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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212949-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02
A212949-002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A212949-001AB
A212949-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-0284e616aacf4f…
2026-09-14 22:38:342026-08A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-0284e616aacf4f…
2026-08-18 06:07:402026-07A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02caaa826d4ba7…
2026-08-18 06:07:402026-07A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-024b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212949-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212949-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-10-02bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A212949-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A212949-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A212949-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212949-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212949-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212949-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212949-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212949-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212949-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212949-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212949-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212949-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212949-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212949-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212949-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212949-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212949-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212949-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212949-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212949-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212949-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212949-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212949-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212949-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212949-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212949-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212949-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212949-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212949-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212949-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212949-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212949-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212949-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212949-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212949-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212949-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212949-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212949-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212949-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212949-002AB1bb7c543d1eb4…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R6DXU4WAY9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
606726Internal RxNorm lookup
606730Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
83fa2aab-f00d-4428-b961-d960247d7169Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.1348fb0e-dcdc-475d-b394-f405dff00f362025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212949
application number: ANDA212949
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMRising Pharma Holdings, Inc.83fa2aab-f00d-4428-b961-d960247d71692024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212949
application number: ANDA212949
ndc (product): 64980-633

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