Omeprazole

Product NDC: 53808-0746
11-digit product format: 538080746
Labeler code: 53808
Product ID: 53808-0746_596008d9-a14e-42a8-b2f4-799480123e7b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA075876
Marketing category: ANDA
Marketing start: 2009-07-01
Marketing end: 0000-00-00
Substance: OMEPRAZOLE
Active strength: 20 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-0746		I	Inactivated by FDA		2026-08-03
excluded package	package	53808-0746	53808-0746-1	I	Inactivated by FDA		2026-08-03

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	Approval date
A075876-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29
A075876-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29
A075876-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21

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 3 · 99 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
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2003-05-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL		2009-01-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL		2003-05-29	`5aa47cf7b7d7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075876-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075876-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075876-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075876-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075876-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075876-003	AB	1	`ea99ee380514…`

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0746-1	2019-10-21	C162847	48780-1	956f9ecf-d152-621f-e053-dbdaa90a74ad	These highlights do not include all the information needed to use omeprazole delayed-release capsules safely and effectively. See full prescribing information for omeprazole delayed-release capsules. Omeprazole Delayed-Release Capsules, USP Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0746-1	Omeprazole	30 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ETHYLCELLULOSE	INACTIVE INGREDIENT	7Z8S9VYZ4B	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0746	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20100611_1577bc9c-24d3-450e-b438-d4f1b5db6485.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	1577bc9c-24d3-450e-b438-d4f1b5db6485	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	1577bc9c-24d3-450e-b438-d4f1b5db6485	1
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	1577bc9c-24d3-450e-b438-d4f1b5db6485	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0746-1	53808074601	30 in 1 BLISTER PACK	Historical