Omeprazole

Product NDC: 62175-114
11-digit product format: 621750114
Labeler code: 62175
Product ID: 62175-114_e786b865-dc62-4018-9cb1-7056b7ca2cde
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA075410
Marketing category: ANDA
Marketing start: 2003-09-03
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: 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
A075410-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01
A075410-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01
A075410-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075410-001	AB
A075410-002	AB
A075410-003	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	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`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	A075410-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075410-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075410-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075410-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075410-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075410-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075410-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075410-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075410-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075410-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075410-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075410-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075410-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075410-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075410-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075410-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075410-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075410-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075410-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075410-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075410-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075410-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075410-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075410-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075410-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075410-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075410-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075410-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075410-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075410-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075410-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075410-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075410-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075410-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075410-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075410-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075410-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075410-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075410-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075410-001	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	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 · 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
92201fb1-4570-42db-8da3-3b8c0e291d32	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62175-114-32	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	50
62175-114-37	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	50
62175-114-46	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	50
62175-114-49	Omeprazole	72000 in 1 DRUM	CAPSULE, DELAYED RELEASE	72000	50

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62175-114-32	EA - Each	62175-114	b3589406-936c-4307-b0e9-75fb2fbb07f1	1	2012-07-24
62175-114-37	EA - Each	62175-114	1c5c1975-21eb-4dad-a97b-27297fe19c91	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
ALUMINUM CHLOROHYDREX PROPYLENE GLYCOL	INACTIVE INGREDIENT	PGG6VG42HP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]	23
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
ALUMINUM CHLOROHYDREX PROPYLENE GLYCOL	INACTIVE INGREDIENT	PGG6VG42HP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	5
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
GLYCERYL BEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62175-114	OMEPRAZOLE CAPSULE, DELAYED RELEASE [LANNETT COMPANY, INC.]	50	Current NDC, Legacy NDC, 4 package rows	20230429_92201fb1-4570-42db-8da3-3b8c0e291d32.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Chartwell RX, LLC	10f5502a-2e63-4f2a-a3ba-ddc5bd403051	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	ed9895ae-3d18-434c-8b56-47bccdc8fe6d	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	ad675ef6-5377-b9f2-e053-2995a90a06e9	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	55a1fb3c-f040-2e39-e054-00144ff8d46c	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	8991d464-7abc-4350-e053-2995a90a4ea7	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	1318a1c1-222d-471a-92d6-3632c82fb999	2024-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	18f5a7cc-40d8-4aeb-a601-47bc9024f130	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Lannett Company, Inc.	92201fb1-4570-42db-8da3-3b8c0e291d32	2023-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410 ndc (product): 62175-114
Omeprazole	OMEPRAZOLE	Proficient Rx LP	9786b04f-f827-460b-91bc-c0ac967f95dd	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	4b188d97-f1b3-468d-9818-b8333bf24b5a	2020-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410

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	92201fb1-4570-42db-8da3-3b8c0e291d32	50
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	92201fb1-4570-42db-8da3-3b8c0e291d32	50
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	92201fb1-4570-42db-8da3-3b8c0e291d32	50
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	92201fb1-4570-42db-8da3-3b8c0e291d32	50
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	92201fb1-4570-42db-8da3-3b8c0e291d32	50
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	92201fb1-4570-42db-8da3-3b8c0e291d32	50
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	92201fb1-4570-42db-8da3-3b8c0e291d32	50
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	92201fb1-4570-42db-8da3-3b8c0e291d32	50
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	5aba19da-663f-4901-94e2-f438dba4841f	5
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	5aba19da-663f-4901-94e2-f438dba4841f	5
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	5aba19da-663f-4901-94e2-f438dba4841f	5
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	5aba19da-663f-4901-94e2-f438dba4841f	5
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	5aba19da-663f-4901-94e2-f438dba4841f	5
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	5aba19da-663f-4901-94e2-f438dba4841f	5
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	5aba19da-663f-4901-94e2-f438dba4841f	5
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	5aba19da-663f-4901-94e2-f438dba4841f	5
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	d58c0b66-475f-46b3-949d-cda5343e7239	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	d58c0b66-475f-46b3-949d-cda5343e7239	1
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	d58c0b66-475f-46b3-949d-cda5343e7239	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	d58c0b66-475f-46b3-949d-cda5343e7239	1
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	d58c0b66-475f-46b3-949d-cda5343e7239	1
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	d58c0b66-475f-46b3-949d-cda5343e7239	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62175-114-32	62175011432	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62175-114-32)	2003-09-03	0000-00-00	No	No	Current
62175-114-37	62175011437	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62175-114-37)	2003-09-03	0000-00-00	No	No	Current
62175-114-46	62175011446	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62175-114-46)	2003-09-03	0000-00-00	No	No	Current
62175-114-49	62175011449	72000 CAPSULE, DELAYED RELEASE in 1 DRUM (62175-114-49)	2003-09-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole	Lannett Company, Inc. \| Apace Packaging LLC	2023-04-21	HUMAN PRESCRIPTION DRUG LABEL	50
Omeprazole	Physicians Total Care, Inc.	2015-05-04	HUMAN PRESCRIPTION DRUG LABEL	5
Omeprazole	Rebel Distributors Corp.	2009-12-10	HUMAN PRESCRIPTION DRUG LABEL	1