Omeprazole

Product NDC: 21695-098
11-digit product format: 216950098
Labeler code: 21695
Product ID: 21695-098_b6939539-2d45-4ea0-9744-72d7691e331f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: ANDA075410
Marketing category: ANDA
Marketing start: 2002-11-04
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: 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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-098		I	Inactivated by FDA	2026-07-31
excluded package	package	21695-098	21695-098-07	I	Inactivated by FDA	2026-07-31
excluded package	package	21695-098	21695-098-10	I	Inactivated by FDA	2026-07-31
excluded package	package	21695-098	21695-098-14	I	Inactivated by FDA	2026-07-31
excluded package	package	21695-098	21695-098-15	I	Inactivated by FDA	2026-07-31
excluded package	package	21695-098	21695-098-30	I	Inactivated by FDA	2026-07-31
excluded package	package	21695-098	21695-098-60	I	Inactivated by FDA	2026-07-31
excluded package	package	21695-098	21695-098-72	I	Inactivated by FDA	2026-07-31
excluded package	package	21695-098	21695-098-90	I	Inactivated by FDA	2026-07-31

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	Approval date
A075410-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01
A075410-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01
A075410-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075410-001	AB
A075410-002	AB
A075410-003	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	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`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	A075410-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075410-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075410-003	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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Chartwell RX, LLC	10f5502a-2e63-4f2a-a3ba-ddc5bd403051	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	ed9895ae-3d18-434c-8b56-47bccdc8fe6d	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	ad675ef6-5377-b9f2-e053-2995a90a06e9	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	55a1fb3c-f040-2e39-e054-00144ff8d46c	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	8991d464-7abc-4350-e053-2995a90a4ea7	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	1318a1c1-222d-471a-92d6-3632c82fb999	2024-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	18f5a7cc-40d8-4aeb-a601-47bc9024f130	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Lannett Company, Inc.	92201fb1-4570-42db-8da3-3b8c0e291d32	2023-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Proficient Rx LP	9786b04f-f827-460b-91bc-c0ac967f95dd	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	4b188d97-f1b3-468d-9818-b8333bf24b5a	2020-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410

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
21695-098-07	2019-09-24	C162847	48780-1	934fe258-4a31-48b1-e053-8cdaa90a720a	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. Initial U.S. Approval: 2002
21695-098-10	2019-09-24	C162847	48780-1	934fe258-4a31-48b1-e053-8cdaa90a720a	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. Initial U.S. Approval: 2002
21695-098-14	2019-09-24	C162847	48780-1	934fe258-4a31-48b1-e053-8cdaa90a720a	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. Initial U.S. Approval: 2002
21695-098-15	2019-09-24	C162847	48780-1	934fe258-4a31-48b1-e053-8cdaa90a720a	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. Initial U.S. Approval: 2002
21695-098-30	2019-09-24	C162847	48780-1	934fe258-4a31-48b1-e053-8cdaa90a720a	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. Initial U.S. Approval: 2002
21695-098-60	2019-09-24	C162847	48780-1	934fe258-4a31-48b1-e053-8cdaa90a720a	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. Initial U.S. Approval: 2002
21695-098-72	2019-09-24	C162847	48780-1	934fe258-4a31-48b1-e053-8cdaa90a720a	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. Initial U.S. Approval: 2002
21695-098-90	2019-09-24	C162847	48780-1	934fe258-4a31-48b1-e053-8cdaa90a720a	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. Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-098-07	Omeprazole	07 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	07	1
21695-098-10	Omeprazole	10 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	10	1
21695-098-14	Omeprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	1
21695-098-15	Omeprazole	15 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	15	1
21695-098-30	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	1
21695-098-60	Omeprazole	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60	1
21695-098-72	Omeprazole	120 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	120	1
21695-098-90	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-098-07	EA - Each	21695-098	b4443265-fda8-4609-9ecf-d5dd7b4c4dae	1	2012-07-24
21695-098-10	EA - Each	21695-098	98aff234-e2f4-49a0-828d-ba4bb2ea4e56	1	2012-07-24
21695-098-14	EA - Each	21695-098	cab110d6-a511-4903-979b-e043b5ef8664	1	2012-07-24
21695-098-15	EA - Each	21695-098	825a8c41-5c45-4da8-9997-a5913a070a4c	1	2012-07-24
21695-098-30	EA - Each	21695-098	83a465e0-efec-4bca-90c3-33c79e42ea4e	1	2012-07-24
21695-098-60	EA - Each	21695-098	3e1c272d-6c11-49ee-973a-d08f110dddef	1	2012-07-24
21695-098-72	EA - Each	21695-098	ad972fe0-d718-4562-80d3-36e1b52a5166	1	2012-07-24
21695-098-90	EA - Each	21695-098	f4d3a1d7-3be0-4535-91d1-856baff75d45	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 [REBEL DISTRIBUTORS CORP.]	1
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
GLYCERYL BEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-098	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 8 package rows	20100202_d58c0b66-475f-46b3-949d-cda5343e7239.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	d58c0b66-475f-46b3-949d-cda5343e7239	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	d58c0b66-475f-46b3-949d-cda5343e7239	1
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	d58c0b66-475f-46b3-949d-cda5343e7239	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	d58c0b66-475f-46b3-949d-cda5343e7239	1
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	d58c0b66-475f-46b3-949d-cda5343e7239	1
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	d58c0b66-475f-46b3-949d-cda5343e7239	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-098-07	21695009807	07 in 1 BOTTLE	Historical
21695-098-10	21695009810	10 in 1 BOTTLE	Historical
21695-098-14	21695009814	14 in 1 BOTTLE	Historical
21695-098-15	21695009815	15 in 1 BOTTLE	Historical
21695-098-30	21695009830	30 in 1 BOTTLE	Historical
21695-098-60	21695009860	60 in 1 BOTTLE	Historical
21695-098-72	21695009872	120 in 1 BOTTLE	Historical
21695-098-90	21695009890	90 in 1 BOTTLE	Historical