YOSPRALA

Product NDC: 70347-325
11-digit product format: 703470325
Labeler code: 70347
Product ID: 70347-325_eb6e5371-d9fb-4b94-9e1e-224d8cf9f7e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aspirin and Omeprazole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aralez Pharmaceuticals Us Inc.
Application: NDA205103
Marketing category: NDA
Marketing start: 2016-09-14
Marketing end: 0000-00-00
Substance: ASPIRIN; OMEPRAZOLE
Active strength: 325 mg/1; mg/1
Pharmacologic classes: Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70347-325		I	Inactivated by FDA	2026-08-17
excluded package	package	70347-325	70347-325-30	I	Inactivated by FDA	2026-08-17
excluded package	package	70347-325	70347-325-90	I	Inactivated by FDA	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 2 · 63 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	70347-325-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70347-325-90	`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	70347-325-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70347-325-90	`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	70347-325-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70347-325-90	`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	70347-325-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70347-325-90	`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	70347-325-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70347-325-90	`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	70347-325-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70347-325-90	`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	70347-325-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70347-325-90	`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	70347-325-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70347-325-90	`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	70347-325-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70347-325-90	`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	70347-325-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70347-325-90	`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	70347-325-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70347-325-90	`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	70347-325-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70347-325-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70347-325-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70347-325-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70347-325-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70347-325-90	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70347-325-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70347-325-90	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70347-325-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70347-325-90	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70347-325-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70347-325-90	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70347-325-30	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70347-325-90	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	70347-325-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	70347-325-90	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	70347-325-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	70347-325-90	`e2bbac7714bc…`	`27bdfed8d636…`

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
N205103-001	YOSPRALA	ASPIRIN; OMEPRAZOLE	81MG;40MG	TABLET, DELAYED RELEASE / ORAL		RLD	2016-09-14
N205103-002	YOSPRALA	ASPIRIN; OMEPRAZOLE	325MG;40MG	TABLET, DELAYED RELEASE / ORAL		RLD	2016-09-14

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N205103-001	9987231	2033-01-02	U-2324	2018-07-03
N205103-001	9539214	2033-03-13	U-1902	2017-01-27
N205103-002	9987231	2033-01-02	U-2324	2018-07-03
N205103-002	9539214	2033-03-13	U-1902	2017-01-27

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	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2016-09-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205103-001	YOSPRALA	81MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205103-002	YOSPRALA	325MG;40MG	TABLET, DELAYED RELEASE / ORAL	RLD	2016-09-14	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 300 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N205103-001	9987231	2033-01-02	U-2324	2018-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205103-001	9539214	2033-03-13	U-1902	2017-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205103-002	9987231	2033-01-02	U-2324	2018-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205103-002	9539214	2033-03-13	U-1902	2017-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205103-001	9987231	2033-01-02	U-2324	2018-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205103-001	9539214	2033-03-13	U-1902	2017-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205103-002	9987231	2033-01-02	U-2324	2018-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205103-002	9539214	2033-03-13	U-1902	2017-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205103-001	9987231	2033-01-02	U-2324	2018-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205103-001	9539214	2033-03-13	U-1902	2017-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205103-002	9987231	2033-01-02	U-2324	2018-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205103-002	9539214	2033-03-13	U-1902	2017-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205103-001	9987231	2033-01-02	U-2324	2018-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205103-001	9539214	2033-03-13	U-1902	2017-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205103-002	9987231	2033-01-02	U-2324	2018-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205103-002	9539214	2033-03-13	U-1902	2017-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205103-001	9987231	2033-01-02	U-2324	2018-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205103-001	9539214	2033-03-13	U-1902	2017-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205103-002	9987231	2033-01-02	U-2324	2018-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205103-002	9539214	2033-03-13	U-1902	2017-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205103-001	9987231	2033-01-02	U-2324	2018-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205103-001	9539214	2033-03-13	U-1902	2017-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205103-002	9987231	2033-01-02	U-2324	2018-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205103-002	9539214	2033-03-13	U-1902	2017-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205103-001	9987231	2033-01-02	U-2324	2018-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205103-001	9539214	2033-03-13	U-1902	2017-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205103-002	9987231	2033-01-02	U-2324	2018-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205103-002	9539214	2033-03-13	U-1902	2017-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205103-001	9987231	2033-01-02	U-2324	2018-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205103-001	9539214	2033-03-13	U-1902	2017-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205103-002	9987231	2033-01-02	U-2324	2018-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205103-002	9539214	2033-03-13	U-1902	2017-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205103-001	9987231	2033-01-02	U-2324	2018-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205103-001	9539214	2033-03-13	U-1902	2017-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205103-002	9987231	2033-01-02	U-2324	2018-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205103-002	9539214	2033-03-13	U-1902	2017-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205103-001	9987231	2033-01-02	U-2324	2018-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205103-001	9539214	2033-03-13	U-1902	2017-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205103-002	9987231	2033-01-02	U-2324	2018-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205103-002	9539214	2033-03-13	U-1902	2017-01-27	`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205103-001	NC	2019-09-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205103-002	NC	2019-09-14	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N205103-001	NC	2019-09-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205103-002	NC	2019-09-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205103-001	NC	2019-09-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205103-002	NC	2019-09-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205103-001	NC	2019-09-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205103-002	NC	2019-09-14	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70347-325-30	2020-01-31	C162847	48780-1	9d75b9cf-cf7a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use YOSPRALA safely and effectively. See full prescribing information for YOSPRALA . YOSPRALA (aspirin and omeprazole) delayed-release tablets, for oral use Initial U.S. Approval: 2016
70347-325-90	2020-01-31	C162847	48780-1	9d75b9cf-cf7a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use YOSPRALA safely and effectively. See full prescribing information for YOSPRALA . YOSPRALA (aspirin and omeprazole) delayed-release tablets, for oral use Initial U.S. Approval: 2016

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70347-325-30	YOSPRALA	30 in 1 BOTTLE	TABLET, FILM COATED	30		4
70347-325-90	YOSPRALA	90 in 1 BOTTLE	TABLET, FILM COATED	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70347-325-30	EA - Each	70347-325	9178fcb0-9ff3-4098-b39a-f429eb279a4c	1	2016-10-06
70347-325-90	EA - Each	70347-325	56ec6b43-93a6-4cea-9fa5-b7e8b33ea705	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70347-325	YOSPRALA (ASPIRIN AND OMEPRAZOLE) TABLET, FILM COATED [ARALEZ PHARMACEUTICALS US INC.]	4	Legacy NDC, 2 package rows	20180622_73f74f6d-e624-4551-8924-1c747ffb2140.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN
KG60484QX9	OMEPRAZOLE	73590-58-6	OMEPRAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1811632	aspirin 325 MG / omeprazole 40 MG Delayed Release Oral Tablet	PSN	73f74f6d-e624-4551-8924-1c747ffb2140	4
1811631	aspirin 81 MG / omeprazole 40 MG Delayed Release Oral Tablet	PSN	73f74f6d-e624-4551-8924-1c747ffb2140	4
1811916	Yosprala 325 MG / 40 MG Delayed Release Oral Tablet	PSN	73f74f6d-e624-4551-8924-1c747ffb2140	4
1811918	Yosprala 81 MG / 40 MG Delayed Release Oral Tablet	PSN	73f74f6d-e624-4551-8924-1c747ffb2140	4
1811916	aspirin 325 MG / omeprazole 40 MG Delayed Release Oral Tablet [Yosprala]	SBD	73f74f6d-e624-4551-8924-1c747ffb2140	4
1811918	aspirin 81 MG / omeprazole 40 MG Delayed Release Oral Tablet [Yosprala]	SBD	73f74f6d-e624-4551-8924-1c747ffb2140	4
1811632	aspirin 325 MG / omeprazole 40 MG Delayed Release Oral Tablet	SCD	73f74f6d-e624-4551-8924-1c747ffb2140	4
1811631	aspirin 81 MG / omeprazole 40 MG Delayed Release Oral Tablet	SCD	73f74f6d-e624-4551-8924-1c747ffb2140	4
1811632	ASA 325 MG / Omeprazole 40 MG Delayed Release Oral Tablet	SY	73f74f6d-e624-4551-8924-1c747ffb2140	4
1811916	ASA 325 MG / Omeprazole 40 MG Delayed Release Oral Tablet [Yosprala]	SY	73f74f6d-e624-4551-8924-1c747ffb2140	4
1811631	ASA 81 MG / Omeprazole 40 MG Delayed Release Oral Tablet	SY	73f74f6d-e624-4551-8924-1c747ffb2140	4
1811918	ASA 81 MG / Omeprazole 40 MG Delayed Release Oral Tablet [Yosprala]	SY	73f74f6d-e624-4551-8924-1c747ffb2140	4
1811916	Yosprala (aspirin 325 MG (delayed-release) / omeprazole 40 MG (immediate-release)) Delayed Release Oral Tablet	SY	73f74f6d-e624-4551-8924-1c747ffb2140	4
1811918	Yosprala (aspirin 81 MG (delayed-release) / omeprazole 40 MG (immediate-release)) Delayed Release Oral Tablet	SY	73f74f6d-e624-4551-8924-1c747ffb2140	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
70347-325-30	70347032530	30 in 1 BOTTLE	Historical
70347-325-90	70347032590	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
YOSPRALA	Aralez Pharmaceuticals Us Inc. \| ARALEZ PHARMACEUTICALS TRADING DESIGNATED ACTIVITY COMPANY \| Patheon Pharmaceuticals Inc.	2018-06-19	HUMAN PRESCRIPTION DRUG LABEL	4