FDA.reportPublic FDA data

Esomeprazole magnesium

Product NDC
70010-133
11-digit product format
700100133
Labeler code
70010
Product ID
70010-133_451b3f2a-df20-47e9-e063-6394a90a7068
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA217427
Marketing category
ANDA
Marketing start
2023-10-18
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
70010-133-03Esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE304
70010-133-09Esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE904
70010-133-10Esomeprazole magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-133-03EA - Each70010-133d333d103-3f34-4d26-ae4d-633fb50e0e9312024-06-10
70010-133-09EA - Each70010-1334e62104a-557a-4f1d-b08b-1040f35f34a212024-06-10
70010-133-10EA - Each70010-133dfe6b5d5-7396-48ed-93db-4da7456cb02212024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-133ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [GRANULES PHARMACEUTICALS INC.]3Current NDC, 3 package rows20231114_651cfdb1-d7c7-45e6-add0-f40eea7722f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN651cfdb1-d7c7-45e6-add0-f40eea7722f74
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN651cfdb1-d7c7-45e6-add0-f40eea7722f74
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD651cfdb1-d7c7-45e6-add0-f40eea7722f74
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD651cfdb1-d7c7-45e6-add0-f40eea7722f74
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY651cfdb1-d7c7-45e6-add0-f40eea7722f74
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY651cfdb1-d7c7-45e6-add0-f40eea7722f74
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY651cfdb1-d7c7-45e6-add0-f40eea7722f74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70010-133-037001001330330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70010-133-03) 2023-10-18NoNoHistorical
70010-133-097001001330990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70010-133-09) 2023-11-13NoNoHistorical
70010-133-10700100133101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70010-133-10) 2023-10-18NoNoHistorical