FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
71335-9663
11-digit product format
713359663
Labeler code
71335
Product ID
71335-9663_52f58a40-f574-43c7-947f-724eb615f66e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212199
Marketing category
ANDA
Marketing start
2019-10-30
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
71335-9663-0Naproxen Sodium6 in 1 BOTTLETABLET6102
71335-9663-1Naproxen Sodium20 in 1 BOTTLETABLET20102
71335-9663-2Naproxen Sodium100 in 1 BOTTLETABLET100102
71335-9663-3Naproxen Sodium30 in 1 BOTTLETABLET30102
71335-9663-4Naproxen Sodium120 in 1 BOTTLETABLET120102
71335-9663-5Naproxen Sodium60 in 1 BOTTLETABLET60102
71335-9663-6Naproxen Sodium90 in 1 BOTTLETABLET90102
71335-9663-7Naproxen Sodium42 in 1 BOTTLETABLET42102
71335-9663-8Naproxen Sodium14 in 1 BOTTLETABLET14102
71335-9663-9Naproxen Sodium56 in 1 BOTTLETABLET56102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9663-3EA - Each71335-9663e5ddb3d7-f747-4ed3-afe1-0c4df9d322a512025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9663NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [BRYANT RANCH PREPACK]101Current NDC, 10 package rows20231019_f6f4a670-235e-4235-84a8-a74dc8ca5586.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSNf6f4a670-235e-4235-84a8-a74dc8ca5586102
849431naproxen sodium 550 MG Oral TabletSCDf6f4a670-235e-4235-84a8-a74dc8ca5586102
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSYf6f4a670-235e-4235-84a8-a74dc8ca5586102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9663-0713359663006 TABLET in 1 BOTTLE (71335-9663-0) 6 tablet2026-04-13NoNoHistorical
71335-9663-17133596630120 TABLET in 1 BOTTLE (71335-9663-1) 20 tablet2023-04-20NoNoHistorical
71335-9663-271335966302100 TABLET in 1 BOTTLE (71335-9663-2) 100 tablet2026-04-13NoNoHistorical
71335-9663-37133596630330 TABLET in 1 BOTTLE (71335-9663-3) 30 tablet2025-01-24NoNoHistorical
71335-9663-471335966304120 TABLET in 1 BOTTLE (71335-9663-4) 120 tablet2026-04-13NoNoHistorical
71335-9663-57133596630560 TABLET in 1 BOTTLE (71335-9663-5) 60 tablet2023-03-08NoNoHistorical
71335-9663-67133596630690 TABLET in 1 BOTTLE (71335-9663-6) 90 tablet2026-04-13NoNoHistorical
71335-9663-77133596630742 TABLET in 1 BOTTLE (71335-9663-7) 42 tablet2026-04-13NoNoHistorical
71335-9663-87133596630814 TABLET in 1 BOTTLE (71335-9663-8) 14 tablet2026-04-13NoNoHistorical
71335-9663-97133596630956 TABLET in 1 BOTTLE (71335-9663-9) 56 tablet2026-04-13NoNoHistorical