PRILOSEC

Product NDC: 0186-0610
11-digit product format: 001860610
Labeler code: 0186
Product ID: 0186-0610_3209e9cd-92a0-4e3d-8d26-cfb636faff9c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole magnesium
Dosage form: GRANULE, DELAYED RELEASE
Route: ORAL
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA022056
Marketing category: NDA
Marketing start: 2002-02-09
Marketing end: 2020-06-01
Substance: OMEPRAZOLE MAGNESIUM
Active strength: 10 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	0186-0610		D	Discontinued by firm		2026-08-17
excluded package	package	0186-0610	0186-0610-01	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0186-0610-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0186-0610-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0186-0610-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0186-0610-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0186-0610-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0186-0610-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0186-0610-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0186-0610-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0186-0610-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0186-0610-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0186-0610-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0186-0610-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0186-0610-01	EA - Each	0186-0610	94e26fed-f012-4292-a42b-a7fff07e2243	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMEPRAZOLE MAGNESIUM	ACTIVE INGREDIENT	426QFE7XLK	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
ANHYDROUS DEXTROSE	INACTIVE INGREDIENT	5SL0G7R0OK	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
D&C RED NO. 7	INACTIVE INGREDIENT	ECW0LZ41X8	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	PRILOSEC (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE PRILOSEC (OMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA LP]	29

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

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRILOSEC	AstraZeneca Pharmaceuticals LP \| AstraZeneca PLC	2016-12-22	HUMAN PRESCRIPTION DRUG LABEL	37