FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
71335-1925
11-digit product format
713351925
Labeler code
71335
Product ID
71335-1925_5106647a-1c82-4ebe-95f3-db46fb2398db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200629
Marketing category
ANDA
Marketing start
2011-10-31
Substance
NAPROXEN SODIUM
Active strength
275 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 Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM275 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849398

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
71335-1925-1Naproxen Sodium60 in 1 BOTTLETABLET, FILM COATED60104
71335-1925-2Naproxen Sodium90 in 1 BOTTLETABLET, FILM COATED90104
71335-1925-3Naproxen Sodium42 in 1 BOTTLETABLET, FILM COATED42104
71335-1925-4Naproxen Sodium20 in 1 BOTTLETABLET, FILM COATED20104
71335-1925-5Naproxen Sodium120 in 1 BOTTLETABLET, FILM COATED120104
71335-1925-6Naproxen Sodium30 in 1 BOTTLETABLET, FILM COATED30104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1925NAPROXEN SODIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 6 package rows20250226_1c2325f7-1d65-429d-a64d-6ab075df1c20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849398naproxen sodium 275 MG Oral TabletPSN1c2325f7-1d65-429d-a64d-6ab075df1c20104
849398naproxen sodium 275 MG Oral TabletSCD1c2325f7-1d65-429d-a64d-6ab075df1c20104
849398naproxen sodium 275 MG (as naproxen 250 MG) Oral TabletSY1c2325f7-1d65-429d-a64d-6ab075df1c20104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1925-17133519250160 TABLET, FILM COATED in 1 BOTTLE (71335-1925-1) 2025-01-300000-00-00NoNoCurrent
71335-1925-27133519250290 TABLET, FILM COATED in 1 BOTTLE (71335-1925-2) 2025-01-300000-00-00NoNoCurrent
71335-1925-37133519250342 TABLET, FILM COATED in 1 BOTTLE (71335-1925-3) 2025-01-300000-00-00NoNoCurrent
71335-1925-47133519250420 TABLET, FILM COATED in 1 BOTTLE (71335-1925-4) 2025-01-300000-00-00NoNoCurrent
71335-1925-571335192505120 TABLET, FILM COATED in 1 BOTTLE (71335-1925-5) 2025-01-300000-00-00NoNoCurrent
71335-1925-67133519250630 TABLET, FILM COATED in 1 BOTTLE (71335-1925-6) 2021-07-290000-00-00NoNoCurrent