Omeprazole

Product NDC: 64861-303
11-digit product format: 648610303
Labeler code: 64861
Product ID: 64861-303_5b97f373-690c-4a84-b3f6-24353f50f771
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Dexcel Ltd.
Application: NDA022032
Marketing category: NDA
Marketing start: 2008-03-01
Marketing end: 0000-00-00
Substance: OMEPRAZOLE
Active strength: 20 mg/1
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	64861-303-03
excluded package	package	64861-303-01
excluded package	package	64861-303-02

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022032-001	OMEPRAZOLE	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2007-12-04

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022032-001	12599565	2030-01-31		Drug product	2026-05-11

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022032-001	12599565	2030-01-31	Drug product	2026-05-11	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022032-001	12599565	2030-01-31	Drug product	2026-05-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022032-001	12599565	2030-01-31	Drug product	2026-05-11	`caaa826d4ba7…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
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
424daadb-95de-8ece-97f5-235e3f7f0001	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64861-303-01	2020-02-12	Omeprazole Delayed Release Tablets, 20 mg
64861-303-02	2020-02-12	Omeprazole Delayed Release Tablets, 20 mg
64861-303-03	2020-02-12	Omeprazole Delayed Release Tablets, 20 mg
64861-303-01	2020-01-31	Omeprazole Delayed Release Tablets, 20 mg
64861-303-02	2020-01-31	Omeprazole Delayed Release Tablets, 20 mg
64861-303-03	2020-01-31	Omeprazole Delayed Release Tablets, 20 mg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]	3
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]	3
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)	INACTIVE INGREDIENT	36BGF0E889	OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]	3
MONOETHANOLAMINE	INACTIVE INGREDIENT	5KV86114PT	OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]	3
SODIUM STEARATE	INACTIVE INGREDIENT	QU7E2XA9TG	OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]	3
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]	3
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
Omeprazole	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DEXCEL LTD.]	1
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
Omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DEXCEL LTD.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	OMEPRAZOLE TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
Carnauba Wax	INACTIVE INGREDIENT	R12CBM0EIZ	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DEXCEL LTD.]	1
ETHANOLAMINE	INACTIVE INGREDIENT	5KV86114PT	OMEPRAZOLE TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
Ethanolamine	INACTIVE INGREDIENT	5KV86114PT	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DEXCEL LTD.]	1
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DEXCEL LTD.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DEXCEL LTD.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
Hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DEXCEL LTD.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
Hypromellose Acetate Succinate 12070923 (3 MM2/S)	INACTIVE INGREDIENT	36BGF0E889	OMEPRAZOLE TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
Hypromellose Acetate Succinate 12070923 (3 MM2/S)	INACTIVE INGREDIENT	36BGF0E889	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DEXCEL LTD.]	1
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DEXCEL LTD.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OMEPRAZOLE TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DEXCEL LTD.]	1
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DEXCEL LTD.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	OMEPRAZOLE TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
Sodium Starch Glycolate Type A Potato	INACTIVE INGREDIENT	5856J3G2A2	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DEXCEL LTD.]	1
SODIUM STEARATE	INACTIVE INGREDIENT	QU7E2XA9TG	OMEPRAZOLE TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
Sodium Stearate	INACTIVE INGREDIENT	QU7E2XA9TG	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DEXCEL LTD.]	1
Sodium Stearyl Fumarate	INACTIVE INGREDIENT	7CV7WJK4UI	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DEXCEL LTD.]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	OMEPRAZOLE TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DEXCEL LTD.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DEXCEL LTD.]	1
Triethyl Citrate	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DEXCEL LTD.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1

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 3 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TopCare Omeprazole delayed release	OMEPRAZOLE	Topco Associates LLC	8ed57521-e69a-4563-9ce2-4f6d667f065d	2024-08-30	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
basic care omeprazole	OMEPRAZOLE	Amazon.com Services LLC	73c36634-a70f-4641-910f-6cdda7fbcd36	2024-08-08	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
topcare omeprazole	OMEPRAZOLE	Topco Associates LLC	ec9d8dab-480c-49bc-bdbb-bebcc7676d01	2024-08-06	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
up and up omeprazole	OMEPRAZOLE	Target Corporation	2f2b26fe-dbc2-4185-8a27-6b166dd49ba2	2024-07-26	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
up and up omeprazole	OMEPRAZOLE	Target Corporation	7dc339da-e90b-452b-b25e-8d7f3aa8bc18	2024-07-20	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
good sense omeprazole delayed release	OMEPRAZOLE	L. Perrigo Company	38082e59-c509-4be5-b29c-33a97565df1c	2024-06-27	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
members mark omeprazole	OMEPRAZOLE	Sam's West Inc	0edfa800-fb14-44dd-9c31-de930b864ef9	2024-06-25	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
basic care omeprazole	OMEPRAZOLE	Amazon.com Services LLC	76b941f0-a02f-43e8-821e-09ccf675d944	2024-06-17	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
good neighbor pharmacy omeprazole	OMEPRAZOLE	Amerisource Bergen	5ee3cb79-5c0c-456f-b5d5-d5a008bbd118	2024-04-26	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	Publix Super Markets Inc	05fae639-ba68-4c05-8ca7-7c5cc2d50584	2024-04-16	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
Omeprazole	OMEPRAZOLE	Kroger Company	236a9447-23ec-44c7-a241-20f9ddc83ab8	2024-03-25	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
Good Sense Omeprazole	OMEPRAZOLE	L. Perrigo Company	db333c49-2c3e-4ade-a202-7d4499205fc4	2024-03-24	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
members mark omeprazole	OMEPRAZOLE	Sam's West Inc	907e9974-46b8-4dae-be92-518c076cb98f	2024-03-07	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	Walgreen Company	b7972f17-4a63-4d78-a181-01ea6d7d3963	2024-03-04	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
foster and thrive omeprazole	OMEPRAZOLE	Strategic Sourcing Services LLC	836efc63-b633-497c-ab56-76bb495bd723	2024-02-20	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
equaline omeprazole	OMEPRAZOLE	United Natural Foods, Inc. dba UNFI	b6c87a6a-253a-4455-9b7d-62f506da592e	2023-08-02	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	Walgreen Company	87cee50d-4c1e-473d-9d70-b1622f84aee1	2023-03-17	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032

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
402014	omeprazole 20 MG Delayed Release Oral Tablet	PSN	bb7e658c-dab5-43b3-b5c2-578948164e63	3
402014	omeprazole 20 MG Delayed Release Oral Tablet	SCD	bb7e658c-dab5-43b3-b5c2-578948164e63	3
402014	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet	SY	bb7e658c-dab5-43b3-b5c2-578948164e63	3
402014	omeprazole 20 MG Delayed Release Oral Tablet	PSN	61e72875-8de3-4da9-a6b9-3357189e6537	1
402014	omeprazole 20 MG Delayed Release Oral Tablet	SCD	61e72875-8de3-4da9-a6b9-3357189e6537	1
402014	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet	SY	61e72875-8de3-4da9-a6b9-3357189e6537	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole Delayed Release Tablets, 20 mg	Weeks & Leo Co., Inc.	2012-10-10	HUMAN OTC DRUG LABEL	3
Omeprazole Delayed Release Tablets, 20 mg	Physicians Total Care, Inc.	2010-04-27	HUMAN OTC DRUG LABEL	1
Omeprazole Delayed Release Tablets, 20 mg	Dexcel Ltd.	2010-04-27	HUMAN OTC DRUG LABEL	1