FDA.reportPublic FDA data

Esomeprazole Magnesium

Product NDC
69230-320
11-digit product format
692300320
Labeler code
69230
Product ID
69230-320_3203036c-7c7d-04ac-e063-6394a90a132b
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Camber Consumer Care Inc
Application
ANDA212507
Marketing category
ANDA
Marketing start
2020-06-02
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

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
69230-320-31Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE15
69230-320-31Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
69230-320-32Esomeprazole Magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE25
69230-320-32Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
69230-320-33Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE35
69230-320-33Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE145

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-320-31EA - Each69230-320b6c4335e-6e47-44c7-8641-1cda75926ae812021-01-08
69230-320-32EA - Each69230-32048091071-7734-4ee4-86b2-e6f21e25675312021-01-08
69230-320-33EA - Each69230-3205e3d8d4f-1608-4d97-a29b-d9d3d368986312021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-320ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CAMBER CONSUMER CARE INC]5Current NDC, Legacy NDC, 6 package rows20250410_d2554c3d-eb0b-4bf8-aebc-18be7b195c8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNd2554c3d-eb0b-4bf8-aebc-18be7b195c8e5
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDd2554c3d-eb0b-4bf8-aebc-18be7b195c8e5
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYd2554c3d-eb0b-4bf8-aebc-18be7b195c8e5
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYd2554c3d-eb0b-4bf8-aebc-18be7b195c8e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69230-320-31692300320311 BOTTLE in 1 CARTON (69230-320-31) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2020-06-020000-00-00NoNoCurrent
69230-320-32692300320322 BOTTLE in 1 CARTON (69230-320-32) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2020-06-020000-00-00NoNoCurrent
69230-320-33692300320333 BOTTLE in 1 CARTON (69230-320-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2020-06-020000-00-00NoNoCurrent