FDA.reportPublic FDA data

NAPROXEN

Product NDC
61919-204
11-digit product format
619190204
Labeler code
61919
Product ID
61919-204_eac6245a-d2fa-5f81-e053-2995a90a41e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA075927
Marketing category
ANDA
Marketing start
2017-05-22
Marketing end
0000-00-00
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
2023-12-31
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
61919-204-142025-01-30C16284748780-12cef2736-6617-d83d-e063-dadaa90ab31fNAPROXEN
61919-204-202025-01-30C16284748780-12cef2736-6617-d83d-e063-dadaa90ab31fNAPROXEN
61919-204-282025-01-30C16284748780-12cef2736-6617-d83d-e063-dadaa90ab31fNAPROXEN
61919-204-302025-01-30C16284748780-12cef2736-6617-d83d-e063-dadaa90ab31fNAPROXEN
61919-204-602025-01-30C16284748780-12cef2736-6617-d83d-e063-dadaa90ab31fNAPROXEN
61919-204-902025-01-30C16284748780-12cef2736-6617-d83d-e063-dadaa90ab31fNAPROXEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-204-14NAPROXEN14 in 1 BOTTLETABLET147
61919-204-20NAPROXEN20 in 1 BOTTLETABLET207
61919-204-28NAPROXEN28 in 1 BOTTLETABLET287
61919-204-30NAPROXEN30 in 1 BOTTLETABLET307
61919-204-60NAPROXEN60 in 1 BOTTLETABLET607
61919-204-90NAPROXEN90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-204-14EA - Each61919-20467df4128-30c6-48a8-b2d4-09f6df3a403212023-03-13
61919-204-20EA - Each61919-20423670ca8-0e7e-4bf3-b9e9-d08eec130be412023-04-07
61919-204-28EA - Each61919-2046e6344b9-a692-4c9d-b041-69dcb15ca8c612023-04-07
61919-204-30EA - Each61919-2048059a643-e23a-4493-9731-3a9b80e8f69812017-07-07
61919-204-60EA - Each61919-204ce3c1b17-ae9e-4619-a4a2-6d7c155c82c712017-07-07
61919-204-90EA - Each61919-204a1510b7b-98f1-4fe9-b7f0-b00e9ec9742d12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-204NAPROXEN TABLET [DIRECT RX]7Legacy NDC, 6 package rows20230414_50217b0f-a696-6c82-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN50217b0f-a696-6c82-e054-00144ff88e887
198014naproxen 500 MG Oral TabletSCD50217b0f-a696-6c82-e054-00144ff88e887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-204-146191902041414 TABLET in 1 BOTTLE (61919-204-14) 14 tablet2017-05-220000-00-00NoNoCurrent
61919-204-206191902042020 TABLET in 1 BOTTLE (61919-204-20) 20 tablet2017-05-220000-00-00NoNoCurrent
61919-204-286191902042828 in 1 BOTTLEHistorical
61919-204-306191902043030 TABLET in 1 BOTTLE (61919-204-30) 30 tablet2017-05-220000-00-00NoNoCurrent
61919-204-606191902046060 TABLET in 1 BOTTLE (61919-204-60) 60 tablet2017-05-220000-00-00NoNoCurrent
61919-204-906191902049090 TABLET in 1 BOTTLE (61919-204-90) 90 tablet2017-05-220000-00-00NoNoCurrent