Prilosec

Product NDC: 70515-625
11-digit product format: 705150625
Labeler code: 70515
Product ID: 70515-625_296db0e8-af6e-4053-874d-2a7c8f7aba50
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omeprazole magnesium
Dosage form: GRANULE, DELAYED RELEASE
Route: ORAL
Labeler: Covis Pharma US, Inc
Application: NDA022056
Marketing category: NDA
Marketing start: 2017-08-25
Substance: OMEPRAZOLE MAGNESIUM
Active strength: 2.5 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 42.

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
N022056-001	PRILOSEC	OMEPRAZOLE MAGNESIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2008-03-20
N022056-002	PRILOSEC	OMEPRAZOLE MAGNESIUM	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD, RS	2008-03-20

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022056-001	PRILOSEC	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD	2008-03-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022056-002	PRILOSEC	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	RLD, RS	2008-03-20	`bb7c543d1eb4…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022056-001	6428810	2019-11-03	U-1817	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022056-001	6428810	2019-11-03	U-864	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022056-002	6428810	2019-11-03	U-864	Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022056-001	6428810	2019-11-03	U-1817	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022056-001	6428810	2019-11-03	U-864	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022056-002	6428810	2019-11-03	U-864	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022056-001	6428810	2019-11-03	U-1817	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022056-001	6428810	2019-11-03	U-864	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022056-002	6428810	2019-11-03	U-864	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022056-001	6428810	2019-11-03	U-1817	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022056-001	6428810	2019-11-03	U-864	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022056-002	6428810	2019-11-03	U-864	Drug product	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Prilosec
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE MAGNESIUM	2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
426QFE7XLK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
797058	Internal RxNorm lookup
797061	Internal RxNorm lookup
797063	Internal RxNorm lookup
797065	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
b6761f84-53ac-4745-a8c8-1e5427d7e179	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70515-625-01	Prilosec	30 in 1 CARTON	GRANULE, DELAYED RELEASE	30		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70515-625-01	EA - Each	70515-625	2b2fbc97-313d-4201-8a77-ea72e675b1e2	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70515-625	PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [COVIS PHARMA US, INC]	8	Current NDC, Legacy NDC, 1 package rows	20240319_b6761f84-53ac-4745-a8c8-1e5427d7e179.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prilosec	OMEPRAZOLE MAGNESIUM	Covis Pharma US, Inc	b6761f84-53ac-4745-a8c8-1e5427d7e179	2024-03-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022056 application number: NDA022056 ndc (product): 70515-625

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
426QFE7XLK	OMEPRAZOLE MAGNESIUM	95382-33-5	OMEPRAZOLE MAGNESIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
797058	omeprazole 10 MG Delayed Release Granules for Oral Suspension	PSN	b6761f84-53ac-4745-a8c8-1e5427d7e179	8
797063	omeprazole 2.5 MG Delayed Release Granules for Oral Suspension	PSN	b6761f84-53ac-4745-a8c8-1e5427d7e179	8
797061	PriLOSEC 10 MG Delayed Release Granules for Oral Suspension	PSN	b6761f84-53ac-4745-a8c8-1e5427d7e179	8
797065	PriLOSEC 2.5 MG Delayed Release Granules for Oral Suspension	PSN	b6761f84-53ac-4745-a8c8-1e5427d7e179	8
797061	omeprazole 10 MG Granules for Oral Suspension [Prilosec]	SBD	b6761f84-53ac-4745-a8c8-1e5427d7e179	8
797065	omeprazole 2.5 MG Granules for Oral Suspension [Prilosec]	SBD	b6761f84-53ac-4745-a8c8-1e5427d7e179	8
797058	omeprazole 10 MG Granules for Oral Suspension	SCD	b6761f84-53ac-4745-a8c8-1e5427d7e179	8
797063	omeprazole 2.5 MG Granules for Oral Suspension	SCD	b6761f84-53ac-4745-a8c8-1e5427d7e179	8
797058	omeprazole 10 MG (as omeprazole magnesium 11.2 MG) Delayed Release Granules for Oral Suspension	SY	b6761f84-53ac-4745-a8c8-1e5427d7e179	8
797058	omeprazole 10 MG Delayed Release Granules for Oral Suspension	SY	b6761f84-53ac-4745-a8c8-1e5427d7e179	8
797063	omeprazole 2.5 MG (as omeprazole magnesium 2.8 MG) Delayed Release Granules for Oral Suspension	SY	b6761f84-53ac-4745-a8c8-1e5427d7e179	8
797063	omeprazole 2.5 MG Delayed Release Granules for Oral Suspension	SY	b6761f84-53ac-4745-a8c8-1e5427d7e179	8
797061	Prilosec 10 MG (omeprazole magnesium 11.2 MG) Delayed Release Granules for Oral Suspension	SY	b6761f84-53ac-4745-a8c8-1e5427d7e179	8
797061	Prilosec 10 MG Delayed Release Granules for Oral Suspension	SY	b6761f84-53ac-4745-a8c8-1e5427d7e179	8
797065	Prilosec 2.5 MG (omeprazole magnesium 2.8 MG) Delayed Release Granules for Oral Suspension	SY	b6761f84-53ac-4745-a8c8-1e5427d7e179	8
797065	Prilosec 2.5 MG Delayed Release Granules for Oral Suspension	SY	b6761f84-53ac-4745-a8c8-1e5427d7e179	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70515-625-01	70515062501	30 GRANULE, DELAYED RELEASE in 1 CARTON (70515-625-01)	2017-08-25	0000-00-00	No	No	Current