FDA.reportPublic FDA data

Naproxen

Product NDC
71205-597
11-digit product format
712050597
Labeler code
71205
Product ID
71205-597_58d04fa7-f30f-4f9e-834c-f63b2c0431a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
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
71205-597-10Naproxen10 in 1 BOTTLETABLET106
71205-597-14Naproxen14 in 1 BOTTLETABLET146
71205-597-15Naproxen15 in 1 BOTTLETABLET156
71205-597-20Naproxen20 in 1 BOTTLETABLET206
71205-597-30Naproxen30 in 1 BOTTLETABLET306
71205-597-40Naproxen40 in 1 BOTTLETABLET406
71205-597-60Naproxen60 in 1 BOTTLETABLET606
71205-597-90Naproxen90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-597-10EA - Each71205-597a373b152-007e-446e-8dd6-db2fb4500d7712021-10-08
71205-597-14EA - Each71205-597bf2bfc03-66ce-4bdc-bd71-fa086f18f4e212022-05-04
71205-597-15EA - Each71205-597c8d97cc8-ce93-41e0-a196-96c2ae9e13e012022-12-07
71205-597-20EA - Each71205-597f2d27934-21f3-4f81-9070-ef8000d2337112022-03-09
71205-597-30EA - Each71205-59762b7d57f-20d1-481b-8612-bcbf8341075a12021-10-08
71205-597-40EA - Each71205-59750da342a-49e5-4f98-95b6-d459312524ba12022-03-09
71205-597-60EA - Each71205-5977ac09cbe-9df3-4fea-8d31-a370c687b2a512022-01-06
71205-597-90EA - Each71205-597fb51a8f4-2a7e-4df7-9608-c11b129007f412023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-597NAPROXEN TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 8 package rows20221110_d0670241-f1f9-4fdf-83d4-547e7b800811.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNd0670241-f1f9-4fdf-83d4-547e7b8008116
198014naproxen 500 MG Oral TabletSCDd0670241-f1f9-4fdf-83d4-547e7b8008116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-597-107120505971010 TABLET in 1 BOTTLE (71205-597-10) 10 tablet2021-08-060000-00-00NoNoCurrent
71205-597-147120505971414 TABLET in 1 BOTTLE (71205-597-14) 14 tablet2021-08-260000-00-00NoNoCurrent
71205-597-157120505971515 TABLET in 1 BOTTLE (71205-597-15) 15 tablet2022-11-070000-00-00NoNoCurrent
71205-597-207120505972020 TABLET in 1 BOTTLE (71205-597-20) 20 tablet2021-09-200000-00-00NoNoCurrent
71205-597-307120505973030 TABLET in 1 BOTTLE (71205-597-30) 30 tablet2021-08-040000-00-00NoNoCurrent
71205-597-407120505974040 TABLET in 1 BOTTLE (71205-597-40) 40 tablet2021-11-240000-00-00NoNoCurrent
71205-597-607120505976060 TABLET in 1 BOTTLE (71205-597-60) 60 tablet2021-08-040000-00-00NoNoCurrent
71205-597-907120505979090 TABLET in 1 BOTTLE (71205-597-90) 90 tablet2021-08-040000-00-00NoNoCurrent