FDA.reportPublic FDA data

Naproxen

Product NDC
67296-1797
11-digit product format
672961797
Labeler code
67296
Product ID
67296-1797_be3768bd-f900-46c1-e053-2995a90af132
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA212517
Marketing category
ANDA
Marketing start
2020-03-01
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
500 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1797-32026-01-29C16284748780-1f386c649-9d85-0266-e053-dadaa90a7c1aNaproxen 500mg tabs
67296-1797-62026-01-29C16284748780-1f386c649-9d85-0266-e053-dadaa90a7c1aNaproxen 500mg tabs
67296-1797-72026-01-29C16284748780-1f386c649-9d85-0266-e053-dadaa90a7c1aNaproxen 500mg tabs
67296-1797-92026-01-29C16284748780-1f386c649-9d85-0266-e053-dadaa90a7c1aNaproxen 500mg tabs
67296-1797-32024-07-25C16284748780-1f386c649-9d85-0266-e053-dadaa90a7c1aNaproxen 500mg tabs
67296-1797-62024-07-25C16284748780-1f386c649-9d85-0266-e053-dadaa90a7c1aNaproxen 500mg tabs
67296-1797-92024-07-25C16284748780-1f386c649-9d85-0266-e053-dadaa90a7c1aNaproxen 500mg tabs
67296-1797-32023-01-30C16284748780-1f386c649-9d85-0266-e053-dadaa90a7c1aNaproxen 500mg tabs
67296-1797-62023-01-30C16284748780-1f386c649-9d85-0266-e053-dadaa90a7c1aNaproxen 500mg tabs
67296-1797-92023-01-30C16284748780-1f386c649-9d85-0266-e053-dadaa90a7c1aNaproxen 500mg tabs

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1797-3Naproxen30 in 1 BOTTLETABLET308
67296-1797-6Naproxen6 in 1 BOTTLETABLET68
67296-1797-7Naproxen14 in 1 BOTTLETABLET148
67296-1797-9Naproxen60 in 1 BOTTLETABLET608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1797NAPROXEN TABLET [REDPHARM DRUG, INC.]8Legacy NDC, 4 package rows20240727_afebe3d8-97cc-3083-e053-2a95a90a0f9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNafebe3d8-97cc-3083-e053-2a95a90a0f9d8
198014naproxen 500 MG Oral TabletSCDafebe3d8-97cc-3083-e053-2a95a90a0f9d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1797-36729617970330 TABLET in 1 BOTTLE (67296-1797-3) 30 tablet2020-03-010000-00-00NoNoCurrent
67296-1797-6672961797066 TABLET in 1 BOTTLE (67296-1797-6) 6 tablet2020-03-010000-00-00NoNoCurrent
67296-1797-76729617970714 in 1 BOTTLEHistorical
67296-1797-96729617970960 TABLET in 1 BOTTLE (67296-1797-9) 60 tablet2020-03-010000-00-00NoNoCurrent