FDA.reportPublic FDA data

Naproxen

Product NDC
85766-107
11-digit product format
857660107
Labeler code
85766
Product ID
85766-107_5031fb96-af96-4e50-e063-6394a90a8c08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA212517
Marketing category
ANDA
Marketing start
2020-03-01
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
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
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198012, 198013, 198014

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
85766-107-00Naproxen1000 in 1 BOTTLETABLET10002
85766-107-01Naproxen100 in 1 BOTTLETABLET1002
85766-107-05Naproxen500 in 1 BOTTLETABLET5002
85766-107-10Naproxen10 in 1 BOTTLETABLET102
85766-107-14Naproxen14 in 1 BOTTLETABLET142
85766-107-20Naproxen20 in 1 BOTTLETABLET202
85766-107-30Naproxen30 in 1 BOTTLETABLET302
85766-107-60Naproxen60 in 1 BOTTLETABLET602
85766-107-90Naproxen90 in 1 BOTTLETABLET902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN1c5b2bc1-26bb-4f88-bded-399263c823312
198012naproxen 375 MG Oral TabletPSN1c5b2bc1-26bb-4f88-bded-399263c823312
198014naproxen 500 MG Oral TabletPSN1c5b2bc1-26bb-4f88-bded-399263c823312
198013naproxen 250 MG Oral TabletSCD1c5b2bc1-26bb-4f88-bded-399263c823312
198012naproxen 375 MG Oral TabletSCD1c5b2bc1-26bb-4f88-bded-399263c823312
198014naproxen 500 MG Oral TabletSCD1c5b2bc1-26bb-4f88-bded-399263c823312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-107-00857660107001000 TABLET in 1 BOTTLE (85766-107-00) 1000 tablet2025-10-15NoNoHistorical
85766-107-0185766010701100 TABLET in 1 BOTTLE (85766-107-01) 100 tablet2025-10-15NoNoHistorical
85766-107-0585766010705500 TABLET in 1 BOTTLE (85766-107-05) 500 tablet2025-10-15NoNoHistorical
85766-107-108576601071010 TABLET in 1 BOTTLE (85766-107-10) 10 tablet2025-10-15NoNoHistorical
85766-107-148576601071414 TABLET in 1 BOTTLE (85766-107-14) 14 tablet2025-10-15NoNoHistorical
85766-107-208576601072020 TABLET in 1 BOTTLE (85766-107-20) 20 tablet2025-10-15NoNoHistorical
85766-107-308576601073030 TABLET in 1 BOTTLE (85766-107-30) 30 tablet2025-10-15NoNoHistorical
85766-107-608576601076060 TABLET in 1 BOTTLE (85766-107-60) 60 tablet2025-10-15NoNoHistorical
85766-107-908576601079090 TABLET in 1 BOTTLE (85766-107-90) 90 tablet2025-10-15NoNoHistorical