FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
71335-3075
11-digit product format
713353075
Labeler code
71335
Product ID
71335-3075_405bbf1d-085e-461b-9b57-102cafa88a4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078314
Marketing category
ANDA
Marketing start
2007-08-01
Substance
NAPROXEN SODIUM
Active strength
550 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 SODIUM550 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849431

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
71335-3075-0Naproxen Sodium6 in 1 BOTTLETABLET61
71335-3075-1Naproxen Sodium20 in 1 BOTTLETABLET201
71335-3075-2Naproxen Sodium100 in 1 BOTTLETABLET1001
71335-3075-3Naproxen Sodium30 in 1 BOTTLETABLET301
71335-3075-4Naproxen Sodium120 in 1 BOTTLETABLET1201
71335-3075-5Naproxen Sodium60 in 1 BOTTLETABLET601
71335-3075-6Naproxen Sodium90 in 1 BOTTLETABLET901
71335-3075-7Naproxen Sodium42 in 1 BOTTLETABLET421
71335-3075-8Naproxen Sodium14 in 1 BOTTLETABLET141
71335-3075-9Naproxen Sodium56 in 1 BOTTLETABLET561

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-3075-0EA - Each71335-30756ee8dbf4-8173-4003-9e7b-9d4c34d1890e12026-04-20
71335-3075-1EA - Each71335-3075b7c9c423-01bc-45a3-ba3b-3a4dde8b6e5512026-04-20
71335-3075-2EA - Each71335-30754b39012a-a03f-4c9a-a111-04af76e25fb612026-04-20
71335-3075-3EA - Each71335-3075a841a990-1f3e-45b7-93c2-d6649ba6967112026-04-20
71335-3075-4EA - Each71335-3075e7f71bda-2c11-4a9f-9a44-144f2b2fefc312026-04-20
71335-3075-5EA - Each71335-30750fb2a444-1a3c-4f58-b6e6-9707bac8242012026-04-20
71335-3075-6EA - Each71335-30758effda1e-09f1-4d6d-b041-27cb1f3b638f12026-04-20
71335-3075-7EA - Each71335-307515af575b-e3ce-4d5a-afac-b4615c0970f712026-04-20
71335-3075-8EA - Each71335-30755b149c9f-ac13-421a-94b6-8a1545c7d25312026-04-20
71335-3075-9EA - Each71335-307572a31958-d1ab-400a-b2a2-7eeccf247ac212026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSN83dd8829-7ba0-4a8d-a979-41a5e077c49f1
849431naproxen sodium 550 MG Oral TabletSCD83dd8829-7ba0-4a8d-a979-41a5e077c49f1
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY83dd8829-7ba0-4a8d-a979-41a5e077c49f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3075-0713353075006 TABLET in 1 BOTTLE (71335-3075-0) 6 tablet2026-02-09NoNoHistorical
71335-3075-17133530750120 TABLET in 1 BOTTLE (71335-3075-1) 20 tablet2026-02-09NoNoHistorical
71335-3075-271335307502100 TABLET in 1 BOTTLE (71335-3075-2) 100 tablet2026-02-09NoNoHistorical
71335-3075-37133530750330 TABLET in 1 BOTTLE (71335-3075-3) 30 tablet2026-02-09NoNoHistorical
71335-3075-471335307504120 TABLET in 1 BOTTLE (71335-3075-4) 120 tablet2026-02-09NoNoHistorical
71335-3075-57133530750560 TABLET in 1 BOTTLE (71335-3075-5) 60 tablet2026-02-09NoNoHistorical
71335-3075-67133530750690 TABLET in 1 BOTTLE (71335-3075-6) 90 tablet2026-02-09NoNoHistorical
71335-3075-77133530750742 TABLET in 1 BOTTLE (71335-3075-7) 42 tablet2026-02-09NoNoHistorical
71335-3075-87133530750814 TABLET in 1 BOTTLE (71335-3075-8) 14 tablet2026-02-09NoNoHistorical
71335-3075-97133530750956 TABLET in 1 BOTTLE (71335-3075-9) 56 tablet2026-02-09NoNoHistorical