Naproxen

Product NDC
76420-787
11-digit product format
764200787
Labeler code
76420
Product ID
76420-787_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
250 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
NAPROXEN250 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
76420-787-01Naproxen1 in 1 BOTTLETABLET12
76420-787-02Naproxen2 in 1 BOTTLETABLET22
76420-787-05Naproxen500 in 1 BOTTLETABLET5002
76420-787-07Naproxen7 in 1 BOTTLETABLET72
76420-787-10Naproxen100 in 1 BOTTLETABLET1002
76420-787-14Naproxen14 in 1 BOTTLETABLET142
76420-787-20Naproxen20 in 1 BOTTLETABLET202
76420-787-30Naproxen30 in 1 BOTTLETABLET302
76420-787-60Naproxen60 in 1 BOTTLETABLET602
76420-787-90Naproxen90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-787NAPROXEN 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
76420-787-01764200787011 TABLET in 1 BOTTLE (76420-787-01) 1 tablet2024-03-19NoNoHistorical
76420-787-02764200787022 TABLET in 1 BOTTLE (76420-787-02) 2 tablet2024-03-19NoNoHistorical
76420-787-0576420078705500 TABLET in 1 BOTTLE (76420-787-05) 500 tablet2024-03-19NoNoHistorical
76420-787-07764200787077 TABLET in 1 BOTTLE (76420-787-07) 7 tablet2024-03-19NoNoHistorical
76420-787-1076420078710100 TABLET in 1 BOTTLE (76420-787-10) 100 tablet2024-03-19NoNoHistorical
76420-787-147642007871414 TABLET in 1 BOTTLE (76420-787-14) 14 tablet2024-03-19NoNoHistorical
76420-787-207642007872020 TABLET in 1 BOTTLE (76420-787-20) 20 tablet2024-03-19NoNoHistorical
76420-787-307642007873030 TABLET in 1 BOTTLE (76420-787-30) 30 tablet2024-03-19NoNoHistorical
76420-787-607642007876060 TABLET in 1 BOTTLE (76420-787-60) 60 tablet2024-03-19NoNoHistorical
76420-787-907642007879090 TABLET in 1 BOTTLE (76420-787-90) 90 tablet2024-03-19NoNoHistorical