topcare esomeprazole magnesium

Product NDC: 36800-627
11-digit product format: 368000627
Labeler code: 36800
Product ID: 36800-627_61351d9f-87dd-4586-a46a-9ab7fabe41ce
Type: HUMAN OTC DRUG
Nonproprietary name: esomeprazole magnesium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Topco Associates LLC
Application: ANDA207193
Marketing category: ANDA
Marketing start: 2020-03-12
Substance: ESOMEPRAZOLE MAGNESIUM DIHYDRATE
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
A207193-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2017-08-18

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 2 · 41 observed 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	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: topcare esomeprazole magnesium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
36H71644EQ	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
86384845-0bea-490b-b04a-5770ef88b639	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
36800-627-01	topcare esomeprazole magnesium	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	5
36800-627-01	topcare esomeprazole magnesium	1 in 1 CARTON	CAPSULE, DELAYED RELEASE	1	5
36800-627-03	topcare esomeprazole magnesium	3 in 1 CARTON	CAPSULE, DELAYED RELEASE	3	5
36800-627-03	topcare esomeprazole magnesium	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-627	TOPCARE ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC]	5	Current NDC, Legacy NDC, 4 package rows	20240905_86384845-0bea-490b-b04a-5770ef88b639.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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ESOMEPRAZOLE MAGNESIUM MINIS	ESOMEPRAZOLE MAGNESIUM DIHYDRATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	c1435a38-b816-45a1-a0f6-4ad0c5b6da58	2026-07-27	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
esomeprazole magnesium	ESOMEPRAZOLE	Rite Aid Corporation	6996642f-a63e-4be9-aefd-0634e9914c2b	2026-07-07	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
Basic Care Esomeprazole Magnesium	ESOMEPRAZOLE	Amazon.com Services LLC	42dd2e93-776c-4f49-b590-afc7dab6ef2f	2026-06-17	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
good sense esomeprazole magnesium	ESOMEPRAZOLE	L. Perrigo Company	f13088de-6841-453e-acb0-08bbdf9529d1	2026-05-20	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM DIHYDRATE	HyVee Inc	c2308fc8-1549-476d-9769-2991051360ad	2026-03-24	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
EQUATE ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE	WALMART INC.	ce5f2915-327d-4a91-b7fd-e399664a250f	2026-03-19	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
Foster and Thrive Acid Reducer	ESOMEPRAZOLE	Strategic Sourcing Services LLC	32933772-c0ef-46ad-84e5-d70218bcc866	2026-03-07	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM DIHYDRATE	Walgreen Company	29eb7b87-59a4-4d27-ad53-789da7fec427	2026-02-28	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
members mark esomeprazole magnesium	ESOMEPRAZOLE	Sam's West Inc	87913038-4b90-40a0-bce5-2d368bd5758c	2026-02-07	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
esomeprazole magnesium	ESOMEPRAZOLE	HyVee Inc	b0968243-171e-428a-b692-740e0c05a0fc	2026-01-29	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
equate esomeprazole magnesium	ESOMEPRAZOLE	Wal-Mart Stores Inc	aaafc536-f846-4019-a629-b52b3f36e682	2026-01-19	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
berkley and jensen heartburn treatment	ESOMEPRAZOLE	BJWC	2369c948-d46f-4ace-bc51-47477631bc43	2026-01-19	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
careone esomeprazole magnesium	ESOMEPRAZOLE	American Sales Company	3f9a2747-8afd-4898-bbfb-5f379293137e	2025-11-03	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
Esomeprazole Magnesium	ESOMEPRAZOLE	Publix Super Markets Inc	60554fd6-96d5-4e73-b676-332116caa800	2025-09-29	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
equate esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM DIHYDRATE	WALMART INC.	2d40c4bf-5b66-420c-9f17-3f31edc40d1a	2025-09-11	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
Up and Up Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Target Corporation	b3d3ad1d-96f8-4f72-ae66-f14940a62882	2025-06-02	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
leader esomeprazole magnesium	ESOMEPRAZOLE	Cardinal Health 110, LLC. dba Leader	c9472b82-d345-4531-bf07-bd55c94876ab	2025-04-23	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
esomeprazole magnesium	ESOMEPRAZOLE	CVS Pharmacy	6f1d75c1-3c0d-41c2-a625-1ee1bf642c32	2025-01-11	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
topcare esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Topco Associates LLC	86384845-0bea-490b-b04a-5770ef88b639	2024-09-01	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193 ndc (product): 36800-627
Good Sense Esomeprazole Magnesium	ESOMEPRAZOLE	L. Perrigo Company	4a89b4b5-5c42-44ee-98a9-e26a237aaef7	2024-08-27	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
36H71644EQ	ESOMEPRAZOLE MAGNESIUM DIHYDRATE	217087-10-0	ESOMEPRAZOLE MAGNESIUM DIHYDRATE
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	86384845-0bea-490b-b04a-5770ef88b639	5
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	86384845-0bea-490b-b04a-5770ef88b639	5
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	86384845-0bea-490b-b04a-5770ef88b639	5
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	86384845-0bea-490b-b04a-5770ef88b639	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-627-01	36800062701	1 BOTTLE in 1 CARTON (36800-627-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	1 bottle	2020-03-12	0000-00-00	No	No	Current
36800-627-03	36800062703	3 BOTTLE in 1 CARTON (36800-627-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	3 bottle	2020-03-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Esomeprazole Magnesium Drug Facts	Topco Associates LLC	2024-09-01	HUMAN OTC DRUG LABEL	5