Esomeprazole Magnesium

Product NDC
16714-735
Requested package NDC
16714-735-01
11-digit product format
167140735
Labeler code
16714
Product ID
16714-735_26990f16-e3d3-4491-a99d-1cc5411f2e86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA205606
Marketing category
ANDA
Marketing start
2017-08-14
Marketing end
2021-12-01
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
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
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage16714-73516714-735-01DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
A205606-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21
A205606-002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205606-001AB
A205606-002AB

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 UTC2026-02A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21782e0a99824c…
2021-12-28 21:50 UTC2021-12A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21782e0a99824c…

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 UTC2026-02A205606-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205606-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205606-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205606-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205606-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205606-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205606-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205606-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205606-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205606-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205606-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205606-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205606-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205606-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205606-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205606-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205606-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205606-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205606-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205606-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205606-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205606-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205606-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205606-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205606-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205606-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205606-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205606-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205606-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205606-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205606-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205606-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205606-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205606-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205606-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205606-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205606-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205606-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205606-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205606-002AB1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-735-01EA - Each16714-73567a7f70b-2267-4953-9f71-1a6da4bf531712017-11-06
16714-735-02EA - Each16714-7356f2cd338-0451-43ca-883c-96cc94fa985e12017-11-06

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions71a4fa85-032b-4f50-a2ee-fd9642ae8b152026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205606
application number: ANDA205606
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions6ad71713-39da-460b-81fc-e5fba103b2152026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205606
application number: ANDA205606
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMNCS HealthCare of KY, LLC dba Vangard Labs28fbfa02-6c7b-4eb1-af24-86825e6523262026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205606
application number: ANDA205606
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMPD-Rx Pharmaceuticals, Inc.ac12cd05-10cf-4694-a9e8-e5f04fe162a72025-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205606
application number: ANDA205606
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAurobindo Pharma Limited7038a0bc-99b2-4a6e-9b9a-0646ec1877062025-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205606
application number: ANDA205606
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAurobindo Pharma Limitedf4ae091d-9b74-4a0e-ac68-057effd91e172025-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205606
application number: ANDA205606
Esomeprazole Magnesium DRESOMEPRAZOLE MAGNESIUMAdvanced Rx Pharmacy of Tennessee, LLCb4cd8ed1-d9d1-5b57-e053-2995a90a9f3c2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205606
application number: ANDA205606
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack009794ae-8199-4176-9dc6-4c5e752d845c2024-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205606
application number: ANDA205606

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-735-011671407350130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-735-01) 2017-08-142021-12-01NoNoCurrent