FDA.reportPublic FDA data

Naproxen

Product NDC
68788-8844
11-digit product format
687888844
Labeler code
68788
Product ID
68788-8844_727913f6-9542-4a2d-9318-4b7ff521bffd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078250
Marketing category
ANDA
Marketing start
2025-03-20
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
68788-8844-1Naproxen100 in 1 BOTTLETABLET1001
68788-8844-2Naproxen20 in 1 BOTTLETABLET201
68788-8844-3Naproxen30 in 1 BOTTLETABLET301
68788-8844-6Naproxen60 in 1 BOTTLETABLET601
68788-8844-8Naproxen120 in 1 BOTTLETABLET1201
68788-8844-9Naproxen90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8844-1EA - Each68788-884479927c56-ddb1-481a-91db-8315c598cd7312025-05-14
68788-8844-2EA - Each68788-8844be4edde6-9633-4f90-96c0-b7ba5b74471f12025-05-14
68788-8844-3EA - Each68788-88449c319dd8-4650-415f-a5ed-14e41bd5b8cb12025-05-14
68788-8844-6EA - Each68788-88444834104f-97ef-43f5-a9c7-91df1440837312025-05-14
68788-8844-8EA - Each68788-88441ba56768-bc30-4b43-8273-e235e743018212025-05-14
68788-8844-9EA - Each68788-884462087650-db6e-447f-bdbd-cd5a1fb3559012025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8844NAPROXEN TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 6 package rows20250323_727913f6-9542-4a2d-9318-4b7ff521bffd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198012naproxen 375 MG Oral TabletPSN727913f6-9542-4a2d-9318-4b7ff521bffd1
198012naproxen 375 MG Oral TabletSCD727913f6-9542-4a2d-9318-4b7ff521bffd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8844-168788884401100 TABLET in 1 BOTTLE (68788-8844-1) 100 tablet2025-03-20NoNoHistorical
68788-8844-26878888440220 TABLET in 1 BOTTLE (68788-8844-2) 20 tablet2025-03-20NoNoHistorical
68788-8844-36878888440330 TABLET in 1 BOTTLE (68788-8844-3) 30 tablet2025-03-20NoNoHistorical
68788-8844-66878888440660 TABLET in 1 BOTTLE (68788-8844-6) 60 tablet2025-03-20NoNoHistorical
68788-8844-868788884408120 TABLET in 1 BOTTLE (68788-8844-8) 120 tablet2025-03-20NoNoHistorical
68788-8844-96878888440990 TABLET in 1 BOTTLE (68788-8844-9) 90 tablet2025-03-20NoNoHistorical