Omeprazole

Product NDC: 70518-2295
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-2295		D	Discontinued by firm	2026-08-03
excluded package	package	70518-2295	70518-2295-0	D	Discontinued by firm	2026-08-03
excluded package	package	70518-2295	70518-2295-1	D	Discontinued by firm	2026-08-03
excluded package	package	70518-2295	70518-2295-2	D	Discontinued by firm	2026-08-03
excluded package	package	70518-2295	70518-2295-3	D	Discontinued by firm	2026-08-03
excluded package	package	70518-2295	70518-2295-4	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 2 · 64 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
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…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2003-01-28	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075757-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075757-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075757-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075757-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075757-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075757-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075757-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075757-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075757-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075757-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075757-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075757-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075757-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075757-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075757-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075757-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075757-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075757-002	AB	1	`1c564ffb4f44…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
70518-2295-1	70518229501	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2295-1)	2022-08-23	0000-00-00	No	No	Current