA212517
Marketing category
ANDA
Marketing start
2021-06-28
Substance
NAPROXEN
Active strength
375 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
NAPROXEN375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198012

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
68788-7946-1Naproxen100 in 1 BOTTLETABLET1005
68788-7946-2Naproxen20 in 1 BOTTLETABLET205
68788-7946-3Naproxen30 in 1 BOTTLETABLET305
68788-7946-6Naproxen60 in 1 BOTTLETABLET605
68788-7946-8Naproxen120 in 1 BOTTLETABLET1205
68788-7946-9Naproxen90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7946NAPROXEN TABLET [PREFERRED PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 6 package rows20240724_9f026fd5-f996-4383-b528-841d38d3dab5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198012naproxen 375 MG Oral TabletPSN9f026fd5-f996-4383-b528-841d38d3dab55
198012naproxen 375 MG Oral TabletSCD9f026fd5-f996-4383-b528-841d38d3dab55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7946-168788794601100 TABLET in 1 BOTTLE (68788-7946-1) 100 tablet2021-06-280000-00-00NoNoCurrent
68788-7946-26878879460220 TABLET in 1 BOTTLE (68788-7946-2) 20 tablet2021-06-280000-00-00NoNoCurrent
68788-7946-36878879460330 TABLET in 1 BOTTLE (68788-7946-3) 30 tablet2021-06-280000-00-00NoNoCurrent
68788-7946-66878879460660 TABLET in 1 BOTTLE (68788-7946-6) 60 tablet2021-06-280000-00-00NoNoCurrent
68788-7946-868788794608120 TABLET in 1 BOTTLE (68788-7946-8) 120 tablet2021-06-280000-00-00NoNoCurrent
68788-7946-96878879460990 TABLET in 1 BOTTLE (68788-7946-9) 90 tablet2021-06-280000-00-00NoNoCurrent