FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
0480-0953
11-digit product format
004800953
Labeler code
0480
Product ID
0480-0953_6d02cbbb-bfb4-4c68-8a7b-4207f6f9cfbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naproxen sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA075416
Marketing category
ANDA
Marketing start
2022-11-01
Substance
NAPROXEN SODIUM
Active strength
750 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui1116320, 1116339, 1116349

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
0480-0953-56Naproxen Sodium30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-0953-56EA - Each0480-09536eab579a-d045-4b14-a3fe-7bdc62f83b8d12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-0953NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 1 package rows20250123_826fd9e3-22fe-408b-820c-f2b710189555.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116320naproxen sodium 375 MG 24HR Extended Release Oral TabletPSN826fd9e3-22fe-408b-820c-f2b7101895556
1116339naproxen sodium 500 MG 24HR Extended Release Oral TabletPSN826fd9e3-22fe-408b-820c-f2b7101895556
1116349naproxen sodium 750 MG 24HR Extended Release Oral TabletPSN826fd9e3-22fe-408b-820c-f2b7101895556
111632024 HR naproxen 375 MG Extended Release Oral TabletSCD826fd9e3-22fe-408b-820c-f2b7101895556
111633924 HR naproxen 500 MG Extended Release Oral TabletSCD826fd9e3-22fe-408b-820c-f2b7101895556
111634924 HR naproxen 750 MG Extended Release Oral TabletSCD826fd9e3-22fe-408b-820c-f2b7101895556
1116320naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral TabletSY826fd9e3-22fe-408b-820c-f2b7101895556
1116339naproxen 500 MG (naproxen sodium 550 MG) 24 HR Extended Release Oral TabletSY826fd9e3-22fe-408b-820c-f2b7101895556
1116349naproxen 750 MG (as naproxen sodium 825 MG) 24 HR Extended Release Oral TabletSY826fd9e3-22fe-408b-820c-f2b7101895556

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0480-0953-560048009535630 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0480-0953-56) 2022-11-010000-00-00NoNoCurrent