FDA.reportPublic FDA data

Esomeprazole magnesium

Product NDC
64980-633
11-digit product format
649800633
Labeler code
64980
Product ID
64980-633_8e9751a1-6130-44a5-bbf5-45c75479b8d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA212949
Marketing category
ANDA
Marketing start
2024-07-26
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
40 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 MAGNESIUM40 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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-633-03Esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
64980-633-09Esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE901
64980-633-10Esomeprazole magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-633-03EA - Each64980-6337e5c26ae-1683-4ef0-b7ad-3a963e7d585712024-12-10
64980-633-09EA - Each64980-6335a783bfc-dbda-431d-89b5-da8acaa0f8ea12024-12-10
64980-633-10EA - Each64980-633a7a1923f-6abc-43b7-8755-499ce4c465e512024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-633ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [RISING PHARMA HOLDINGS, INC.]1Current NDC, 3 package rows20240726_83fa2aab-f00d-4428-b961-d960247d7169.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN83fa2aab-f00d-4428-b961-d960247d71691
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN83fa2aab-f00d-4428-b961-d960247d71691
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD83fa2aab-f00d-4428-b961-d960247d71691
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD83fa2aab-f00d-4428-b961-d960247d71691
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY83fa2aab-f00d-4428-b961-d960247d71691
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY83fa2aab-f00d-4428-b961-d960247d71691
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY83fa2aab-f00d-4428-b961-d960247d71691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
64980-633-036498006330330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64980-633-03) 2024-07-26NoNoCurrent
64980-633-096498006330990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64980-633-09) 2024-07-26NoNoCurrent
64980-633-10649800633101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64980-633-10) 2024-07-26NoNoCurrent