Esomeprazole Magnesium

Product NDC: 69230-320
11-digit product format: 692300320
Labeler code: 69230
Product ID: 69230-320_3203036c-7c7d-04ac-e063-6394a90a132b
Type: HUMAN OTC DRUG
Nonproprietary name: Esomeprazole Magnesium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Camber Consumer Care Inc
Application: ANDA212507
Marketing category: ANDA
Marketing start: 2020-06-02
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
A212507-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2020-06-02

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	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212507-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2020-06-02	`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
d2554c3d-eb0b-4bf8-aebc-18be7b195c8e	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	SPL version
69230-320-31	Esomeprazole Magnesium	1 in 1 CARTON	CAPSULE, DELAYED RELEASE	1	5
69230-320-31	Esomeprazole Magnesium	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	5
69230-320-32	Esomeprazole Magnesium	2 in 1 CARTON	CAPSULE, DELAYED RELEASE	2	5
69230-320-32	Esomeprazole Magnesium	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	5
69230-320-33	Esomeprazole Magnesium	3 in 1 CARTON	CAPSULE, DELAYED RELEASE	3	5
69230-320-33	Esomeprazole Magnesium	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69230-320-31	EA - Each	69230-320	b6c4335e-6e47-44c7-8641-1cda75926ae8	1	2021-01-08
69230-320-32	EA - Each	69230-320	48091071-7734-4ee4-86b2-e6f21e256753	1	2021-01-08
69230-320-33	EA - Each	69230-320	5e3d8d4f-1608-4d97-a29b-d9d3d3689863	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69230-320	ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [CAMBER CONSUMER CARE INC]	5	Current NDC, Legacy NDC, 6 package rows	20250410_d2554c3d-eb0b-4bf8-aebc-18be7b195c8e.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RIOPAN	ESOMEPRAZOLE	OPMX LLC	4c37280d-25b6-ad2f-e063-6394a90a0b9d	2026-03-24	Warnings	Exact identifier application applno (ANDA): 212507 application number: ANDA212507
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Camber Consumer Care Inc	d2554c3d-eb0b-4bf8-aebc-18be7b195c8e	2025-04-05	Warnings	Exact identifier application applno (ANDA): 212507 application number: ANDA212507 ndc (product): 69230-320
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE	Allegiant Health	42fa9084-89db-45ad-8212-4eeb53659a98	2025-01-30	Warnings	Exact identifier application applno (ANDA): 212507 application number: ANDA212507

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	d2554c3d-eb0b-4bf8-aebc-18be7b195c8e	5
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	d2554c3d-eb0b-4bf8-aebc-18be7b195c8e	5
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	d2554c3d-eb0b-4bf8-aebc-18be7b195c8e	5
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	d2554c3d-eb0b-4bf8-aebc-18be7b195c8e	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69230-320-31	69230032031	1 BOTTLE in 1 CARTON (69230-320-31) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	1 bottle	2020-06-02	0000-00-00	No	No	Current
69230-320-32	69230032032	2 BOTTLE in 1 CARTON (69230-320-32) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	2 bottle	2020-06-02	0000-00-00	No	No	Current
69230-320-33	69230032033	3 BOTTLE in 1 CARTON (69230-320-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	3 bottle	2020-06-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC)	Camber Consumer Care Inc \| Hetero Labs Limited Unit III \| Annora Pharma Private Limited	2025-04-05	HUMAN OTC DRUG LABEL	5