omeprazole

Product NDC: 31722-528
11-digit product format: 317220528
Labeler code: 31722
Product ID: 31722-528_2b439e93-9a24-e64a-e063-6394a90a634f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA204012
Marketing category: ANDA
Marketing start: 2019-09-26
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A204012-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-09-26
A204012-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2019-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204012-001	AB
A204012-002	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 · 84 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
2026-10-15 13:18:30	2026-09	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204012-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204012-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2019-09-26	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204012-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204012-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204012-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204012-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204012-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204012-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204012-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204012-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204012-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204012-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204012-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204012-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204012-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204012-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204012-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204012-002	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204012-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204012-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204012-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204012-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204012-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204012-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204012-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204012-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204012-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204012-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204012-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204012-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204012-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204012-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204012-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A204012-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204012-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A204012-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204012-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204012-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204012-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A204012-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204012-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A204012-002	AB	1	`e64feba35796…`

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	20 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198051	Internal RxNorm lookup
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
0c6e00a2-31e8-4e84-928d-80e69a5fc634	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
31722-528-01	omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100		2
31722-528-30	omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-528	OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20250110_0c6e00a2-31e8-4e84-928d-80e69a5fc634.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
omeprazole	OMEPRAZOLE	Camber Pharmaceuticals, Inc.	0c6e00a2-31e8-4e84-928d-80e69a5fc634	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204012 application number: ANDA204012 ndc (product): 31722-528

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	0c6e00a2-31e8-4e84-928d-80e69a5fc634	2
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	0c6e00a2-31e8-4e84-928d-80e69a5fc634	2
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	0c6e00a2-31e8-4e84-928d-80e69a5fc634	2
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	0c6e00a2-31e8-4e84-928d-80e69a5fc634	2
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	0c6e00a2-31e8-4e84-928d-80e69a5fc634	2
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	0c6e00a2-31e8-4e84-928d-80e69a5fc634	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-528-01	31722052801	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-528-01)	2019-09-26	0000-00-00	No	No	Current
31722-528-30	31722052830	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-528-30)	2019-09-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
omeprazole	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit III	2025-01-09	HUMAN PRESCRIPTION DRUG LABEL	2