Esomeprazole Magnesium

Product NDC: 0378-2351
11-digit product format: 003782351
Labeler code: 0378
Product ID: 0378-2351_e0389e97-0278-4684-b6b7-d4c19a151f6f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esomeprazole Magnesium
Dosage form: CAPSULE, DELAYED RELEASE PELLETS
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA078936
Marketing category: ANDA
Marketing start: 2015-08-03
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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078936-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2015-08-02
A078936-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2015-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078936-001	AB
A078936-002	AB

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078936-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078936-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078936-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078936-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078936-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078936-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078936-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078936-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078936-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078936-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078936-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078936-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078936-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078936-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078936-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078936-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078936-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078936-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078936-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078936-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078936-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078936-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078936-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078936-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078936-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078936-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078936-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078936-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078936-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078936-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078936-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078936-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078936-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078936-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078936-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078936-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078936-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078936-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078936-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078936-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078936-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078936-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Esomeprazole Magnesium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESOMEPRAZOLE MAGNESIUM	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R6DXU4WAY9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
e04e7c84-59c8-4a1d-8dfc-d72588b97b59	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1	Product name	6	20251027
d71865e8-5c35-4d76-8ecd-a7adda982240	Product name	9	20180628
d71865e8-5c35-4d76-8ecd-a7adda982240	Product name	8	20171212
094c6751-235c-4d12-acee-2baf94f676f4	Product name	1	20151116
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-2351-77	Esomeprazole Magnesium	90 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE PELLETS	90		15
0378-2351-93	Esomeprazole Magnesium	30 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE PELLETS	30		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-2351-10	EA - Each	0378-2351	99d0f652-3ec6-4493-bace-85fd8327fc73	1	2015-09-10
0378-2351-77	EA - Each	0378-2351	43c11c39-1152-4bcc-a3a6-5266803cb733	1	2016-01-13
0378-2351-93	EA - Each	0378-2351	cb42b292-38d5-45dd-9a2c-80a559cc22ee	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESOMEPRAZOLE MAGNESIUM	ACTIVE INGREDIENT	R6DXU4WAY9	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2
ESOMEPRAZOLE	ACTIVE MOIETY	N3PA6559FT	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-2351	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.]	15	Current NDC, Legacy NDC, 2 package rows	20240229_e04e7c84-59c8-4a1d-8dfc-d72588b97b59.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Mylan Pharmaceuticals Inc.	e04e7c84-59c8-4a1d-8dfc-d72588b97b59	2023-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078936 application number: ANDA078936 ndc (product): 0378-2351

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R6DXU4WAY9	ESOMEPRAZOLE MAGNESIUM	217087-09-7	ESOMEPRAZOLE MAGNESIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
606726	esomeprazole magnesium 20 MG Delayed Release Oral Capsule	PSN	e04e7c84-59c8-4a1d-8dfc-d72588b97b59	15
606730	esomeprazole magnesium 40 MG Delayed Release Oral Capsule	PSN	e04e7c84-59c8-4a1d-8dfc-d72588b97b59	15
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	e04e7c84-59c8-4a1d-8dfc-d72588b97b59	15
606730	esomeprazole 40 MG Delayed Release Oral Capsule	SCD	e04e7c84-59c8-4a1d-8dfc-d72588b97b59	15
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	e04e7c84-59c8-4a1d-8dfc-d72588b97b59	15
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	e04e7c84-59c8-4a1d-8dfc-d72588b97b59	15
606730	esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule	SY	e04e7c84-59c8-4a1d-8dfc-d72588b97b59	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-2351-77	00378235177	90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2351-77)	2015-12-07	0000-00-00	No	No	Current
0378-2351-93	00378235193	30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2351-93)	2015-08-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Esomeprazole Magnesium	Mylan Pharmaceuticals Inc.	2023-11-15	HUMAN PRESCRIPTION DRUG LABEL	16
Esomeprazole Magnesium	Mylan Institutional Inc.	2023-02-08	HUMAN PRESCRIPTION DRUG LABEL	12
Esomeprazole Magnesium	NCS HealthCare of KY, Inc dba Vangard Labs	2019-07-17	HUMAN PRESCRIPTION DRUG LABEL	2