FDA.reportPublic FDA data

NAPROXEN

Product NDC
76420-042
11-digit product format
764200042
Labeler code
76420
Product ID
76420-042_ead160e6-aba4-ca0a-e053-2a95a90ab964
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA091416
Marketing category
ANDA
Marketing start
2016-07-06
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
76420-042-01NAPROXEN1 in 1 BOTTLE, PLASTICTABLET12
76420-042-02NAPROXEN2 in 1 BOTTLE, PLASTICTABLET22
76420-042-10NAPROXEN100 in 1 BOTTLE, PLASTICTABLET1002
76420-042-14NAPROXEN14 in 1 BOTTLE, PLASTICTABLET142
76420-042-30NAPROXEN30 in 1 BOTTLE, PLASTICTABLET302
76420-042-60NAPROXEN60 in 1 BOTTLE, PLASTICTABLET602
76420-042-90NAPROXEN90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-042-01EA - Each76420-042d6ab9467-3c29-468e-b0a8-2096f028e89012022-05-04
76420-042-02EA - Each76420-04274aee297-ab10-4449-80ee-fc005813b12612022-05-04
76420-042-10EA - Each76420-042447c5bd3-c20c-4180-9dac-061ff25eee2f12022-05-04
76420-042-14EA - Each76420-0427a29d39c-818a-4a8d-8ec5-f1f48f91f2de12022-05-04
76420-042-30EA - Each76420-04232abcc89-ecc6-4cc2-8033-f559f3a2fd3512022-05-04
76420-042-60EA - Each76420-0420270a367-569d-44fa-a01a-a7f3791ced6312022-05-04
76420-042-90EA - Each76420-042faf02c0d-6cc7-4171-a2df-c57ffb8fd74f12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-042NAPROXEN TABLET [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 7 package rows20221013_a4fcb411-c918-459b-adc6-06dfa8ed8a50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNa4fcb411-c918-459b-adc6-06dfa8ed8a502
198014naproxen 500 MG Oral TabletSCDa4fcb411-c918-459b-adc6-06dfa8ed8a502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-042-01764200042011 TABLET in 1 BOTTLE, PLASTIC (76420-042-01) 1 tablet2020-02-050000-00-00NoNoCurrent
76420-042-02764200042022 TABLET in 1 BOTTLE, PLASTIC (76420-042-02) 2 tablet2020-02-050000-00-00NoNoCurrent
76420-042-1076420004210100 TABLET in 1 BOTTLE, PLASTIC (76420-042-10) 100 tablet2020-02-050000-00-00NoNoCurrent
76420-042-147642000421414 TABLET in 1 BOTTLE, PLASTIC (76420-042-14) 14 tablet2020-02-050000-00-00NoNoCurrent
76420-042-307642000423030 TABLET in 1 BOTTLE, PLASTIC (76420-042-30) 30 tablet2020-02-050000-00-00NoNoCurrent
76420-042-607642000426060 TABLET in 1 BOTTLE, PLASTIC (76420-042-60) 60 tablet2020-02-050000-00-00NoNoCurrent
76420-042-907642000429090 TABLET in 1 BOTTLE, PLASTIC (76420-042-90) 90 tablet2020-02-050000-00-00NoNoCurrent