FDA.reportPublic FDA data

esomeprazole magnesium

Product NDC
70377-055
11-digit product format
703770055
Labeler code
70377
Product ID
70377-055_b4ff12a6-841e-4eff-b9a4-bb814230eea5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Biocon Pharma Inc.,
Application
ANDA213486
Marketing category
ANDA
Marketing start
2021-03-19
Substance
ESOMEPRAZOLE MAGNESIUM
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 MAGNESIUM20 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
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
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
70377-055-11esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
70377-055-12esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE905
70377-055-13esomeprazole magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-055-11EA - Each70377-055d8fc7277-95bd-42eb-9a3f-b829a74094e812021-07-15
70377-055-12EA - Each70377-05576517f7e-0bfd-41fc-bdf4-cc90b4977a0712021-07-15
70377-055-13EA - Each70377-055d2f89447-f106-499b-a67c-74dec5931efe12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-055ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [BIOCON PHARMA INC.,]5Current NDC, Legacy NDC, 3 package rows20250302_66c9e2bf-2dc4-4683-89fd-6dadf1b01ee9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN2f1b1a56-b6c4-4e30-a1f7-12701aa5a535102
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD2f1b1a56-b6c4-4e30-a1f7-12701aa5a535102
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY2f1b1a56-b6c4-4e30-a1f7-12701aa5a535102
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY2f1b1a56-b6c4-4e30-a1f7-12701aa5a535102
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN66c9e2bf-2dc4-4683-89fd-6dadf1b01ee95
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN66c9e2bf-2dc4-4683-89fd-6dadf1b01ee95
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD66c9e2bf-2dc4-4683-89fd-6dadf1b01ee95
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD66c9e2bf-2dc4-4683-89fd-6dadf1b01ee95
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY66c9e2bf-2dc4-4683-89fd-6dadf1b01ee95
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY66c9e2bf-2dc4-4683-89fd-6dadf1b01ee95
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY66c9e2bf-2dc4-4683-89fd-6dadf1b01ee95
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNfe7d7aa8-4f46-83ae-e053-6394a90a01d62
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDfe7d7aa8-4f46-83ae-e053-6394a90a01d62
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYfe7d7aa8-4f46-83ae-e053-6394a90a01d62
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYfe7d7aa8-4f46-83ae-e053-6394a90a01d62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70377-055-117037700551130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-11) 2021-03-190000-00-00NoNoCurrent
70377-055-127037700551290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-12) 2021-03-190000-00-00NoNoCurrent
70377-055-13703770055131000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-13) 2021-03-190000-00-00NoNoCurrent