Naproxen

Product NDC
60760-564
11-digit product format
607600564
Labeler code
60760
Product ID
60760-564_4628dc14-d88e-0e7c-e063-6294a90a2126
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA212517
Marketing category
ANDA
Marketing start
2022-06-22
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
60760-564-14Naproxen14 in 1 BOTTLE, PLASTICTABLET143
60760-564-15Naproxen15 in 1 BOTTLE, PLASTICTABLET153
60760-564-20Naproxen20 in 1 BOTTLE, PLASTICTABLET203
60760-564-30Naproxen30 in 1 BOTTLE, PLASTICTABLET303
60760-564-60Naproxen60 in 1 BOTTLE, PLASTICTABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-564NAPROXEN TABLET [ST. MARY'S MEDICAL PARK PHARMACY]2Current NDC, Legacy NDC, 5 package rows20220819_e3a3e5d2-2d1e-74d3-e053-2995a90a82bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNe3a3e5d2-2d1e-74d3-e053-2995a90a82bf3
198014naproxen 500 MG Oral TabletSCDe3a3e5d2-2d1e-74d3-e053-2995a90a82bf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-564-146076005641414 TABLET in 1 BOTTLE, PLASTIC (60760-564-14) 14 tablet2022-06-220000-00-00NoNoCurrent
60760-564-156076005641515 TABLET in 1 BOTTLE, PLASTIC (60760-564-15) 15 tablet2022-06-220000-00-00NoNoCurrent
60760-564-206076005642020 TABLET in 1 BOTTLE, PLASTIC (60760-564-20) 20 tablet2022-06-220000-00-00NoNoCurrent
60760-564-306076005643030 TABLET in 1 BOTTLE, PLASTIC (60760-564-30) 30 tablet2022-08-150000-00-00NoNoCurrent
60760-564-606076005646060 TABLET in 1 BOTTLE, PLASTIC (60760-564-60) 60 tablet2022-06-220000-00-00NoNoCurrent