Omeprazole

Product NDC: 0781-2790
11-digit product format: 007812790
Labeler code: 0781
Product ID: 0781-2790_24a57c2e-eda8-4c3f-9c81-a28a5b9a9229
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA075757
Marketing category: ANDA
Marketing start: 2003-01-28
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075757-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28
A075757-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075757-001	AB
A075757-002	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	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`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	A075757-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075757-002	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 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	St. Mary's Medical Park Pharmacy	db9f071b-85f4-061f-e053-2995a90a3ff5	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	QPharma Inc	f6f6ad19-ff6a-7cd3-e053-6294a90ae1bf	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	f76c23d5-26b6-cfb2-e053-6294a90aea42	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	0fb314cb-6291-422c-98ff-24d8449992f6	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Chartwell RX, LLC	4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e	2025-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Sandoz Inc	516170d4-4913-4577-a2d2-f5c52d1e79c6	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Proficient Rx LP	ee0598a1-0e5e-40ff-ad88-b0adfc533ca0	2024-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	17664f71-154a-47c6-b83c-b349bbc8a98f	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Sandoz Inc	e4562da8-9d94-4417-9f80-c1ffd4247259	2023-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757 ndc (product): 0781-2790

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198051	Internal RxNorm lookup
199119	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
e4562da8-9d94-4417-9f80-c1ffd4247259	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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
0781-2790-01	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	11
0781-2790-10	Omeprazole	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	11
0781-2790-31	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	11
0781-2790-92	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-2790-01	EA - Each	0781-2790	507bc27a-c9b4-431c-a98b-121363062e8f	1	2015-10-02
0781-2790-10	EA - Each	0781-2790	f28e8f36-cef4-4ad8-9f70-ff996fe0adaa	1	2015-08-04
0781-2790-31	EA - Each	0781-2790	0eda754b-f223-4085-a4b6-478ab5506d86	1	2015-08-04
0781-2790-92	EA - Each	0781-2790	33feae09-cc1d-4b0c-a926-e16f09400fbc	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-2790	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	11	Current NDC, Legacy NDC, 4 package rows	20231020_e4562da8-9d94-4417-9f80-c1ffd4247259.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
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	e4562da8-9d94-4417-9f80-c1ffd4247259	11
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	e4562da8-9d94-4417-9f80-c1ffd4247259	11
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	e4562da8-9d94-4417-9f80-c1ffd4247259	11
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	e4562da8-9d94-4417-9f80-c1ffd4247259	11
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	e4562da8-9d94-4417-9f80-c1ffd4247259	11
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	e4562da8-9d94-4417-9f80-c1ffd4247259	11
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	74f888ce-5f95-cad0-e053-2991aa0a2d79	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	74f888ce-5f95-cad0-e053-2991aa0a2d79	1
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	74f888ce-5f95-cad0-e053-2991aa0a2d79	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-2790-01	00781279001	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2790-01)	2003-01-28	0000-00-00	No	No	Current
0781-2790-10	00781279010	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2790-10)	2003-01-28	0000-00-00	No	No	Current
0781-2790-31	00781279031	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2790-31)	2003-01-28	0000-00-00	No	No	Current
0781-2790-92	00781279092	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2790-92)	2003-01-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole	Sandoz Inc	2023-04-30	HUMAN PRESCRIPTION DRUG LABEL	11
Omeprazole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-12-30	HUMAN PRESCRIPTION DRUG LABEL	3
Omeprazole	NCS HealthCare of KY, Inc dba Vangard Labs	2019-08-12	HUMAN PRESCRIPTION DRUG LABEL	3
Omeprazole	REMEDYREPACK INC.	2019-08-12	HUMAN PRESCRIPTION DRUG LABEL	3
Omeprazole	REMEDYREPACK INC.	2019-08-01	HUMAN PRESCRIPTION DRUG LABEL	3
Omeprazole	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2018-09-03	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	A-S Medication Solutions	2018-08-29	HUMAN PRESCRIPTION DRUG LABEL	8