Esomeprazole strontium

Product NDC: 65162-957
Requested package NDC: 65162-957-03
11-digit product format: 651620957
Labeler code: 65162
Product ID: 65162-957_cbbffeaf-54d6-4ec4-a7e9-fc6315cd527d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esomeprazole strontium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: NDA202342
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2013-08-12
Marketing end: 0000-00-00
Substance: ESOMEPRAZOLE STRONTIUM
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: 2023-12-31
Current FDA listing: Historical FDA.report record

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	65162-957	65162-957-03	I	Inactivated by FDA		2026-08-17

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
N202342-001	ESOMEPRAZOLE STRONTIUM	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2013-08-06
N202342-002	ESOMEPRAZOLE STRONTIUM	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2013-08-06

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202342-001	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202342-002	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-08-06	`bb7c543d1eb4…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65162-957-03	2023-07-28	C162847	48780-1	0191ceaa-620b-198a-e063-dbdaa90aec3e	These highlights do not include all the information needed to use ESOMEPRAZOLE STRONTIUM safely and effectively. See full prescribing information for ESOMEPRAZOLE STRONTIUM. ESOMEPRAZOLE STRONTIUM delayed-release capsules for oral use Initial U.S. Approval: 1989 (omeprazole)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65162-957-03	Esomeprazole strontium	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-957-03	EA - Each	65162-957	a8fb4a63-6fb3-4112-b207-ba3038228a23	1	2014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESOMEPRAZOLE STRONTIUM	ACTIVE INGREDIENT	C5N25H3803	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	12
ESOMEPRAZOLE	ACTIVE MOIETY	N3PA6559FT	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	12
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	12
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	12
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	12
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	12
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	12
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	12
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	12
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	12
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	12
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	12
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	12
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	12
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	12
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-957	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS LLC]	17	Legacy NDC, 1 package rows	20221226_61a5a84e-0194-4f11-91f8-83d7ac404932.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 STRONTIUM	ESOMEPRAZOLE STRONTIUM	R2 Pharma, LLC	3c916d32-f9e9-1d15-e054-00144ff88e88	2016-09-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202342 application number: NDA202342

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C5N25H3803	ESOMEPRAZOLE STRONTIUM	934714-36-0	ESOMEPRAZOLE STRONTIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1810789	esomeprazole strontium 24.65 MG Delayed Release Oral Capsule	PSN	61a5a84e-0194-4f11-91f8-83d7ac404932	17
1810787	esomeprazole strontium 49.3 MG Delayed Release Oral Capsule	PSN	61a5a84e-0194-4f11-91f8-83d7ac404932	17
1810789	esomeprazole strontium 24.65 MG Delayed Release Oral Capsule	SCD	61a5a84e-0194-4f11-91f8-83d7ac404932	17
1810787	esomeprazole strontium 49.3 MG Delayed Release Oral Capsule	SCD	61a5a84e-0194-4f11-91f8-83d7ac404932	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-957-03	65162095703	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-957-03)	2013-08-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Esomeprazole strontium	Amneal Pharmaceuticals LLC \| Catalent Pharma Solutions, LLC	2021-01-25	HUMAN PRESCRIPTION DRUG LABEL	17