NAPROXEN

Product NDC
50436-0618
11-digit product format
504360618
Labeler code
50436
Product ID
50436-0618_6d262080-c732-4e93-b045-944c721f6e9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA091416
Marketing category
ANDA
Marketing start
2016-07-06
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0618-1NAPROXEN30 in 1 BOTTLETABLET302
50436-0618-2NAPROXEN60 in 1 BOTTLETABLET602
50436-0618-3NAPROXEN90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0618-1EA - Each50436-0618fda8e34e-51b3-4bdb-af2d-651f9ee5aa1812021-10-08
50436-0618-2EA - Each50436-0618ee925bad-bdab-49a5-8e81-21a93d4b6a4e12021-10-08
50436-0618-3EA - Each50436-0618408b8e3a-84d0-4519-99bf-94cb98c27f7012021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0618NAPROXEN TABLET [UNIT DOSE SERVICES]2Legacy NDC, 3 package rows20210919_1f416e0b-378b-4514-9b8e-7d8cce766d91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN1f416e0b-378b-4514-9b8e-7d8cce766d912
198014naproxen 500 MG Oral TabletSCD1f416e0b-378b-4514-9b8e-7d8cce766d912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-0618-15043606180130 TABLET in 1 BOTTLE (50436-0618-1) 30 tablet2021-09-170000-00-00NoNoCurrent
50436-0618-25043606180260 TABLET in 1 BOTTLE (50436-0618-2) 60 tablet2021-09-170000-00-00NoNoCurrent
50436-0618-35043606180390 TABLET in 1 BOTTLE (50436-0618-3) 90 tablet2021-09-170000-00-00NoNoCurrent