FDA.reportPublic FDA data

Naproxen and esomeprazole magnesium

Product NDC
50228-438
11-digit product format
502280438
Labeler code
50228
Product ID
50228-438_2faf3061-f567-a5dc-e063-6294a90aff8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen and esomeprazole magnesium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc
Application
ANDA217738
Marketing category
ANDA
Marketing start
2023-10-11
Substance
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Active strength
20; 500 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen and esomeprazole magnesium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM20 mg/1
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9, 57Y76R9ATQ
Rxcui994005, 994008

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-438-05Naproxen and esomeprazole magnesium500 in 1 BOTTLETABLET, DELAYED RELEASE5003
50228-438-30Naproxen and esomeprazole magnesium30 in 1 BOTTLETABLET, DELAYED RELEASE303
50228-438-60Naproxen and esomeprazole magnesium60 in 1 BOTTLETABLET, DELAYED RELEASE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-438-60EA - Each50228-438d844f6bf-3e8d-431b-93c2-97fa427412b912024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-438NAPROXEN AND ESOMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE [SCIEGEN PHARMACEUTICALS, INC]3Current NDC, 3 package rows20250309_167340c2-1234-4d00-b4e2-cccf3d270fda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994005naproxen 375 MG / esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN167340c2-1234-4d00-b4e2-cccf3d270fda3
994008naproxen 500 MG / esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN167340c2-1234-4d00-b4e2-cccf3d270fda3
994005esomeprazole 20 MG / naproxen 375 MG Delayed Release Oral TabletSCD167340c2-1234-4d00-b4e2-cccf3d270fda3
994008esomeprazole 20 MG / naproxen 500 MG Delayed Release Oral TabletSCD167340c2-1234-4d00-b4e2-cccf3d270fda3
994005esomeprazole (as esomeprazole magnesium) 20 MG / naproxen (as naproxen sodium) 375 MG Delayed Release Oral TabletSY167340c2-1234-4d00-b4e2-cccf3d270fda3
994008naproxen 500 MG / esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN4c25c106-b5ca-079f-e063-6394a90a49781
994008naproxen 500 MG / esomeprazole magnesium 20 MG Delayed Release Oral TabletPSNf3a3eea2-f6b3-4559-8536-26c1125df3e11
994008esomeprazole 20 MG / naproxen 500 MG Delayed Release Oral TabletSCD4c25c106-b5ca-079f-e063-6394a90a49781
994008esomeprazole 20 MG / naproxen 500 MG Delayed Release Oral TabletSCDf3a3eea2-f6b3-4559-8536-26c1125df3e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50228-438-0550228043805500 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-438-05) 2023-10-11NoNoCurrent
50228-438-305022804383030 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-438-30) 2023-10-11NoNoCurrent
50228-438-605022804386060 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-438-60) 2024-03-12NoNoCurrent