Esomeprazole Magnesium

Product NDC
55111-492
11-digit product format
551110492
Labeler code
55111
Product ID
55111-492_be04a674-2f3c-368a-c3cf-0fb65f736cbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA078279
Marketing category
ANDA
Marketing start
2015-09-25
Marketing end
0000-00-00
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55111-492DDiscontinued by firm2026-08-11
excluded packagepackage55111-49255111-492-30DDiscontinued by firm2026-08-11
excluded packagepackage55111-49255111-492-90DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55111-492-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55111-492-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55111-492-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55111-492-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55111-492-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55111-492-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55111-492-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55111-492-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55111-492-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55111-492-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55111-492-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55111-492-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55111-492-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55111-492-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55111-492-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55111-492-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55111-492-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55111-492-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55111-492-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55111-492-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55111-492-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55111-492-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55111-492-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55111-492-90557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078279-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25
A078279-002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078279-001AB
A078279-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078279-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078279-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078279-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078279-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078279-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078279-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078279-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078279-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078279-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078279-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078279-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078279-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078279-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078279-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078279-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078279-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078279-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078279-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078279-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078279-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078279-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078279-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078279-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078279-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078279-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078279-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078279-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078279-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078279-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078279-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078279-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078279-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078279-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078279-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078279-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078279-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078279-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078279-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078279-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078279-002AB1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-492-30EA - Each55111-4923224ae53-0236-42e7-b0dd-505f23f811fa12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Esomeprazole MagnesiumACTIVE INGREDIENTR6DXU4WAY9ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
EsomeprazoleACTIVE MOIETYN3PA6559FTESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
AlcoholINACTIVE INGREDIENT3K9958V90MESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
AmmoniaINACTIVE INGREDIENT5138Q19F1XESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
Butyl AlcoholINACTIVE INGREDIENT8PJ61P6TS3ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
Fd&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
GelatinINACTIVE INGREDIENT2G86QN327LESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
HypromellosesINACTIVE INGREDIENT3NXW29V3WOESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
Magnesium StearateINACTIVE INGREDIENT70097M6I30ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
Methacrylic AcidINACTIVE INGREDIENT1CS02G8656ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
Potassium HydroxideINACTIVE INGREDIENTWZH3C48M4TESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
ShellacINACTIVE INGREDIENT46N107B71OESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
TalcINACTIVE INGREDIENT7SEV7J4R1UESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6
Triethyl CitrateINACTIVE INGREDIENT8Z96QXD6UMESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]6

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.a9d05a38-08db-4710-b6f3-20c92ce885d52026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAvPAK4db9f4b8-b6df-f6e9-e063-6294a90a9f602026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMNuCare Pharmaceuticals, Inc.463c9b3b-dd6b-7ee7-e063-6394a90afb432025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMPD-Rx Pharmaceuticals, Inc.fdea1f5f-b717-4d49-8d70-0b373c959bf02025-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMNuCare Pharmaceuticals,Inc.2879c79f-bf2a-0bc9-e063-6394a90a98ae2025-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMMajor Pharmaceuticalsba65c73d-fc7d-491e-aaaa-cf45a77833952025-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMMedsource Pharmaceuticals1278cf6f-cc7a-462b-e063-6394a90a34e52024-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions71956762-d2f7-4763-9afe-1ca8f32a3cbb2023-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions99fceec8-59a2-485f-a7f3-7c5afd98401d2023-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Inc15023261-51c8-2388-3439-48dace49ec022023-07-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMNorthStar Rx LLC380da8db-bfa3-8c0c-f8f3-573675fed9812023-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMProficient Rx LPe5540d90-0b6e-4519-9272-c6e96730967b2023-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMProficient Rx LP9224142a-6e14-4ca3-9e72-506ff9fbd0e12022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279