Esomeprazole magnesium

Product NDC
71205-706
11-digit product format
712050706
Labeler code
71205
Product ID
71205-706_a56790ec-e88d-4673-bcdc-c0fe34d4daff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium delayed release capsules
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA210559
Marketing category
ANDA
Marketing start
2021-02-27
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

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
71205-706-30Esomeprazole magnesium30 in 1 BOTTLECAPSULE, COATED PELLETS302
71205-706-60Esomeprazole magnesium60 in 1 BOTTLECAPSULE, COATED PELLETS602
71205-706-90Esomeprazole magnesium90 in 1 BOTTLECAPSULE, COATED PELLETS902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-706-30EA - Each71205-706261ba642-675a-4ca8-84a1-d08bda88f62f12022-12-07
71205-706-60EA - Each71205-706750fc1d7-92a0-48bd-9e87-67bf4ac4669612023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-706ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES) CAPSULE, COATED PELLETS [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20241018_ad05cdde-a9e9-4442-80c4-1b02f5ebf6b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNad05cdde-a9e9-4442-80c4-1b02f5ebf6b42
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDad05cdde-a9e9-4442-80c4-1b02f5ebf6b42
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYad05cdde-a9e9-4442-80c4-1b02f5ebf6b42
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYad05cdde-a9e9-4442-80c4-1b02f5ebf6b42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-706-307120507063030 CAPSULE, COATED PELLETS in 1 BOTTLE (71205-706-30) 2022-10-130000-00-00NoNoCurrent
71205-706-607120507066060 CAPSULE, COATED PELLETS in 1 BOTTLE (71205-706-60) 2022-10-130000-00-00NoNoCurrent
71205-706-907120507069090 CAPSULE, COATED PELLETS in 1 BOTTLE (71205-706-90) 2022-10-130000-00-00NoNoCurrent