Omeprazole

Product NDC: 68788-6881
11-digit product format: 687886881
Labeler code: 68788
Product ID: 68788-6881_2ab7deaf-58ca-47ce-97ea-17adaf9d5d15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA091672
Marketing category: ANDA
Marketing start: 2017-01-20
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 1.

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.

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
2026-08-01 22:54:32	2026-06	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2014-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2014-10-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A091672-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091672-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091672-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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 ndc (product): 68788-6881
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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198051	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
aa8fc2ea-3942-453b-bc19-1e4b14ba6926	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
68788-6881-1	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	10
68788-6881-2	Omeprazole	20 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	20	10
68788-6881-3	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	10
68788-6881-4	Omeprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	10
68788-6881-6	Omeprazole	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60	10
68788-6881-8	Omeprazole	120 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	120	10
68788-6881-9	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-6881-3	EA - Each	68788-6881	c39d754f-7bf4-4570-b578-cc21fc0a87f9	1	2019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-6881	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]	8	Current NDC, Legacy NDC, 7 package rows	20240726_aa8fc2ea-3942-453b-bc19-1e4b14ba6926.zip

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	aa8fc2ea-3942-453b-bc19-1e4b14ba6926	10
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	aa8fc2ea-3942-453b-bc19-1e4b14ba6926	10
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	aa8fc2ea-3942-453b-bc19-1e4b14ba6926	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-6881-1	68788688101	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6881-1)	2017-01-20	0000-00-00	No	No	Current
68788-6881-2	68788688102	20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6881-2)	2017-01-20	0000-00-00	No	No	Current
68788-6881-3	68788688103	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6881-3)	2017-01-20	0000-00-00	No	No	Current
68788-6881-4	68788688104	14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6881-4)	2017-01-20	0000-00-00	No	No	Current
68788-6881-6	68788688106	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6881-6)	2017-01-20	0000-00-00	No	No	Current
68788-6881-8	68788688108	120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6881-8)	2017-01-20	0000-00-00	No	No	Current
68788-6881-9	68788688109	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6881-9)	2017-01-20	0000-00-00	No	No	Current