Omeprazole

Product NDC: 82804-310
Requested package NDC: 82804-310-30
11-digit product format: 828040310
Labeler code: 82804
Product ID: 82804-310_062800b1-790a-41c3-a8be-94143d2c7fb6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA078490
Marketing category: ANDA
Marketing start: 2014-03-01
Substance: OMEPRAZOLE
Active strength: 10 mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078490-001	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17
A078490-002	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16
A078490-003	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078490-001	AB
A078490-002	AB
A078490-003	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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078490-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078490-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078490-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078490-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078490-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078490-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078490-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078490-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078490-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KG60484QX9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199119	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
062800b1-790a-41c3-a8be-94143d2c7fb6	Available on FDA.report

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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	REMEDYREPACK INC.	63b3982a-b541-4b0d-99d4-93a673e57d46	2026-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Proficient Rx LP	062800b1-790a-41c3-a8be-94143d2c7fb6	2026-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490 ndc (package): 82804-310-30 ndc (product): 82804-310 ndc11 (package): 82804031030
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	96104ea6-c08f-40b5-83f5-d840b317f1fd	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	0344268f-d8e6-48d5-b1e1-f750ed1d8a52	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	St. Mary's Medical Park Pharmacy	4c0cf466-f9e8-390e-e063-6294a90a2ed8	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	e07af8c9-559c-5a93-e053-2a95a90a2c63	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Dr. Reddy's Laboratories Limited	603d2d06-c5e8-4378-a422-8dca1a410af7	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	NorthStar Rx LLC	40a75dc7-49b7-5c9d-6c5f-d4682ec6922e	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	288bdd5e-a0ac-4c5c-abe0-93183a28dcdd	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	4720cc17-013e-074e-e063-6294a90ac1f4	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Redpharm Drug	2fd1acb8-12dc-70b7-e063-6394a90a0399	2025-12-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	American Health Packaging	205652e1-7fbc-4b6a-bbd6-2fd346d812df	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals, Inc.	28515ff8-379d-5356-e063-6394a90af3f3	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	3724b8f7-52ff-a5f8-e063-6294a90acf20	2025-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Quallent Pharmaceuticals Health LLC	8090d4c3-3184-7812-53d7-aa30e14b79d1	2025-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	PHOENIX RX LLC	3b19d724-821b-61dc-e063-6294a90aa4d3	2025-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Advanced Rx of Tennessee, LLC	30955530-56d2-174d-e063-6294a90a413c	2025-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	40f66cac-bc23-43f9-9966-87cce458c996	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	2dcd48e4-9ffc-9cc2-e063-6294a90ae17e	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Coupler LLC	2cdc6809-3b1b-046a-e063-6394a90ae02a	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490

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	Sample	Exclude flag	Status
82804-310-30	82804031030	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-310-30)	2026-08-19	No	No	Current