Prilosec OTC

Product NDC: 70518-2167
Requested package NDC: 70518-2167-0
11-digit product format: 705182167
Labeler code: 70518
Product ID: 70518-2167_dae52391-e956-e31a-e053-2995a90acb7e
Type: HUMAN OTC DRUG
Nonproprietary name: omeprazole magnesium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA021229
Marketing category: NDA
Marketing start: 2019-06-28
Marketing end: 0000-00-00
Substance: OMEPRAZOLE MAGNESIUM
Active strength: 21 mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-2167	70518-2167-0	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021229-001	PRILOSEC OTC	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2003-06-20

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021229-001	PRILOSEC OTC	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2003-06-20	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021229-001	6428810	2019-11-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021229-001	6403616	2019-11-15	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021229-001	6428810	2019-11-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021229-001	6403616	2019-11-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021229-001	6428810	2019-11-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021229-001	6403616	2019-11-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021229-001	6428810	2019-11-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021229-001	6403616	2019-11-15	`ea99ee380514…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prilosec OTC	OMEPRAZOLE MAGNESIUM	The Procter & Gamble Manufacturing Company	77ed80a2-a482-4838-ac55-4865b5c31d9f	2025-10-01	Warnings	Exact identifier application applno (NDA): 021229 application number: NDA021229
Prilosec OTC	OMEPRAZOLE MAGNESIUM	The Procter & Gamble Manufacturing Company	35a79458-79f6-44d6-b74c-b4f4aaf0dde0	2025-10-01	Warnings	Exact identifier application applno (NDA): 021229 application number: NDA021229

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2167-0	70518216700	30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-2167-0)	2019-06-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prilosec OTC ® omeprazole magnesium delayed- release tablets 20.6 mg / acid reducer	REMEDYREPACK INC.	2022-03-23	HUMAN OTC DRUG LABEL	4