ESOMEPRAZOLE MAGNESIUM

Product NDC: 69618-073
11-digit product format: 696180073
Labeler code: 69618
Product ID: 69618-073_7b9c7db0-8cc4-4e45-9715-69be0c208ca5
Type: HUMAN OTC DRUG
Nonproprietary name: ESOMEPRAZOLE MAGNESIUM
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Reliable 1 Laboratories LLC
Application: ANDA216349
Marketing category: ANDA
Marketing start: 2023-04-14
Substance: ESOMEPRAZOLE MAGNESIUM
Active strength: 20 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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216349-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2022-06-24

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216349-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-06-24	`a50c72e98297…`

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	20 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
606726	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
15d2c4f7-5b20-4c7c-b2a6-9baed7bf39cf	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
69618-073-42	ESOMEPRAZOLE MAGNESIUM	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14		1
69618-073-42	ESOMEPRAZOLE MAGNESIUM	3 in 1 CARTON	CAPSULE, DELAYED RELEASE	3		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69618-073-42	EA - Each	69618-073	b15c8305-c84e-48df-b24c-bf6819cb0c41	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69618-073	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [RELIABLE 1 LABORATORIES LLC]	1	Current NDC, 2 package rows	20230416_15d2c4f7-5b20-4c7c-b2a6-9baed7bf39cf.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	Rising Pharma Holdings, Inc.	2164e1d7-e601-4ce5-be29-0c21c3a5a647	2026-04-16		Exact identifier application applno (ANDA): 216349 application number: ANDA216349
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	GLENMARK THERAPEUTICS INC., USA	da5ec2c4-833e-4d2a-a61f-b43835c7f473	2026-01-23	Warnings	Exact identifier application applno (ANDA): 216349 application number: ANDA216349
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	GLENMARK THERAPEUTICS INC., USA	ff233fbb-716d-4879-811c-c8d82e3c99ce	2023-05-25		Exact identifier application applno (ANDA): 216349 application number: ANDA216349
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	Rising Pharma Holdings, Inc.	07ba5747-702f-47fc-9d80-5a70296b64bf	2023-05-11		Exact identifier application applno (ANDA): 216349 application number: ANDA216349
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	Reliable 1 Laboratories LLC	15d2c4f7-5b20-4c7c-b2a6-9baed7bf39cf	2023-04-15		Exact identifier application applno (ANDA): 216349 application number: ANDA216349 ndc (product): 69618-073

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	15d2c4f7-5b20-4c7c-b2a6-9baed7bf39cf	1
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	15d2c4f7-5b20-4c7c-b2a6-9baed7bf39cf	1
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	15d2c4f7-5b20-4c7c-b2a6-9baed7bf39cf	1
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	15d2c4f7-5b20-4c7c-b2a6-9baed7bf39cf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69618-073-42	69618007342	3 BOTTLE in 1 CARTON (69618-073-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	3 bottle	2023-04-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg	Reliable 1 Laboratories LLC \| Graviti Pharmaceuticals Private Limited	2023-04-15	HUMAN OTC DRUG LABEL	1