FDA.reportPublic FDA data

esomeprazole magnesium

Product NDC
70377-056
11-digit product format
703770056
Labeler code
70377
Product ID
70377-056_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
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM40 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
70377-056-11esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
70377-056-12esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE905
70377-056-13esomeprazole magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-056ESOMEPRAZOLE 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 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
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN2d21ed0b-a089-46f4-9ebb-f24f9f3af61d3
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNe6e1906f-60be-402f-97f4-6d7bea1a6c083
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD2d21ed0b-a089-46f4-9ebb-f24f9f3af61d3
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDe6e1906f-60be-402f-97f4-6d7bea1a6c083
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY2d21ed0b-a089-46f4-9ebb-f24f9f3af61d3
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYe6e1906f-60be-402f-97f4-6d7bea1a6c083
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN7b92ac4f-50c9-4061-b4a7-535a58cea8f61
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNf99f95a2-60e4-4781-80a9-e5b12897dff11
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNf2f75067-1f22-0b24-e053-2995a90a6dff1
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDf99f95a2-60e4-4781-80a9-e5b12897dff11
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDf2f75067-1f22-0b24-e053-2995a90a6dff1
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD7b92ac4f-50c9-4061-b4a7-535a58cea8f61
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYf2f75067-1f22-0b24-e053-2995a90a6dff1
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY7b92ac4f-50c9-4061-b4a7-535a58cea8f61
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYf99f95a2-60e4-4781-80a9-e5b12897dff11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70377-056-117037700561130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-056-11) 2021-03-190000-00-00NoNoCurrent
70377-056-127037700561290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-056-12) 2021-03-190000-00-00NoNoCurrent
70377-056-13703770056131000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-056-13) 2021-03-190000-00-00NoNoCurrent