Naproxen

Product NDC
76420-264
11-digit product format
764200264
Labeler code
76420
Product ID
76420-264_327a22dc-b87a-2758-e063-6394a90ae257
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
500 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
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198014

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
76420-264-01Naproxen1 in 1 BOTTLETABLET14
76420-264-02Naproxen2 in 1 BOTTLETABLET24
76420-264-05Naproxen500 in 1 BOTTLETABLET5004
76420-264-07Naproxen7 in 1 BOTTLETABLET74
76420-264-10Naproxen100 in 1 BOTTLETABLET1004
76420-264-12Naproxen120 in 1 BOTTLETABLET1204
76420-264-14Naproxen14 in 1 BOTTLETABLET144
76420-264-20Naproxen20 in 1 BOTTLETABLET204
76420-264-30Naproxen30 in 1 BOTTLETABLET304
76420-264-60Naproxen60 in 1 BOTTLETABLET604
76420-264-90Naproxen90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-264-01EA - Each76420-26425290b1e-9603-4e54-a9aa-fe29038d617912023-04-07
76420-264-02EA - Each76420-2647515f579-ac17-470d-9989-8f762c02562b12023-04-07
76420-264-05EA - Each76420-2647fda6185-53b6-4201-a628-7da24bc42e8412023-04-07
76420-264-07EA - Each76420-2640826323d-9074-4baa-9792-a7748f50e31f12023-05-05
76420-264-10EA - Each76420-2640472d120-105c-4329-a354-261012f7248312023-04-07
76420-264-14EA - Each76420-2640ce12fab-2c5d-47f8-95fc-85edf308dc6612023-04-07
76420-264-30EA - Each76420-26418795363-1adf-4eb4-a419-0cb227da0edf12023-04-07
76420-264-60EA - Each76420-2645bbcabb3-fa77-454e-9215-343827320bd112023-04-07
76420-264-90EA - Each76420-26428fc4f60-e874-44f0-a2de-76dd413262bc12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-264NAPROXEN TABLET [ASCLEMED USA, INC.]4Current NDC, Legacy NDC, 11 package rows20250413_1e406e47-408a-48cc-921e-52882a11581c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN1e406e47-408a-48cc-921e-52882a11581c4
198014naproxen 500 MG Oral TabletSCD1e406e47-408a-48cc-921e-52882a11581c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-264-01764200264011 TABLET in 1 BOTTLE (76420-264-01) 1 tablet2022-08-170000-00-00NoNoCurrent
76420-264-02764200264022 TABLET in 1 BOTTLE (76420-264-02) 2 tablet2022-08-170000-00-00NoNoCurrent
76420-264-0576420026405500 TABLET in 1 BOTTLE (76420-264-05) 500 tablet2022-08-170000-00-00NoNoCurrent
76420-264-07764200264077 TABLET in 1 BOTTLE (76420-264-07) 7 tablet2023-03-31NoNoCurrent
76420-264-1076420026410100 TABLET in 1 BOTTLE (76420-264-10) 100 tablet2022-08-170000-00-00NoNoCurrent
76420-264-1276420026412120 TABLET in 1 BOTTLE (76420-264-12) 120 tablet2025-04-11NoNoCurrent
76420-264-147642002641414 TABLET in 1 BOTTLE (76420-264-14) 14 tablet2022-08-170000-00-00NoNoCurrent
76420-264-207642002642020 TABLET in 1 BOTTLE (76420-264-20) 20 tablet2023-09-02NoNoCurrent
76420-264-307642002643030 TABLET in 1 BOTTLE (76420-264-30) 30 tablet2022-08-170000-00-00NoNoCurrent
76420-264-607642002646060 TABLET in 1 BOTTLE (76420-264-60) 60 tablet2022-08-170000-00-00NoNoCurrent
76420-264-907642002649090 TABLET in 1 BOTTLE (76420-264-90) 90 tablet2022-08-170000-00-00NoNoCurrent