FDA.reportPublic FDA data

NAPROXEN

Product NDC
71335-0255
11-digit product format
713350255
Labeler code
71335
Product ID
71335-0255_f6ea33a2-ec65-4b5d-9fb8-d8beb4cc2138
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091416
Marketing category
ANDA
Marketing start
2016-07-06
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NAPROXEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198012, 198013

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0255-1NAPROXEN20 in 1 BOTTLETABLET209
71335-0255-2NAPROXEN30 in 1 BOTTLETABLET309
71335-0255-3NAPROXEN40 in 1 BOTTLETABLET409
71335-0255-4NAPROXEN120 in 1 BOTTLETABLET1209
71335-0255-5NAPROXEN60 in 1 BOTTLETABLET609
71335-0255-6NAPROXEN90 in 1 BOTTLETABLET909
71335-0255-7NAPROXEN14 in 1 BOTTLETABLET149
71335-0255-8NAPROXEN15 in 1 BOTTLETABLET159

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0255-2EA - Each71335-02550e7226cf-0a27-497d-8390-3bcc752e109012025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0255NAPROXEN TABLET [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 8 package rows20201215_5d399bf3-db49-411a-91b9-b410d702a65a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN5d399bf3-db49-411a-91b9-b410d702a65a9
198012naproxen 375 MG Oral TabletPSN5d399bf3-db49-411a-91b9-b410d702a65a9
198013naproxen 250 MG Oral TabletSCD5d399bf3-db49-411a-91b9-b410d702a65a9
198012naproxen 375 MG Oral TabletSCD5d399bf3-db49-411a-91b9-b410d702a65a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0255-17133502550120 TABLET in 1 BOTTLE (71335-0255-1) 20 tablet2017-10-020000-00-00NoNoCurrent
71335-0255-27133502550230 TABLET in 1 BOTTLE (71335-0255-2) 30 tablet2017-10-020000-00-00NoNoCurrent
71335-0255-37133502550340 TABLET in 1 BOTTLE (71335-0255-3) 40 tablet2017-10-020000-00-00NoNoCurrent
71335-0255-471335025504120 TABLET in 1 BOTTLE (71335-0255-4) 120 tablet2017-10-020000-00-00NoNoCurrent
71335-0255-57133502550560 TABLET in 1 BOTTLE (71335-0255-5) 60 tablet2017-10-020000-00-00NoNoCurrent
71335-0255-67133502550690 TABLET in 1 BOTTLE (71335-0255-6) 90 tablet2017-10-020000-00-00NoNoCurrent
71335-0255-77133502550714 TABLET in 1 BOTTLE (71335-0255-7) 14 tablet2017-10-020000-00-00NoNoCurrent
71335-0255-87133502550815 TABLET in 1 BOTTLE (71335-0255-8) 15 tablet2017-10-020000-00-00NoNoCurrent