Omeprazole

Product NDC: 63629-2607
11-digit product format: 636292607
Labeler code: 63629
Product ID: 63629-2607_0a276c6b-0285-4e4d-9f2c-3cb73cabed77
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075876
Marketing category: ANDA
Marketing start: 2003-08-04
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: No
Listing certified through: 2021-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-2607		D	Discontinued by firm	2026-08-03
excluded package	package	63629-2607	63629-2607-0	D	Discontinued by firm	2026-08-03
excluded package	package	63629-2607	63629-2607-1	D	Discontinued by firm	2026-08-03
excluded package	package	63629-2607	63629-2607-2	D	Discontinued by firm	2026-08-03
excluded package	package	63629-2607	63629-2607-3	D	Discontinued by firm	2026-08-03
excluded package	package	63629-2607	63629-2607-4	D	Discontinued by firm	2026-08-03
excluded package	package	63629-2607	63629-2607-5	D	Discontinued by firm	2026-08-03
excluded package	package	63629-2607	63629-2607-6	D	Discontinued by firm	2026-08-03
excluded package	package	63629-2607	63629-2607-7	D	Discontinued by firm	2026-08-03
excluded package	package	63629-2607	63629-2607-8	D	Discontinued by firm	2026-08-03
excluded package	package	63629-2607	63629-2607-9	D	Discontinued by firm	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A075876-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075876-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	2003-05-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075876-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	2009-01-21	`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-2607-0	2020-10-16	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-1	2020-10-16	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-2	2020-10-16	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-3	2020-10-16	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-4	2020-10-16	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-5	2020-10-16	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-6	2020-10-16	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-7	2020-10-16	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-8	2020-10-16	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-9	2020-10-16	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-0	2020-01-31	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-1	2020-01-31	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-2	2020-01-31	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-3	2020-01-31	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-4	2020-01-31	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-5	2020-01-31	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-6	2020-01-31	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-7	2020-01-31	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-8	2020-01-31	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989
63629-2607-9	2020-01-31	C162847	48780-1	9d75b9d0-5f8c-f424-e053-dadaa90a57ce	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, for oral use Initial U.S. Approval: 1989

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2607-0	EA - Each	63629-2607	fd1035d1-34b4-47a2-ad30-6dd4e4d463cd	1	2014-09-03
63629-2607-1	EA - Each	63629-2607	b64e5625-4aa1-48a8-9219-e45642757f9b	1	2012-07-24
63629-2607-2	EA - Each	63629-2607	8c7a58c1-09cf-4498-996a-74629ae00f98	1	2012-07-24
63629-2607-3	EA - Each	63629-2607	e9ff3355-5409-4b9a-ab51-47d776272be1	1	2012-07-24
63629-2607-4	EA - Each	63629-2607	ef8b8e52-16bf-41da-9543-4bff66143712	1	2012-07-24
63629-2607-5	EA - Each	63629-2607	e44e185f-97cd-42a5-95f1-1b3674e3f8a9	1	2012-07-24
63629-2607-6	EA - Each	63629-2607	a58ec682-db64-4078-8d95-8f3963eb41f5	1	2012-07-24
63629-2607-7	EA - Each	63629-2607	f01ac394-a883-4863-b5b3-62e0fd264d0e	1	2012-07-24
63629-2607-8	EA - Each	63629-2607	69cbc6c0-ea16-49b7-aedd-b36e08374ee9	1	2012-07-24
63629-2607-9	EA - Each	63629-2607	3df32df8-3035-43ac-b17f-17ac84510fa3	1	2012-07-24

DailyMed Socrata Ingredients#

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KG60484QX9	OMEPRAZOLE	73590-58-6	OMEPRAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2607-0	63629260700	7 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-2607-0)	2005-04-22	0000-00-00	No	No	Current
63629-2607-1	63629260701	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-2607-1)	2007-05-29	0000-00-00	No	No	Current
63629-2607-2	63629260702	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-2607-2)	2007-05-29	0000-00-00	No	No	Current
63629-2607-3	63629260703	56 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-2607-3)	2007-05-29	0000-00-00	No	No	Current
63629-2607-4	63629260704	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-2607-4)	2007-05-29	0000-00-00	No	No	Current
63629-2607-5	63629260705	20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-2607-5)	2007-05-29	0000-00-00	No	No	Current
63629-2607-6	63629260706	15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-2607-6)	2007-05-29	0000-00-00	No	No	Current
63629-2607-7	63629260707	120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-2607-7)	2007-05-29	0000-00-00	No	No	Current
63629-2607-8	63629260708	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-2607-8)	2007-05-29	0000-00-00	No	No	Current
63629-2607-9	63629260709	28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-2607-9)	2007-05-29	0000-00-00	No	No	Current