ESOMEPRAZOLE STRONTIUM

Product NDC: 70849-200
11-digit product format: 708490200
Labeler code: 70849
Product ID: 70849-200_3d19523d-7cb5-2f2f-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: esomeprazole strontium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: R2 Pharma, LLC
Application: NDA202342
Marketing category: NDA
Marketing start: 2016-09-15
Substance: ESOMEPRAZOLE STRONTIUM
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 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: ESOMEPRAZOLE STRONTIUM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESOMEPRAZOLE STRONTIUM	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C5N25H3803	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1810787	Internal RxNorm lookup
1810789	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
3c916d32-f9e9-1d15-e054-00144ff88e88	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	Strength	SPL version
70849-200-30	ESOMEPRAZOLE STRONTIUM	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70849-200-30	EA - Each	70849-200	253bc690-6c1e-48df-a015-7ced264daf9f	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70849-200	ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE [R2 PHARMA, LLC]	2	Current NDC, Legacy NDC, 1 package rows	20161102_3c916d32-f9e9-1d15-e054-00144ff88e88.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 ndc (product): 70849-200

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	3c916d32-f9e9-1d15-e054-00144ff88e88	2
1810787	esomeprazole strontium 49.3 MG Delayed Release Oral Capsule	PSN	3c916d32-f9e9-1d15-e054-00144ff88e88	2
1810789	esomeprazole strontium 24.65 MG Delayed Release Oral Capsule	SCD	3c916d32-f9e9-1d15-e054-00144ff88e88	2
1810787	esomeprazole strontium 49.3 MG Delayed Release Oral Capsule	SCD	3c916d32-f9e9-1d15-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70849-200-30	70849020030	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70849-200-30)	2016-09-15	0000-00-00	No	No	Current