FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
43598-060
11-digit product format
435980060
Labeler code
43598
Product ID
43598-060_7f658fac-fde0-3b5d-f8ad-15dcaf71cdad
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Dr.Reddy's Laboratories Inc
Application
ANDA075168
Marketing category
ANDA
Marketing start
2021-08-05
Substance
NAPROXEN SODIUM
Active strength
220 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 Sodium
Brand name suffix
Back and Muscle Pain Caplets
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574

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
43598-060-52Naproxen Sodium Back and Muscle Pain Caplets225 in 1 BOTTLETABLET, COATED2256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-060NAPROXEN SODIUM HEADACHE PAIN CAPLETS (NAPROXEN SODIUM) TABLET, COATED NAPROXEN SODIUM BACK AND MUSCLE PAIN CAPLETS (NAPROXEN SODIUM) TABLET, COATED [DR.REDDY'S LABORATORIES INC]5Current NDC, Legacy NDC, 1 package rows20241203_605ca130-88aa-27d5-330c-6d9c95987f1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN605ca130-88aa-27d5-330c-6d9c95987f1f6
849574naproxen sodium 220 MG Oral TabletSCD605ca130-88aa-27d5-330c-6d9c95987f1f6
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY605ca130-88aa-27d5-330c-6d9c95987f1f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-060-5243598006052225 TABLET, COATED in 1 BOTTLE (43598-060-52) 2021-08-050000-00-00NoNoCurrent