FDA.reportPublic FDA data

Naproxen

Product NDC
71335-1850
11-digit product format
713351850
Labeler code
71335
Product ID
71335-1850_e5a7112d-c916-4151-9307-cc7d801db648
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212517
Marketing category
ANDA
Marketing start
2020-03-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198012

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
71335-1850-1Naproxen20 in 1 BOTTLETABLET20106
71335-1850-2Naproxen30 in 1 BOTTLETABLET30106
71335-1850-3Naproxen40 in 1 BOTTLETABLET40106
71335-1850-4Naproxen120 in 1 BOTTLETABLET120106
71335-1850-5Naproxen60 in 1 BOTTLETABLET60106
71335-1850-6Naproxen90 in 1 BOTTLETABLET90106
71335-1850-7Naproxen14 in 1 BOTTLETABLET14106
71335-1850-8Naproxen15 in 1 BOTTLETABLET15106
71335-1850-9Naproxen21 in 1 BOTTLETABLET21106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1850-5EA - Each71335-185050ec109f-453e-4447-98c4-bf0fdc9e3aab12025-09-12
71335-1850-6EA - Each71335-1850b7247ac3-d0af-4afe-be65-329c23eb1d6612025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1850NAPROXEN TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 9 package rows20240809_bbc61c0a-491a-4f50-a7bf-2ca94c771568.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198012naproxen 375 MG Oral TabletPSNbbc61c0a-491a-4f50-a7bf-2ca94c771568106
198012naproxen 375 MG Oral TabletSCDbbc61c0a-491a-4f50-a7bf-2ca94c771568106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1850-17133518500120 TABLET in 1 BOTTLE (71335-1850-1) 20 tablet2021-12-210000-00-00NoNoCurrent
71335-1850-27133518500230 TABLET in 1 BOTTLE (71335-1850-2) 30 tablet2021-12-210000-00-00NoNoCurrent
71335-1850-37133518500340 TABLET in 1 BOTTLE (71335-1850-3) 40 tablet2021-12-210000-00-00NoNoCurrent
71335-1850-471335185004120 TABLET in 1 BOTTLE (71335-1850-4) 120 tablet2021-12-210000-00-00NoNoCurrent
71335-1850-57133518500560 TABLET in 1 BOTTLE (71335-1850-5) 60 tablet2021-12-210000-00-00NoNoCurrent
71335-1850-67133518500690 TABLET in 1 BOTTLE (71335-1850-6) 90 tablet2021-12-210000-00-00NoNoCurrent
71335-1850-77133518500714 TABLET in 1 BOTTLE (71335-1850-7) 14 tablet2021-12-210000-00-00NoNoCurrent
71335-1850-87133518500815 TABLET in 1 BOTTLE (71335-1850-8) 15 tablet2021-12-210000-00-00NoNoCurrent
71335-1850-97133518500921 TABLET in 1 BOTTLE (71335-1850-9) 21 tablet2021-12-21NoNoCurrent