FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
13668-550
11-digit product format
136680550
Labeler code
13668
Product ID
13668-550_48a063bb-b163-40f3-ad34-728d86410249
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
GRANULE, DELAYED RELEASE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA212651
Marketing category
ANDA
Marketing start
2025-03-05
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
40 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], 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
Esomeprazole Magnesium
Brand name suffix
for delayed-release oral suspension
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9
Rxcui692576, 692578, 1297658, 1297761

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-550-94Esomeprazole Magnesiumfor delayed-release oral suspension30 in 1 CARTONGRANULE, DELAYED RELEASE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-550-94EA - Each13668-5501f0edf14-305c-4a2a-919a-1b50d6eedb8b12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-550ESOMEPRAZOLE MAGNESIUM FOR DELAYED-RELEASE ORAL SUSPENSION (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]5Current NDC, 1 package rows20250313_992b1830-55cc-4e95-8d6d-e7f796d5b373.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297658esomeprazole 2.5 MG Granules for Delayed Release Oral SuspensionPSN992b1830-55cc-4e95-8d6d-e7f796d5b3735
692576esomeprazole 20 MG Granules for Delayed Release Oral SuspensionPSN992b1830-55cc-4e95-8d6d-e7f796d5b3735
692578esomeprazole 40 MG Granules for Delayed Release Oral SuspensionPSN992b1830-55cc-4e95-8d6d-e7f796d5b3735
1297761esomeprazole 5 MG Granules for Delayed Release Oral SuspensionPSN992b1830-55cc-4e95-8d6d-e7f796d5b3735
1297658esomeprazole 2.5 MG Granules for Oral SuspensionSCD992b1830-55cc-4e95-8d6d-e7f796d5b3735
692576esomeprazole 20 MG Granules for Oral SuspensionSCD992b1830-55cc-4e95-8d6d-e7f796d5b3735
692578esomeprazole 40 MG Granules for Oral SuspensionSCD992b1830-55cc-4e95-8d6d-e7f796d5b3735
1297761esomeprazole 5 MG Granules for Oral SuspensionSCD992b1830-55cc-4e95-8d6d-e7f796d5b3735
1297658esomeprazole (as esomeprazole magnesium) 2.5 MG Granules for Delayed Release Oral SuspensionSY992b1830-55cc-4e95-8d6d-e7f796d5b3735
692576esomeprazole (as esomeprazole magnesium) 20 MG Granules for Delayed Release Oral SuspensionSY992b1830-55cc-4e95-8d6d-e7f796d5b3735
692576esomeprazole 20 MG Granules for Delayed Release Oral SuspensionSY992b1830-55cc-4e95-8d6d-e7f796d5b3735
692578esomeprazole 40 MG (equivalent to esomeprazole magnesium 44.5 MG) Granules for Delayed Release Oral SuspensionSY992b1830-55cc-4e95-8d6d-e7f796d5b3735
692578esomeprazole 40 MG Granules for Delayed Release Oral SuspensionSY992b1830-55cc-4e95-8d6d-e7f796d5b3735
1297761esomeprazole 5 MG (equivalent to esomeprazole magnesium 5.6 MG) Granules for Delayed Release Oral SuspensionSY992b1830-55cc-4e95-8d6d-e7f796d5b3735

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
13668-550-941366805509430 GRANULE, DELAYED RELEASE in 1 CARTON (13668-550-94) 2025-03-05NoNoHistorical