FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
71335-2294
11-digit product format
713352294
Labeler code
71335
Product ID
71335-2294_60bf4b42-31c4-4ebe-a925-18fc86daddb4
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
71335-2294-1Naproxen Sodium500 in 1 BOTTLETABLET500101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2294-1EA - Each71335-2294d53806f7-54dd-4088-8ccf-464c9c9f56d112024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2294NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20231207_2794b60d-d09b-4115-9ff2-07ff15524e78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSN2794b60d-d09b-4115-9ff2-07ff15524e78101
849431naproxen sodium 550 MG Oral TabletSCD2794b60d-d09b-4115-9ff2-07ff15524e78101
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY2794b60d-d09b-4115-9ff2-07ff15524e78101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2294-171335229401500 TABLET in 1 BOTTLE (71335-2294-1) 500 tablet2023-12-01NoNoHistorical