Omeprazole

Product NDC: 66336-706
11-digit product format: 663360706
Labeler code: 66336
Product ID: 66336-706_64218455-e1e2-4e40-bd32-5002d2d1555d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: ANDA075876
Marketing category: ANDA
Marketing start: 2012-12-12
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	66336-706		I	Inactivated by FDA		2026-08-03
excluded package	package	66336-706	66336-706-30	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 8 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	66336-706		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	66336-706	66336-706-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	66336-706		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	66336-706	66336-706-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	66336-706		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	66336-706	66336-706-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	66336-706		I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	66336-706	66336-706-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 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 · 3 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 · 3 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…`

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
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
66336-706-30	2019-11-27	C162847	48780-1	9855d018-e47d-cd31-e053-dbdaa90ab51a	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
66336-706-30	Omeprazole	30 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66336-706-30	EA - Each	66336-706	6ab00a2c-34e3-4781-8e1b-d69099bfdc61	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66336-706	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]	1	Legacy NDC, 1 package rows	20130704_8e3b29b0-d3a8-409a-b397-53dbbbcda094.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	8e3b29b0-d3a8-409a-b397-53dbbbcda094	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	8e3b29b0-d3a8-409a-b397-53dbbbcda094	1
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	8e3b29b0-d3a8-409a-b397-53dbbbcda094	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
66336-706-30	66336070630	30 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-07-03	HUMAN PRESCRIPTION DRUG LABEL	1