FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
50228-432
11-digit product format
502280432
Labeler code
50228
Product ID
50228-432_42789c45-a1bd-b3f9-e063-6294a90a8067
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA212199
Marketing category
ANDA
Marketing start
2019-10-30
Substance
NAPROXEN SODIUM
Active strength
275 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 SODIUM275 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849398, 849431

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
50228-432-01Naproxen Sodium100 in 1 BOTTLETABLET1004
50228-432-05Naproxen Sodium500 in 1 BOTTLETABLET5004
50228-432-10Naproxen Sodium1000 in 1 BOTTLETABLET10004
50228-432-30Naproxen Sodium30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-432-01EA - Each50228-43241d46275-ee42-4888-b81b-341318fb452312020-06-05
50228-432-05EA - Each50228-432a1453713-9650-4b5b-9a9b-0e11dd9a576812020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-432NAPROXEN SODIUM TABLET NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [SCIEGEN PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 4 package rows20210803_79f48c92-783d-40f2-9865-89958a9f9de6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849398naproxen sodium 275 MG Oral TabletPSN79f48c92-783d-40f2-9865-89958a9f9de64
849431naproxen sodium 550 MG Oral TabletPSN79f48c92-783d-40f2-9865-89958a9f9de64
849398naproxen sodium 275 MG Oral TabletSCD79f48c92-783d-40f2-9865-89958a9f9de64
849431naproxen sodium 550 MG Oral TabletSCD79f48c92-783d-40f2-9865-89958a9f9de64
849398naproxen sodium 275 MG (as naproxen 250 MG) Oral TabletSY79f48c92-783d-40f2-9865-89958a9f9de64
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY79f48c92-783d-40f2-9865-89958a9f9de64
849398naproxen sodium 275 MG Oral TabletPSNb0571e62-9330-438d-a2ba-873477f52dc41
849431naproxen sodium 550 MG Oral TabletPSNb0571e62-9330-438d-a2ba-873477f52dc41
849398naproxen sodium 275 MG Oral TabletSCDb0571e62-9330-438d-a2ba-873477f52dc41
849431naproxen sodium 550 MG Oral TabletSCDb0571e62-9330-438d-a2ba-873477f52dc41
849398naproxen sodium 275 MG (as naproxen 250 MG) Oral TabletSYb0571e62-9330-438d-a2ba-873477f52dc41
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSYb0571e62-9330-438d-a2ba-873477f52dc41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-432-0150228043201100 TABLET in 1 BOTTLE (50228-432-01) 100 tablet2019-10-300000-00-00NoNoCurrent
50228-432-0550228043205500 TABLET in 1 BOTTLE (50228-432-05) 500 tablet2019-10-300000-00-00NoNoCurrent
50228-432-10502280432101000 TABLET in 1 BOTTLE (50228-432-10) 1000 tablet2019-10-300000-00-00NoNoCurrent
50228-432-305022804323030 TABLET in 1 BOTTLE (50228-432-30) 30 tablet2019-10-300000-00-00NoNoCurrent