FDA.reportPublic FDA data

Naproxen

Product NDC
76420-788
11-digit product format
764200788
Labeler code
76420
Product ID
76420-788_14060e9c-4605-5493-e063-6294a90ab6d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA212517
Marketing category
ANDA
Marketing start
2020-03-01
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, 198013

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
76420-788-01Naproxen1 in 1 BOTTLETABLET12
76420-788-02Naproxen2 in 1 BOTTLETABLET22
76420-788-05Naproxen500 in 1 BOTTLETABLET5002
76420-788-07Naproxen7 in 1 BOTTLETABLET72
76420-788-10Naproxen100 in 1 BOTTLETABLET1002
76420-788-14Naproxen14 in 1 BOTTLETABLET142
76420-788-20Naproxen20 in 1 BOTTLETABLET202
76420-788-30Naproxen30 in 1 BOTTLETABLET302
76420-788-60Naproxen60 in 1 BOTTLETABLET602
76420-788-90Naproxen90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-788NAPROXEN TABLET [ASCLEMED USA, INC.]2Current NDC, 10 package rows20240321_5a48c0d4-37bf-4c26-a9a7-5c67ff2adb4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN5a48c0d4-37bf-4c26-a9a7-5c67ff2adb4b2
198012naproxen 375 MG Oral TabletPSN5a48c0d4-37bf-4c26-a9a7-5c67ff2adb4b2
198013naproxen 250 MG Oral TabletSCD5a48c0d4-37bf-4c26-a9a7-5c67ff2adb4b2
198012naproxen 375 MG Oral TabletSCD5a48c0d4-37bf-4c26-a9a7-5c67ff2adb4b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-788-01764200788011 TABLET in 1 BOTTLE (76420-788-01) 1 tablet2024-03-19NoNoHistorical
76420-788-02764200788022 TABLET in 1 BOTTLE (76420-788-02) 2 tablet2024-03-19NoNoHistorical
76420-788-0576420078805500 TABLET in 1 BOTTLE (76420-788-05) 500 tablet2024-03-19NoNoHistorical
76420-788-07764200788077 TABLET in 1 BOTTLE (76420-788-07) 7 tablet2024-03-19NoNoHistorical
76420-788-1076420078810100 TABLET in 1 BOTTLE (76420-788-10) 100 tablet2024-03-19NoNoHistorical
76420-788-147642007881414 TABLET in 1 BOTTLE (76420-788-14) 14 tablet2024-03-19NoNoHistorical
76420-788-207642007882020 TABLET in 1 BOTTLE (76420-788-20) 20 tablet2024-03-19NoNoHistorical
76420-788-307642007883030 TABLET in 1 BOTTLE (76420-788-30) 30 tablet2024-03-19NoNoHistorical
76420-788-607642007886060 TABLET in 1 BOTTLE (76420-788-60) 60 tablet2024-03-19NoNoHistorical
76420-788-907642007889090 TABLET in 1 BOTTLE (76420-788-90) 90 tablet2024-03-19NoNoHistorical