FDA.reportPublic FDA data

Good Neighbor Pharmacy Esomeprazole Magnesium

Product NDC
46122-641
11-digit product format
461220641
Labeler code
46122
Product ID
46122-641_855c9137-5be7-405e-82af-61c6cd8ed401
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA207193
Marketing category
ANDA
Marketing start
2020-03-13
Substance
ESOMEPRAZOLE
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
Good Neighbor Pharmacy Esomeprazole Magnesium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN3PA6559FT
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
46122-641-04Good Neighbor Pharmacy Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE32
46122-641-63Good Neighbor Pharmacy Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-641-04EA - Each46122-641e8c194bc-ff93-45ff-85f6-031101dff38512021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-641GOOD NEIGHBOR PHARMACY ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]2Current NDC, Legacy NDC, 2 package rows20240802_b596055c-98b2-47b1-b174-ae7ad3ba97ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNb596055c-98b2-47b1-b174-ae7ad3ba97ee2
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDb596055c-98b2-47b1-b174-ae7ad3ba97ee2
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYb596055c-98b2-47b1-b174-ae7ad3ba97ee2
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYb596055c-98b2-47b1-b174-ae7ad3ba97ee2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-641-04461220641043 BOTTLE in 1 CARTON (46122-641-04) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46122-641-63) 3 bottle2020-03-130000-00-00NoNoCurrent
46122-641-634612206416314 in 1 BOTTLEHistorical