Esomeprazole magnesium

Product NDC: 50090-4639
Requested package NDC: 50090-4639-1
11-digit product format: 500904639
Labeler code: 50090
Product ID: 50090-4639_572fedcd-f9c0-47c8-9803-0d8587672052
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esomeprazole magnesium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA021153
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2017-10-01
Marketing end: 0000-00-00
Substance: ESOMEPRAZOLE MAGNESIUM
Active strength: 40 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	50090-4639	50090-4639-1	I	Inactivated by FDA		2026-08-03

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 1.

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
N021153-001	NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20
N021153-002	NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021153-001	AB
N021153-002	AB

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021153-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021153-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021153-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021153-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021153-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021153-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021153-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021153-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021153-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021153-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021153-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021153-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021153-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021153-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021153-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021153-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021153-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021153-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021153-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021153-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021153-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021153-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021153-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021153-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021153-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021153-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021153-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021153-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021153-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021153-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021153-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021153-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021153-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021153-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021153-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021153-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021153-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021153-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021153-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021153-001	6147103*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6166213*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6191148*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6428810	2019-11-03	U-729	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6428810	2019-11-03	U-770	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6428810	2019-11-03	U-469	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6428810*PED	2020-05-03		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6147103*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6166213*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6191148*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6428810	2019-11-03	U-770	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6428810	2019-11-03	U-729	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6428810	2019-11-03	U-469	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6428810*PED	2020-05-03		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021153-001	6428810*PED	2020-05-03		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021153-002	6428810*PED	2020-05-03		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021153-001	6428810*PED	2020-05-03		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021153-002	6428810*PED	2020-05-03		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6147103*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6166213*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6191148*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6428810	2019-11-03	U-729	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6428810	2019-11-03	U-770	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6428810	2019-11-03	U-469	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6428810*PED	2020-05-03		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6147103*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6166213*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6191148*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6428810	2019-11-03	U-770	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6428810	2019-11-03	U-729	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6428810	2019-11-03	U-469	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6428810*PED	2020-05-03		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6147103*PED	2019-04-09		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6166213*PED	2019-04-09		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6191148*PED	2019-04-09		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6428810	2019-11-03	U-729	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6428810	2019-11-03	U-770	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6428810	2019-11-03	U-469	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6428810*PED	2020-05-03		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-002	6147103*PED	2019-04-09		Pediatric extension	`b00525d2431f…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1	Product name	6	20251027
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
50090-4639-0	2023-01-30	C162847	48780-1	f386c64a-04ec-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use esomeprazole magnesium delayed-release capsules safely and effectively. See full prescribing information for esomeprazole magnesium delayed-release capsules. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)
50090-4639-1	2023-01-30	C162847	48780-1	f386c64a-04ec-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use esomeprazole magnesium delayed-release capsules safely and effectively. See full prescribing information for esomeprazole magnesium delayed-release capsules. ESOMEPRAZOLE MAGNESIUM 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
50090-4639-0	Esomeprazole magnesium	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30		5
50090-4639-1	Esomeprazole magnesium	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4639	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]	5	Legacy NDC, 2 package rows	20210417_34c76aa2-3cfc-4ee9-b4ce-674c13cd7182.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
NEXIUM	ESOMEPRAZOLE MAGNESIUM	AstraZeneca Pharmaceuticals LP	f4853677-1622-4037-688b-fdf533a11d96	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021153 application number: NDA021153

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
606730	esomeprazole magnesium 40 MG Delayed Release Oral Capsule	PSN	34c76aa2-3cfc-4ee9-b4ce-674c13cd7182	5
606730	esomeprazole 40 MG Delayed Release Oral Capsule	SCD	34c76aa2-3cfc-4ee9-b4ce-674c13cd7182	5
606730	esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule	SY	34c76aa2-3cfc-4ee9-b4ce-674c13cd7182	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4639-1	50090463901	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4639-1)	2019-10-22	0000-00-00	No	No	Current