FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
59651-561
11-digit product format
596510561
Labeler code
59651
Product ID
59651-561_23ef720d-d1c4-498e-b54a-ecaf96e19fcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA205606
Marketing category
ANDA
Marketing start
2023-11-20
Substance
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
Active strength
20 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 MAGNESIUM TRIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR6DXU4WAY9
Rxcui606726, 606730

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-561-01Esomeprazole Magnesium100 in 1 BOTTLECAPSULE, DELAYED RELEASE1003
59651-561-14Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE13
59651-561-14Esomeprazole Magnesium14 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE143
59651-561-30Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
59651-561-90Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE903
59651-561-99Esomeprazole Magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-561-30EA - Each59651-56100f33432-23b7-46b4-8332-6909b6233a2512026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-561ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]3Current NDC, 6 package rows20250417_7038a0bc-99b2-4a6e-9b9a-0646ec187706.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN7038a0bc-99b2-4a6e-9b9a-0646ec1877063
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN7038a0bc-99b2-4a6e-9b9a-0646ec1877063
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD7038a0bc-99b2-4a6e-9b9a-0646ec1877063
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD7038a0bc-99b2-4a6e-9b9a-0646ec1877063
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY7038a0bc-99b2-4a6e-9b9a-0646ec1877063
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY7038a0bc-99b2-4a6e-9b9a-0646ec1877063
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY7038a0bc-99b2-4a6e-9b9a-0646ec1877063

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-561-0159651056101100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-561-01) 2023-11-20NoNoHistorical
59651-561-14596510561141 BLISTER PACK in 1 CARTON (59651-561-14) / 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2023-11-20NoNoHistorical
59651-561-305965105613030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-561-30) 2023-11-20NoNoHistorical
59651-561-905965105619090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-561-90) 2023-11-20NoNoHistorical
59651-561-99596510561991000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-561-99) 2023-11-20NoNoHistorical