Omeprazole

Product NDC: 57237-161
11-digit product format: 572370161
Labeler code: 57237
Product ID: 57237-161_aec12e35-60fb-416c-a2d0-a87cfdcb30a6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA203270
Marketing category: ANDA
Marketing start: 2015-08-19
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203270-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19
A203270-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19
A203270-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203270-001	AB
A203270-002	AB
A203270-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203270-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203270-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203270-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203270-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203270-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203270-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203270-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203270-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203270-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203270-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203270-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203270-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203270-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203270-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203270-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203270-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole
Listing expiration: 2026-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198051	Internal RxNorm lookup
199119	Internal RxNorm lookup
200329	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
a1b1c61b-d4fe-433d-ad31-0b11758976fa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
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	SPL version
57237-161-01	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	14
57237-161-30	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	14
57237-161-50	Omeprazole	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	14
57237-161-90	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	14
57237-161-99	Omeprazole	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-161-01	EA - Each	57237-161	203cf79d-2933-4626-a533-a9553d4c76f2	1	2016-06-14
57237-161-30	EA - Each	57237-161	d64f2486-57d9-4fd0-8fb1-daa3cc51bfb7	1	2016-06-14
57237-161-90	EA - Each	57237-161	2133e61f-d252-4752-92ae-cabaea4d5763	1	2017-07-07
57237-161-99	EA - Each	57237-161	2b5a842f-883a-4f1e-8636-1a7af1695169	1	2016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-161	OMEPRAZOLE CAPSULE, DELAYED RELEASE [RISING PHARMA HOLDINGS, INC.]	14	Current NDC, Legacy NDC, 5 package rows	20241115_a1b1c61b-d4fe-433d-ad31-0b11758976fa.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	QPharma Inc	50115204-74f7-17c1-e063-6394a90ab665	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Preferred Phharmaceuticals Inc.	319d990e-161b-4c16-b026-f55c413c7e8f	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Proficient Rx LP	61eab342-61fd-471f-8f70-95f9cbca0097	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	c1276463-7357-45b5-9f7e-8d3c4a550ff4	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	df1a4294-3893-4a11-b4d5-f3536678087e	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	af707c0a-5193-3f83-e053-2995a90a78ef	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	10a3fbc9-00c6-ad83-e063-6294a90ae1ad	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	f3038133-8bb2-044e-e053-2995a90a6e7d	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	QPharma, Inc.	f5dd5d63-1376-1ff7-e053-2a95a90a1d94	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	40b4e1b6-f64d-44d5-bfc2-0cb8f78d9e67	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	064b1418-0f42-4b18-9dee-cda40c5e1fca	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	c311c1b9-8ec2-4ac0-baa2-a5063fba2d80	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Rising Pharma Holdings, Inc.	a1b1c61b-d4fe-433d-ad31-0b11758976fa	2024-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270 ndc (product): 57237-161
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	fe7d3352-d53f-4046-92ed-1eb5c917fbee	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	8d925ca6-83f1-4263-8218-4bf7cc8ceb39	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	9378c870-f2cc-4a60-b0fd-08a4d43857bc	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Aurobindo Pharma Limited	934601b6-fbba-43c4-a8ef-7a7dfe9f9a51	2024-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270

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
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	064b1418-0f42-4b18-9dee-cda40c5e1fca	107
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	064b1418-0f42-4b18-9dee-cda40c5e1fca	107
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	064b1418-0f42-4b18-9dee-cda40c5e1fca	107
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	a1b1c61b-d4fe-433d-ad31-0b11758976fa	14
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	a1b1c61b-d4fe-433d-ad31-0b11758976fa	14
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	a1b1c61b-d4fe-433d-ad31-0b11758976fa	14
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	a1b1c61b-d4fe-433d-ad31-0b11758976fa	14
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	a1b1c61b-d4fe-433d-ad31-0b11758976fa	14
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	a1b1c61b-d4fe-433d-ad31-0b11758976fa	14
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	a1b1c61b-d4fe-433d-ad31-0b11758976fa	14
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	a1b1c61b-d4fe-433d-ad31-0b11758976fa	14
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	10a3fbc9-00c6-ad83-e063-6294a90ae1ad	4
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	af707c0a-5193-3f83-e053-2995a90a78ef	4
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	5048b657-38e4-22f7-e054-00144ff8d46c	4
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	af707c0a-5193-3f83-e053-2995a90a78ef	4
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	5048b657-38e4-22f7-e054-00144ff8d46c	4
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	10a3fbc9-00c6-ad83-e063-6294a90ae1ad	4
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	5048b657-38e4-22f7-e054-00144ff8d46c	4
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	af707c0a-5193-3f83-e053-2995a90a78ef	4
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	10a3fbc9-00c6-ad83-e063-6294a90ae1ad	4
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	319d990e-161b-4c16-b026-f55c413c7e8f	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	26a82fb0-7b6b-0839-e063-6394a90a9302	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	23a03524-a45b-ad06-e063-6394a90aec13	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	319d990e-161b-4c16-b026-f55c413c7e8f	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	26a82fb0-7b6b-0839-e063-6394a90a9302	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	23a03524-a45b-ad06-e063-6394a90aec13	1
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	319d990e-161b-4c16-b026-f55c413c7e8f	1
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	26a82fb0-7b6b-0839-e063-6394a90a9302	1
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	23a03524-a45b-ad06-e063-6394a90aec13	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-161-01	57237016101	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-01)	2015-08-19	0000-00-00	No	No	Current
57237-161-30	57237016130	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-30)	2015-08-19	0000-00-00	No	No	Current
57237-161-50	57237016150	500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-50)	2015-08-19	0000-00-00	No	No	Current
57237-161-90	57237016190	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-90)	2015-08-19	0000-00-00	No	No	Current
57237-161-99	57237016199	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-161-99)	2015-08-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole	QPharma Inc \| Aurobindo Pharma Limited \| Northwind Health Company, LLC	2026-06-08	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	Preferred Phharmaceuticals Inc.	2026-04-21	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	NuCare Pharmaceuticals,Inc.	2026-03-11	HUMAN PRESCRIPTION DRUG LABEL	4
Omeprazole	Northwind Health Company, LLC	2026-01-05	HUMAN PRESCRIPTION DRUG LABEL	4
Omeprazole	Bryant Ranch Prepack	2024-12-11	HUMAN PRESCRIPTION DRUG LABEL	107
Omeprazole	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-11-12	Human Prescription Drug Label	14
Omeprazole	Coupler LLC	2024-11-11	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	Redpharm Drug	2024-10-04	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	REMEDYREPACK INC.	2024-07-30	HUMAN PRESCRIPTION DRUG LABEL	10
Omeprazole - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-21	HUMAN PRESCRIPTION DRUG LABEL	4
Omeprazole	Preferred Pharmaceuticals, Inc.	2020-08-07	HUMAN PRESCRIPTION DRUG LABEL	2
Omeprazole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2019-05-20	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	A-S Medication Solutions	2018-05-09	Human Prescription Drug Label	1
Omeprazole	NuCare Pharmaceuticals,Inc.	2017-07-18	HUMAN PRESCRIPTION DRUG LABEL	1