Esomeprazole Magnesium

Product NDC
13668-547
11-digit product format
136680547
Labeler code
13668
Product ID
13668-547_48a063bb-b163-40f3-ad34-728d86410249
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
GRANULE, DELAYED RELEASE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA212651
Marketing category
ANDA
Marketing start
2025-03-05
Substance
ESOMEPRAZOLE MAGNESIUM
Active strength
5 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 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212651-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 2.5MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05
A212651-002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 5MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05
A212651-003ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05
A212651-004ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A212651-001AB
A212651-002AB
A212651-003AB
A212651-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212651-001ESOMEPRAZOLE MAGNESIUMEQ 2.5MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05caaa826d4ba7…
2026-08-18 06:07:402026-07A212651-002ESOMEPRAZOLE MAGNESIUMEQ 5MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05caaa826d4ba7…
2026-08-18 06:07:402026-07A212651-003ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05caaa826d4ba7…
2026-08-18 06:07:402026-07A212651-004ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212651-001ESOMEPRAZOLE MAGNESIUMEQ 2.5MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212651-002ESOMEPRAZOLE MAGNESIUMEQ 5MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212651-003ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212651-004ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212651-001ESOMEPRAZOLE MAGNESIUMEQ 2.5MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212651-002ESOMEPRAZOLE MAGNESIUMEQ 5MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212651-003ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212651-004ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A212651-001ESOMEPRAZOLE MAGNESIUMEQ 2.5MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212651-002ESOMEPRAZOLE MAGNESIUMEQ 5MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212651-003ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212651-004ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212651-001ESOMEPRAZOLE MAGNESIUMEQ 2.5MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212651-002ESOMEPRAZOLE MAGNESIUMEQ 5MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212651-003ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212651-004ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212651-001ESOMEPRAZOLE MAGNESIUMEQ 2.5MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212651-002ESOMEPRAZOLE MAGNESIUMEQ 5MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212651-003ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212651-004ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2025-03-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A212651-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212651-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212651-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212651-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212651-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212651-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212651-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212651-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212651-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212651-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212651-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212651-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212651-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212651-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212651-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212651-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212651-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212651-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212651-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212651-004AB1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212651-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212651-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212651-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212651-004AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Esomeprazole Magnesium
Brand name suffix
for delayed-release oral suspension
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM5 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
692576Internal RxNorm lookup
692578Internal RxNorm lookup
1297658Internal RxNorm lookup
1297761Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
992b1830-55cc-4e95-8d6d-e7f796d5b373Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-547-94Esomeprazole Magnesiumfor delayed-release oral suspension30 in 1 CARTONGRANULE, DELAYED RELEASE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-547-94EA - Each13668-547619efc66-8748-44d6-9143-b5ba969586f912025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-547ESOMEPRAZOLE MAGNESIUM FOR DELAYED-RELEASE ORAL SUSPENSION (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]5Current NDC, 1 package rows20250313_992b1830-55cc-4e95-8d6d-e7f796d5b373.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole Magnesium for delayed-release oral suspensionESOMEPRAZOLE MAGNESIUMTorrent Pharmaceuticals Limited992b1830-55cc-4e95-8d6d-e7f796d5b3732025-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212651
application number: ANDA212651
ndc (product): 13668-547

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297658esomeprazole 2.5 MG Granules for Delayed Release Oral SuspensionPSN992b1830-55cc-4e95-8d6d-e7f796d5b3735
692576esomeprazole 20 MG Granules for Delayed Release Oral SuspensionPSN992b1830-55cc-4e95-8d6d-e7f796d5b3735
692578esomeprazole 40 MG Granules for Delayed Release Oral SuspensionPSN992b1830-55cc-4e95-8d6d-e7f796d5b3735
1297761esomeprazole 5 MG Granules for Delayed Release Oral SuspensionPSN992b1830-55cc-4e95-8d6d-e7f796d5b3735
1297658esomeprazole 2.5 MG Granules for Oral SuspensionSCD992b1830-55cc-4e95-8d6d-e7f796d5b3735
692576esomeprazole 20 MG Granules for Oral SuspensionSCD992b1830-55cc-4e95-8d6d-e7f796d5b3735
692578esomeprazole 40 MG Granules for Oral SuspensionSCD992b1830-55cc-4e95-8d6d-e7f796d5b3735
1297761esomeprazole 5 MG Granules for Oral SuspensionSCD992b1830-55cc-4e95-8d6d-e7f796d5b3735
1297658esomeprazole (as esomeprazole magnesium) 2.5 MG Granules for Delayed Release Oral SuspensionSY992b1830-55cc-4e95-8d6d-e7f796d5b3735
692576esomeprazole (as esomeprazole magnesium) 20 MG Granules for Delayed Release Oral SuspensionSY992b1830-55cc-4e95-8d6d-e7f796d5b3735
692576esomeprazole 20 MG Granules for Delayed Release Oral SuspensionSY992b1830-55cc-4e95-8d6d-e7f796d5b3735
692578esomeprazole 40 MG (equivalent to esomeprazole magnesium 44.5 MG) Granules for Delayed Release Oral SuspensionSY992b1830-55cc-4e95-8d6d-e7f796d5b3735
692578esomeprazole 40 MG Granules for Delayed Release Oral SuspensionSY992b1830-55cc-4e95-8d6d-e7f796d5b3735
1297761esomeprazole 5 MG (equivalent to esomeprazole magnesium 5.6 MG) Granules for Delayed Release Oral SuspensionSY992b1830-55cc-4e95-8d6d-e7f796d5b3735

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
13668-547-941366805479430 GRANULE, DELAYED RELEASE in 1 CARTON (13668-547-94) 2025-03-05NoNoCurrent