Omeprazole

Product NDC: 70518-2295
Requested package NDC: 70518-2295-0
11-digit product format: 705182295
Labeler code: 70518
Product ID: 70518-2295_e6fcd6e1-1d13-60c0-e053-2995a90ac597
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA075757
Marketing category: ANDA
Marketing start: 2019-09-03
Marketing end: 0000-00-00
Substance: OMEPRAZOLE
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: 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	70518-2295	70518-2295-0	D	Discontinued by firm		2026-08-03

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
A075757-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28
A075757-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075757-001	AB
A075757-002	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	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`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	A075757-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075757-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075757-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075757-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075757-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075757-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075757-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075757-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075757-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075757-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075757-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075757-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075757-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075757-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075757-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075757-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075757-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075757-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075757-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075757-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075757-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075757-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075757-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075757-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075757-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075757-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075757-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075757-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075757-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075757-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075757-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075757-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075757-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075757-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075757-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075757-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075757-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075757-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075757-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075757-002	AB	1	`782e0a99824c…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	St. Mary's Medical Park Pharmacy	db9f071b-85f4-061f-e053-2995a90a3ff5	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	QPharma Inc	f6f6ad19-ff6a-7cd3-e053-6294a90ae1bf	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	f76c23d5-26b6-cfb2-e053-6294a90aea42	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	0fb314cb-6291-422c-98ff-24d8449992f6	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Chartwell RX, LLC	4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e	2025-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Sandoz Inc	516170d4-4913-4577-a2d2-f5c52d1e79c6	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Proficient Rx LP	ee0598a1-0e5e-40ff-ad88-b0adfc533ca0	2024-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	17664f71-154a-47c6-b83c-b349bbc8a98f	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Sandoz Inc	e4562da8-9d94-4417-9f80-c1ffd4247259	2023-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2295	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.]	13	Legacy NDC	20250311_50ba678e-98ee-44de-87d1-6dd6a1528c00.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KG60484QX9	OMEPRAZOLE	73590-58-6	OMEPRAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2295-0	70518229500	30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-2295-0)	2019-09-03	0000-00-00	No	No	Current