FDA.reportPublic FDA data

ESOMEPRAZOLE MAGNESIUM

Product NDC
16571-880
11-digit product format
165710880
Labeler code
16571
Product ID
16571-880_cd6b21e6-4d3f-40b5-89ee-52a1c83d8700
Type
HUMAN OTC DRUG
Nonproprietary name
ESOMEPRAZOLE MAGNESIUM
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA216349
Marketing category
ANDA
Marketing start
2022-12-01
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
16571-880-41ESOMEPRAZOLE MAGNESIUM1 in 1 CARTONCAPSULE, DELAYED RELEASE13
16571-880-41ESOMEPRAZOLE MAGNESIUM14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
16571-880-42ESOMEPRAZOLE MAGNESIUM3 in 1 CARTONCAPSULE, DELAYED RELEASE33
16571-880-42ESOMEPRAZOLE MAGNESIUM14 in 1 BOTTLECAPSULE, DELAYED RELEASE143

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-880-41EA - Each16571-880ddc7f7e0-8006-4f45-ab41-97b296b9fe0812023-02-06
16571-880-42EA - Each16571-880b73f769c-f3ce-451b-92dc-ac7bf4c5832b12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-880ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [RISING PHARMA HOLDINGS, INC.]3Current NDC, Legacy NDC, 4 package rows20230514_07ba5747-702f-47fc-9d80-5a70296b64bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN07ba5747-702f-47fc-9d80-5a70296b64bf3
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD07ba5747-702f-47fc-9d80-5a70296b64bf3
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY07ba5747-702f-47fc-9d80-5a70296b64bf3
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY07ba5747-702f-47fc-9d80-5a70296b64bf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-880-41165710880411 BOTTLE in 1 CARTON (16571-880-41) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2022-12-010000-00-00NoNoCurrent
16571-880-42165710880423 BOTTLE in 1 CARTON (16571-880-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2022-12-010000-00-00NoNoCurrent