Omeprazole

Product NDC: 68462-397
11-digit product format: 684620397
Labeler code: 68462
Product ID: 68462-397_69b1e229-f845-4608-be48-f97e8d3e2273
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA091672
Marketing category: ANDA
Marketing start: 2014-10-31
Substance: OMEPRAZOLE
Active strength: 40 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 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	RLD / RS	Approval date
A091672-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31
A091672-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2014-10-31
A091672-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2014-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091672-001	AB
A091672-002	AB
A091672-003	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2014-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2014-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`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	A091672-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091672-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091672-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091672-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091672-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091672-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091672-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091672-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091672-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091672-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091672-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091672-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091672-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091672-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091672-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091672-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091672-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091672-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091672-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091672-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091672-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091672-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091672-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091672-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091672-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091672-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091672-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091672-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091672-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091672-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091672-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091672-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091672-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091672-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091672-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091672-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091672-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091672-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091672-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091672-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	40 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
c6c22be1-659d-4e71-b292-701e27da201b	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
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
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
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
68462-397-01	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	14
68462-397-10	Omeprazole	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	14
68462-397-30	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	14
68462-397-90	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-397-01	EA - Each	68462-397	0e23cb68-c0fe-4923-8e4d-0157b1e36605	1	2016-10-06
68462-397-10	EA - Each	68462-397	6e3028ee-51ad-4338-b796-e371e88e60eb	1	2016-10-06
68462-397-30	EA - Each	68462-397	1795df57-f120-4dfe-aeb5-515014491225	1	2016-10-06
68462-397-90	EA - Each	68462-397	a16948ec-4813-4062-92ed-5814bcef15fa	1	2016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-397	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]	13	Current NDC, Legacy NDC, 4 package rows	20230429_c6c22be1-659d-4e71-b292-701e27da201b.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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	REMEDYREPACK INC.	a19ce586-59b7-4c2e-9e8d-12e8f0f058e2	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	HAWAII REPACK, INC.	9359e826-5263-44fc-8dd3-9d0852fe42d6	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	dcaadc8c-32d1-476f-b821-973c012b7fa7	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	Unit Dose Solutions, Inc.	557d4c2c-5541-3a51-e063-6394a90ad278	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	REMEDYREPACK INC.	d9b3918c-a66e-4277-8b8f-b7ece93fa7db	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	ST. MARY'S MEDICAL PARK PHARMACY	4f5c91e6-6377-ca94-e063-6294a90a2f99	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole DR	OMEPRAZOLE	Advanced Rx Pharmacy of Tennessee, LLC	c8bf92c9-1bab-7985-e053-2995a90a0225	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	Glenmark Pharmaceuticals Inc., USA	c6c22be1-659d-4e71-b292-701e27da201b	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672 ndc (product): 68462-397
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	fa0395a7-4353-4d64-9de8-d15857a7031c	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	17ccdbe0-19c1-498d-8e81-578be549b4e5	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	aa8fc2ea-3942-453b-bc19-1e4b14ba6926	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	3d6e07d1-38b1-f2ab-e063-6294a90a34ac	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	bab55f83-ba03-49a0-842a-19c9976b7fe8	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	5bda70ae-c3f6-450b-892f-6814795dd6ca	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	PHOENIX RX LLC	3a9baece-03be-6c77-e063-6394a90a7032	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	Asclemed USA, Inc.	9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0	2025-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	NCS HealthCare of KY, LLC dba Vangard Labs	d1e0c8fc-1f15-45a4-a80f-653a1dae5e56	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole DR	OMEPRAZOLE	Advanced Rx of Tennessee, LLC	af85afda-6b0c-d657-e053-2a95a90afb4b	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	30e58465-c5d2-4925-85bb-53faa6135c5c	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	Proficient Rx LP	5ad413ed-a21b-4f8b-9322-8fbb813b14d3	2024-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672

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
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	d9b3918c-a66e-4277-8b8f-b7ece93fa7db	21
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	d9b3918c-a66e-4277-8b8f-b7ece93fa7db	21
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	2b7491dd-19f5-42e0-b901-7ba71a3820c7	20
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	2b7491dd-19f5-42e0-b901-7ba71a3820c7	20
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	d1e0c8fc-1f15-45a4-a80f-653a1dae5e56	16
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	d1e0c8fc-1f15-45a4-a80f-653a1dae5e56	16
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	30e58465-c5d2-4925-85bb-53faa6135c5c	15
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	30e58465-c5d2-4925-85bb-53faa6135c5c	15
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	c6c22be1-659d-4e71-b292-701e27da201b	14
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	c6c22be1-659d-4e71-b292-701e27da201b	14
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	c6bc8fb7-2862-464a-b7c9-e409034f072a	14
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	c6c22be1-659d-4e71-b292-701e27da201b	14
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	c6bc8fb7-2862-464a-b7c9-e409034f072a	14
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	c6c22be1-659d-4e71-b292-701e27da201b	14
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	c6bc8fb7-2862-464a-b7c9-e409034f072a	14
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	c6c22be1-659d-4e71-b292-701e27da201b	14
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	c6c22be1-659d-4e71-b292-701e27da201b	14
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	c6bc8fb7-2862-464a-b7c9-e409034f072a	14
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	c6c22be1-659d-4e71-b292-701e27da201b	14
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	c6c22be1-659d-4e71-b292-701e27da201b	14
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	c6bc8fb7-2862-464a-b7c9-e409034f072a	14
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	fa0395a7-4353-4d64-9de8-d15857a7031c	8
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	c8bf92c9-1bab-7985-e053-2995a90a0225	8
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	c8bf92c9-1bab-7985-e053-2995a90a0225	8
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	fa0395a7-4353-4d64-9de8-d15857a7031c	8
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	5ad413ed-a21b-4f8b-9322-8fbb813b14d3	7
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	5ad413ed-a21b-4f8b-9322-8fbb813b14d3	7
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0	6
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0	6
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0	6
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	4be616c4-1b9a-5654-e054-00144ff88e88	6
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	1eb34cff-59c5-4411-b587-10207ffb58c4	6
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0	6
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0	6
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	1eb34cff-59c5-4411-b587-10207ffb58c4	6
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0	6
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	4be616c4-1b9a-5654-e054-00144ff88e88	6
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0	6
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0	6
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	80ef3211-8502-4e06-944f-6e406a9edfa0	3
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	80ef3211-8502-4e06-944f-6e406a9edfa0	3
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	bab55f83-ba03-49a0-842a-19c9976b7fe8	2
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	bab55f83-ba03-49a0-842a-19c9976b7fe8	2
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	9af00688-8cd1-35c5-e053-2995a90ab011	1
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	26b9016c-d651-688b-e063-6394a90a8fb2	1
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	4f5c91e6-6377-ca94-e063-6294a90a2f99	1
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	1e1a997a-9207-441c-e063-6294a90a503e	1
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	4f5c91e6-6377-ca94-e063-6294a90a2f99	1
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	26b9016c-d651-688b-e063-6394a90a8fb2	1
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	9af00688-8cd1-35c5-e053-2995a90ab011	1
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	1e1a997a-9207-441c-e063-6294a90a503e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-397-01	68462039701	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-397-01)	2016-10-01	0000-00-00	No	No	Current
68462-397-10	68462039710	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-397-10)	2016-10-01	0000-00-00	No	No	Current
68462-397-30	68462039730	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-397-30)	2016-10-01	0000-00-00	No	No	Current
68462-397-90	68462039790	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-397-90)	2016-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole	HAWAII REPACK, INC.	2026-07-13	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	REMEDYREPACK INC.	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	22
Omeprazole	ST. MARY'S MEDICAL PARK PHARMACY	2026-04-13	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole DR Capsules	Advanced Rx Pharmacy of Tennessee, LLC	2026-03-13	HUMAN PRESCRIPTION DRUG LABEL	8
Omeprazole	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-01-19	HUMAN PRESCRIPTION DRUG LABEL	14
Omeprazole	Preferred Pharmaceuticals Inc.	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	8
Omeprazole	Aphena Pharma Solutions - Tennessee, LLC	2025-08-28	HUMAN PRESCRIPTION DRUG LABEL	2
Omeprazole	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-02-13	HUMAN PRESCRIPTION DRUG LABEL	6
Omeprazole	NCS HealthCare of KY, LLC dba Vangard Labs	2025-01-16	HUMAN PRESCRIPTION DRUG LABEL	16
Omeprazole	Coupler LLC	2024-11-12	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	A-S Medication Solutions	2024-09-05	HUMAN PRESCRIPTION DRUG LABEL	15
Omeprazole	Proficient Rx LP	2024-09-01	HUMAN PRESCRIPTION DRUG LABEL	7
Omeprazole	A-S Medication Solutions	2024-08-30	HUMAN PRESCRIPTION DRUG LABEL	6
Omeprazole	Bryant Ranch Prepack	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	20
Omeprazole	RedPharm Drug	2024-07-25	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	NuCarePharmaceuticals, Inc. \| NuCare Pharmaceuticals, Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	6
Omeprazole	RPK Pharmaceuticals, Inc.	2023-09-12	HUMAN PRESCRIPTION DRUG LABEL	3
OMEPRAZOLE DR	Direct Rx	2023-05-31	HUMAN PRESCRIPTION DRUG LABEL	14
Omeprazole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	4
Omeprazole	NuCare Pharmaceuticals,Inc.	2021-06-08	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	NuCare Pharmaceuticals,Inc.	2021-02-10	HUMAN PRESCRIPTION DRUG LABEL	3
Omeprazole	medsource pharmaceuticals	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	1