Naproxen

Product NDC
50436-0188
11-digit product format
504360188
Labeler code
50436
Product ID
50436-0188_8b64e24e-9b66-4314-aebd-3885948d3736
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA078250
Marketing category
ANDA
Marketing start
2007-07-01
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
250 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
2020-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0188-1Naproxen20 in 1 BOTTLETABLET204
50436-0188-4Naproxen20 in 1 BOTTLETABLET204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0188NAPROXEN TABLET [UNIT DOSE SERVICES]4Legacy NDC, 2 package rows20180228_c38ae25f-d73e-4f85-b450-87df87e989da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSNc38ae25f-d73e-4f85-b450-87df87e989da4
198014naproxen 500 MG Oral TabletPSNc38ae25f-d73e-4f85-b450-87df87e989da4
198013naproxen 250 MG Oral TabletSCDc38ae25f-d73e-4f85-b450-87df87e989da4
198014naproxen 500 MG Oral TabletSCDc38ae25f-d73e-4f85-b450-87df87e989da4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0188-15043601880120 in 1 BOTTLEHistorical
50436-0188-45043601880420 in 1 BOTTLEHistorical