FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
13668-548
11-digit product format
136680548
Labeler code
13668
Product ID
13668-548_56badfc0-fbd5-4810-a66b-40b8843c94ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
GRANULE, DELAYED RELEASE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA212652
Marketing category
ANDA
Marketing start
2025-03-05
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
10 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 MAGNESIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9
Rxcui861568

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
13668-548-94Esomeprazole Magnesiumfor delayed-release oral suspension30 in 1 CARTONGRANULE, DELAYED RELEASE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-548ESOMEPRAZOLE MAGNESIUM FOR DELAYED-RELEASE ORAL SUSPENSION (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]6Current NDC, 1 package rows20250313_f907e633-4080-44ae-829f-141497876922.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861568esomeprazole 10 MG Granules for Delayed Release Oral SuspensionPSNf907e633-4080-44ae-829f-1414978769226
861568esomeprazole 10 MG Granules for Oral SuspensionSCDf907e633-4080-44ae-829f-1414978769226
861568esomeprazole 10 MG (equivalent to esomeprazole magnesium 11.1 MG) Granules for Delayed Release Oral SuspensionSYf907e633-4080-44ae-829f-1414978769226
861568esomeprazole 10 MG Granules for Delayed Release Oral SuspensionSYf907e633-4080-44ae-829f-1414978769226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
13668-548-941366805489430 GRANULE, DELAYED RELEASE in 1 CARTON (13668-548-94) 2025-03-05NoNoCurrent