FDA.reportPublic FDA data

ESOMEPRAZOLE MAGNESIUM

Product NDC
69097-527
11-digit product format
690970527
Labeler code
69097
Product ID
69097-527_95dea6c3-8880-42b2-a2d4-8cf93629127e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESOMEPRAZOLE MAGNESIUM
Dosage form
GRANULE, FOR SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA211752
Marketing category
ANDA
Marketing start
2020-03-24
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
69097-527-34ESOMEPRAZOLE MAGNESIUM30 in 1 CARTONGRANULE, FOR SUSPENSION, EXTENDE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-527-34EA - Each69097-527b9b7c33a-7315-4adf-a052-25d6f0b4235212020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-527ESOMEPRAZOLE MAGNESIUM GRANULE, FOR SUSPENSION, EXTENDED RELEASE [CIPLA USA INC.]7Current NDC, Legacy NDC, 1 package rows20240517_180490d1-c165-4bb9-96b1-12e727256e4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861568esomeprazole 10 MG Granules for Delayed Release Oral SuspensionPSN180490d1-c165-4bb9-96b1-12e727256e4e7
861568esomeprazole 10 MG Granules for Oral SuspensionSCD180490d1-c165-4bb9-96b1-12e727256e4e7
861568esomeprazole 10 MG (equivalent to esomeprazole magnesium 11.1 MG) Granules for Delayed Release Oral SuspensionSY180490d1-c165-4bb9-96b1-12e727256e4e7
861568esomeprazole 10 MG Granules for Delayed Release Oral SuspensionSY180490d1-c165-4bb9-96b1-12e727256e4e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-527-346909705273430 GRANULE, FOR SUSPENSION, EXTENDED RELEASE in 1 CARTON (69097-527-34) 2020-03-240000-00-00NoNoCurrent