FDA.reportPublic FDA data

Naproxen and esomeprazole magnesium

Product NDC
55111-289
11-digit product format
551110289
Labeler code
55111
Product ID
55111-289_e222148e-ce6f-2205-e8e3-4e40219a12f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen and esomeprazole magnesium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA204206
Marketing category
ANDA
Marketing start
2020-02-18
Substance
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Active strength
20; 375 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
NAPROXEN375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ, R6DXU4WAY9
Rxcui994005, 994008

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
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
55111-289-60Naproxen and esomeprazole magnesium60 in 1 BOTTLETABLET, DELAYED RELEASE6020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-289-60EA - Each55111-28972b4603b-0b8a-4860-8e87-7a79c2f328aa12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-289NAPROXEN AND ESOMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED ]20Current NDC, Legacy NDC, 1 package rows20250417_1ef3fe94-9bbb-934d-a09b-d19a1d23a4d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994005naproxen 375 MG / esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN1ef3fe94-9bbb-934d-a09b-d19a1d23a4d520
994008naproxen 500 MG / esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN1ef3fe94-9bbb-934d-a09b-d19a1d23a4d520
994005esomeprazole 20 MG / naproxen 375 MG Delayed Release Oral TabletSCD1ef3fe94-9bbb-934d-a09b-d19a1d23a4d520
994008esomeprazole 20 MG / naproxen 500 MG Delayed Release Oral TabletSCD1ef3fe94-9bbb-934d-a09b-d19a1d23a4d520
994005esomeprazole (as esomeprazole magnesium) 20 MG / naproxen (as naproxen sodium) 375 MG Delayed Release Oral TabletSY1ef3fe94-9bbb-934d-a09b-d19a1d23a4d520
994005naproxen 375 MG / esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN7b3af5a8-0c92-43f4-af13-7a47dca20e921
994008naproxen 500 MG / esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN7b3af5a8-0c92-43f4-af13-7a47dca20e921
994005esomeprazole 20 MG / naproxen 375 MG Delayed Release Oral TabletSCD7b3af5a8-0c92-43f4-af13-7a47dca20e921
994008esomeprazole 20 MG / naproxen 500 MG Delayed Release Oral TabletSCD7b3af5a8-0c92-43f4-af13-7a47dca20e921
994005esomeprazole (as esomeprazole magnesium) 20 MG / naproxen (as naproxen sodium) 375 MG Delayed Release Oral TabletSY7b3af5a8-0c92-43f4-af13-7a47dca20e921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55111-289-605511102896060 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-289-60) 2020-02-180000-00-00NoNoCurrent