NAPROXEN

Product NDC
61919-162
11-digit product format
619190162
Labeler code
61919
Product ID
61919-162_f202b8ea-9615-7a4b-e053-2a95a90a008d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078250
Marketing category
ANDA
Marketing start
2016-08-29
Marketing end
0000-00-00
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
2024-12-31
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
61919-162-302025-01-30C16284748780-12cef2736-b53a-d83d-e063-dadaa90ab31fNAPROXEN
61919-162-602025-01-30C16284748780-12cef2736-b53a-d83d-e063-dadaa90ab31fNAPROXEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-162-30NAPROXEN30 in 1 BOTTLETABLET305
61919-162-60NAPROXEN60 in 1 BOTTLETABLET605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-162-30EA - Each61919-16217d2d273-b6d0-4bb4-ace9-023593e773cb12019-12-10
61919-162-60EA - Each61919-162edec13aa-1eba-4888-8ebd-42217eaa851912019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-162NAPROXEN TABLET [DIRECT RX]5Legacy NDC, 2 package rows20230413_3b36a761-64dc-673f-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198012naproxen 375 MG Oral TabletPSN3b36a761-64dc-673f-e054-00144ff88e885
198012naproxen 375 MG Oral TabletSCD3b36a761-64dc-673f-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-162-306191901623030 TABLET in 1 BOTTLE (61919-162-30) 30 tablet2016-08-290000-00-00NoNoCurrent
61919-162-606191901626060 TABLET in 1 BOTTLE (61919-162-60) 60 tablet2016-08-290000-00-00NoNoCurrent