careone esomeprazole magnesium

Product NDC: 41520-727
11-digit product format: 415200727
Labeler code: 41520
Product ID: 41520-727_96c2b7f1-ae2c-4b41-b58a-183b654a70ff
Type: HUMAN OTC DRUG
Nonproprietary name: Esomeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: American Sales Company
Application: ANDA207193
Marketing category: ANDA
Marketing start: 2017-09-26
Substance: ESOMEPRAZOLE
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	41520-727	41520-727-02	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	41520-727	41520-727-02	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207193-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2017-08-18	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESOMEPRAZOLE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N3PA6559FT	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
3f9a2747-8afd-4898-bbfb-5f379293137e	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
41520-727-01	careone esomeprazole magnesium	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	5
41520-727-01	careone esomeprazole magnesium	1 in 1 CARTON	CAPSULE, DELAYED RELEASE	1	5
41520-727-02	careone esomeprazole magnesium	2 in 1 CARTON	CAPSULE, DELAYED RELEASE	2	5
41520-727-02	careone esomeprazole magnesium	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	5
41520-727-03	careone esomeprazole magnesium	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	5
41520-727-03	careone esomeprazole magnesium	3 in 1 CARTON	CAPSULE, DELAYED RELEASE	3	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-727	CAREONE ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERICAN SALES COMPANY]	4	Current NDC, Legacy NDC, 6 package rows	20191220_3f9a2747-8afd-4898-bbfb-5f379293137e.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 2 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	CVS Pharmacy	dcaaf24a-0fb9-41b9-881a-00fa60796ca9	2024-08-06	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Meijer Distribution Inc	1dd30fec-15f4-44b2-a38f-e59ff4da206d	2024-08-06	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
DG Health Esomeprazole Magnesium	ESOMEPRAZOLE	Dolgencorp Inc	2b0e555d-3ed5-4ec4-82a6-855351c503b3	2024-08-02	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
dg health esomeprazole magnesium	ESOMEPRAZOLE	Dolgencorp, LLC	8f974698-ce9c-4ffb-b77e-9bad2c2ee2a1	2024-08-01	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
up and up esomeprazole magnesium	ESOMEPRAZOLE	Target Corporation	717e5d5b-4bf7-415e-b259-44056bc96d8b	2024-08-01	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
kirkland signature esomeprazole magnesium	ESOMEPRAZOLE	Costco Wholesale Company	4a87d5d5-c98b-4dc5-81be-50183342b047	2024-08-01	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
Good Neighbor Pharmacy Esomeprazole Magnesium	ESOMEPRAZOLE	Amerisource Bergen	b596055c-98b2-47b1-b174-ae7ad3ba97ee	2024-07-30	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
Exchange Select Esomeprazole Magnesium	ESOMEPRAZOLE	Army & Air Force Exchange Service	5fa9089f-90d1-48b6-bb79-c6171eeeaa03	2024-07-26	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
signature care esomeprazole magnesium	ESOMEPRAZOLE	Safeway	238b27e3-6993-4213-b7eb-062309398d1b	2024-07-26	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
good sense esomeprazole magnesium	ESOMEPRAZOLE	L. Perrigo Company	e54f2cc9-1d5f-4f0a-8bcf-bd5b917d98ec	2024-07-26	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
Esomeprazole Magnesium	ESOMEPRAZOLE	H E B	0d08dd06-8df6-43ff-9033-8eebd215bec1	2024-07-26	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
signature care esomeprazole magnesium	ESOMEPRAZOLE	Safeway	972bb479-7146-454d-ace4-f9314f0e584e	2024-07-26	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
basic care esomeprazole magnesium	ESOMEPRAZOLE	Amazon.com Services LLC	0b115351-318c-4bd9-935c-704a09bcdf52	2024-07-25	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
esomeprazole magnesium	ESOMEPRAZOLE	Kroger Company	da02c079-ed18-4896-896d-0489c8f43554	2024-07-25	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
esomeprazole magnesium	ESOMEPRAZOLE	Meijer Distribution Inc	126c269b-260d-40f4-879d-169c09251c67	2024-07-25	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193
dg health esomeprazole magnesium	ESOMEPRAZOLE	Dolgencorp Inc	d5a842f3-d21b-4ddf-87f1-e44daf5cfe05	2024-05-08	Warnings	Exact identifier application applno (ANDA): 207193 application number: ANDA207193

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N3PA6559FT	ESOMEPRAZOLE	119141-88-7	ESOMEPRAZOLE

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	3f9a2747-8afd-4898-bbfb-5f379293137e	5
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	3f9a2747-8afd-4898-bbfb-5f379293137e	5
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	3f9a2747-8afd-4898-bbfb-5f379293137e	5
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	3f9a2747-8afd-4898-bbfb-5f379293137e	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-727-01	41520072701	1 BOTTLE in 1 CARTON (41520-727-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	1 bottle	2017-10-13	0000-00-00	No	No	Current
41520-727-02	41520072702	2 BOTTLE in 1 CARTON (41520-727-02) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	2 bottle	2017-11-13	0000-00-00	No	No	Current
41520-727-03	41520072703	3 BOTTLE in 1 CARTON (41520-727-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	3 bottle	2017-09-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
American Sales Company Esomeprazole Magnesium Drug Facts	American Sales Company	2025-11-03	HUMAN OTC DRUG LABEL	5