FDA.reportPublic FDA data

Naproxen

Product NDC
71335-2777
11-digit product format
713352777
Labeler code
71335
Product ID
71335-2777_7218d46c-3db2-4c6e-8b5b-58b8d576d4d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200429
Marketing category
ANDA
Marketing start
2011-11-08
Substance
NAPROXEN
Active strength
500 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
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198014

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
71335-2777-0Naproxen28 in 1 BOTTLETABLET281
71335-2777-1Naproxen30 in 1 BOTTLETABLET301
71335-2777-2Naproxen60 in 1 BOTTLETABLET601
71335-2777-3Naproxen10 in 1 BOTTLETABLET101
71335-2777-4Naproxen90 in 1 BOTTLETABLET901
71335-2777-5Naproxen20 in 1 BOTTLETABLET201
71335-2777-6Naproxen120 in 1 BOTTLETABLET1201
71335-2777-7Naproxen14 in 1 BOTTLETABLET141
71335-2777-8Naproxen42 in 1 BOTTLETABLET421
71335-2777-9Naproxen40 in 1 BOTTLETABLET401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2777-2EA - Each71335-27773f63e4e2-eb12-45a5-9584-72a86fc027e112025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNe0f430fd-4511-41c8-b5e9-894abe4f3c371
198014naproxen 500 MG Oral TabletSCDe0f430fd-4511-41c8-b5e9-894abe4f3c371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2777-07133527770028 TABLET in 1 BOTTLE (71335-2777-0) 28 tablet2025-10-13NoNoHistorical
71335-2777-17133527770130 TABLET in 1 BOTTLE (71335-2777-1) 30 tablet2025-10-13NoNoHistorical
71335-2777-27133527770260 TABLET in 1 BOTTLE (71335-2777-2) 60 tablet2025-10-13NoNoHistorical
71335-2777-37133527770310 TABLET in 1 BOTTLE (71335-2777-3) 10 tablet2025-10-13NoNoHistorical
71335-2777-47133527770490 TABLET in 1 BOTTLE (71335-2777-4) 90 tablet2025-10-13NoNoHistorical
71335-2777-57133527770520 TABLET in 1 BOTTLE (71335-2777-5) 20 tablet2025-10-13NoNoHistorical
71335-2777-671335277706120 TABLET in 1 BOTTLE (71335-2777-6) 120 tablet2025-10-13NoNoHistorical
71335-2777-77133527770714 TABLET in 1 BOTTLE (71335-2777-7) 14 tablet2025-10-13NoNoHistorical
71335-2777-87133527770842 TABLET in 1 BOTTLE (71335-2777-8) 42 tablet2025-10-13NoNoHistorical
71335-2777-97133527770940 TABLET in 1 BOTTLE (71335-2777-9) 40 tablet2025-10-13NoNoHistorical