FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
50228-433
11-digit product format
502280433
Labeler code
50228
Product ID
50228-433_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
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
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 SODIUM550 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
50228-433-01Naproxen Sodium100 in 1 BOTTLETABLET1004
50228-433-05Naproxen Sodium500 in 1 BOTTLETABLET5004
50228-433-10Naproxen Sodium1000 in 1 BOTTLETABLET10004
50228-433-30Naproxen Sodium30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-433NAPROXEN 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
849431naproxen sodium 550 MG Oral TabletPSNe9eb8c40-85d9-4c8e-9523-a21d3591260f104
849431naproxen sodium 550 MG Oral TabletPSNbee7b482-8ba5-411d-90ee-de00df50d2b7104
849431naproxen sodium 550 MG Oral TabletSCDe9eb8c40-85d9-4c8e-9523-a21d3591260f104
849431naproxen sodium 550 MG Oral TabletSCDbee7b482-8ba5-411d-90ee-de00df50d2b7104
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSYe9eb8c40-85d9-4c8e-9523-a21d3591260f104
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSYbee7b482-8ba5-411d-90ee-de00df50d2b7104
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
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
849431naproxen sodium 550 MG Oral TabletPSN145cdcc0-9bd5-4a0e-81fc-11a24d1819806
849431naproxen sodium 550 MG Oral TabletSCD145cdcc0-9bd5-4a0e-81fc-11a24d1819806
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY145cdcc0-9bd5-4a0e-81fc-11a24d1819806
849431naproxen sodium 550 MG Oral TabletPSN6ae413ba-5a48-423f-8b8d-7a42661cf8365
849431naproxen sodium 550 MG Oral TabletSCD6ae413ba-5a48-423f-8b8d-7a42661cf8365
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY6ae413ba-5a48-423f-8b8d-7a42661cf8365
849398naproxen sodium 275 MG Oral TabletPSN79f48c92-783d-40f2-9865-89958a9f9de64
849431naproxen sodium 550 MG Oral TabletPSN79f48c92-783d-40f2-9865-89958a9f9de64
849431naproxen sodium 550 MG Oral TabletPSN181c2d5b-2c61-bf20-e063-6294a90a3f7f4
849398naproxen sodium 275 MG Oral TabletSCD79f48c92-783d-40f2-9865-89958a9f9de64
849431naproxen sodium 550 MG Oral TabletSCD79f48c92-783d-40f2-9865-89958a9f9de64
849431naproxen sodium 550 MG Oral TabletSCD181c2d5b-2c61-bf20-e063-6294a90a3f7f4
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
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY181c2d5b-2c61-bf20-e063-6294a90a3f7f4
849431naproxen sodium 550 MG Oral TabletPSNb8e417d2-3fc8-9a5e-e053-2a95a90a41553
849431naproxen sodium 550 MG Oral TabletSCDb8e417d2-3fc8-9a5e-e053-2a95a90a41553
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSYb8e417d2-3fc8-9a5e-e053-2a95a90a41553
849431naproxen sodium 550 MG Oral TabletPSNa90bfc07-d01e-427c-b2df-41bff7612d2f2
849431naproxen sodium 550 MG Oral TabletPSN369911ea-9069-9c45-e063-6394a90a5ce62
849431naproxen sodium 550 MG Oral TabletPSNd95279d9-6e2a-0bd6-e053-2a95a90a447d2
849431naproxen sodium 550 MG Oral TabletSCDa90bfc07-d01e-427c-b2df-41bff7612d2f2
849431naproxen sodium 550 MG Oral TabletSCD369911ea-9069-9c45-e063-6394a90a5ce62
849431naproxen sodium 550 MG Oral TabletSCDd95279d9-6e2a-0bd6-e053-2a95a90a447d2
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSYa90bfc07-d01e-427c-b2df-41bff7612d2f2
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY369911ea-9069-9c45-e063-6394a90a5ce62
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSYd95279d9-6e2a-0bd6-e053-2a95a90a447d2
849398naproxen sodium 275 MG Oral TabletPSNb0571e62-9330-438d-a2ba-873477f52dc41
849431naproxen sodium 550 MG Oral TabletPSN4a05ca8c-1b03-fa86-e063-6394a90a41191
849431naproxen sodium 550 MG Oral TabletPSNb0571e62-9330-438d-a2ba-873477f52dc41
849431naproxen sodium 550 MG Oral TabletPSNd3a90745-5c6d-b93a-e053-2a95a90a35921
849398naproxen sodium 275 MG Oral TabletSCDb0571e62-9330-438d-a2ba-873477f52dc41
849431naproxen sodium 550 MG Oral TabletSCDd3a90745-5c6d-b93a-e053-2a95a90a35921
849431naproxen sodium 550 MG Oral TabletSCD4a05ca8c-1b03-fa86-e063-6394a90a41191
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 TabletSYd3a90745-5c6d-b93a-e053-2a95a90a35921
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSY4a05ca8c-1b03-fa86-e063-6394a90a41191
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
50228-433-0150228043301100 TABLET in 1 BOTTLE (50228-433-01) 100 tablet2019-10-300000-00-00NoNoCurrent
50228-433-0550228043305500 TABLET in 1 BOTTLE (50228-433-05) 500 tablet2019-10-300000-00-00NoNoCurrent
50228-433-10502280433101000 TABLET in 1 BOTTLE (50228-433-10) 1000 tablet2019-10-300000-00-00NoNoCurrent
50228-433-305022804333030 TABLET in 1 BOTTLE (50228-433-30) 30 tablet2019-10-300000-00-00NoNoCurrent