FDA.reportPublic FDA data

NAPROXEN

Product NDC
71335-0973
11-digit product format
713350973
Labeler code
71335
Product ID
71335-0973_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
250 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
NAPROXEN250 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
71335-0973-1NAPROXEN30 in 1 BOTTLETABLET309
71335-0973-2NAPROXEN60 in 1 BOTTLETABLET609
71335-0973-3NAPROXEN20 in 1 BOTTLETABLET209
71335-0973-4NAPROXEN120 in 1 BOTTLETABLET1209
71335-0973-5NAPROXEN10 in 1 BOTTLETABLET109
71335-0973-6NAPROXEN90 in 1 BOTTLETABLET909
71335-0973-7NAPROXEN40 in 1 BOTTLETABLET409
71335-0973-8NAPROXEN45 in 1 BOTTLETABLET459

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0973-1EA - Each71335-09738d2fe8c0-3a43-4735-b913-58b2db6f929612021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0973NAPROXEN 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
71335-0973-17133509730130 TABLET in 1 BOTTLE (71335-0973-1) 30 tablet2018-10-230000-00-00NoNoCurrent
71335-0973-27133509730260 TABLET in 1 BOTTLE (71335-0973-2) 60 tablet2018-10-230000-00-00NoNoCurrent
71335-0973-37133509730320 TABLET in 1 BOTTLE (71335-0973-3) 20 tablet2018-10-230000-00-00NoNoCurrent
71335-0973-471335097304120 TABLET in 1 BOTTLE (71335-0973-4) 120 tablet2018-10-230000-00-00NoNoCurrent
71335-0973-57133509730510 TABLET in 1 BOTTLE (71335-0973-5) 10 tablet2018-10-230000-00-00NoNoCurrent
71335-0973-67133509730690 TABLET in 1 BOTTLE (71335-0973-6) 90 tablet2018-10-230000-00-00NoNoCurrent
71335-0973-77133509730740 TABLET in 1 BOTTLE (71335-0973-7) 40 tablet2018-10-230000-00-00NoNoCurrent
71335-0973-87133509730845 TABLET in 1 BOTTLE (71335-0973-8) 45 tablet2018-10-230000-00-00NoNoCurrent