ZYPITAMAG

Product NDC: 25208-202
11-digit product format: 252080202
Labeler code: 25208
Product ID: 25208-202_d39ef44a-4e4d-459d-86bd-79394202e3ec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pitavastatin Magnesium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Medicure International Inc
Application: NDA208379
Marketing category: NDA
Marketing start: 2018-03-09
Substance: PITAVASTATIN
Active strength: 4 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	25208-202	25208-202-10	D	Discontinued by firm	2026-09-14
excluded package	package	25208-202	25208-202-11	D	Discontinued by firm	2026-09-14
excluded package	package	25208-202	25208-202-12	D	Discontinued by firm	2026-09-14
excluded package	package	25208-202	25208-202-13	D	Discontinued by firm	2026-09-14
excluded package	package	25208-202	25208-202-14	D	Discontinued by firm	2026-09-14

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 · 45 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	25208-202-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	25208-202-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	25208-202-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	25208-202-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	25208-202-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	25208-202-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	25208-202-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	25208-202-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	25208-202-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	25208-202-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	25208-202-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	25208-202-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	25208-202-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	25208-202-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	25208-202-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	25208-202-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	25208-202-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	25208-202-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	25208-202-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	25208-202-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	25208-202-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	25208-202-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	25208-202-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	25208-202-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	25208-202-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	25208-202-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	25208-202-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	25208-202-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	25208-202-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	25208-202-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	25208-202-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	25208-202-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	25208-202-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	25208-202-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	25208-202-12	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	25208-202-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	25208-202-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	25208-202-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	25208-202-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	25208-202-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	25208-202-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	25208-202-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	25208-202-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	25208-202-13	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	25208-202-12	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date
N208379-001	ZYPITAMAG	PITAVASTATIN MAGNESIUM	EQ 1MG BASE	TABLET / ORAL	RLD	2017-07-14
N208379-002	ZYPITAMAG	PITAVASTATIN MAGNESIUM	EQ 2MG BASE	TABLET / ORAL	RLD	2017-07-14
N208379-003	ZYPITAMAG	PITAVASTATIN MAGNESIUM	EQ 4MG BASE	TABLET / ORAL	RLD, RS	2017-07-14

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N208379-001	8829186	2031-01-19	Drug substance, Drug product	2017-08-10
N208379-002	8829186	2031-01-19	Drug substance, Drug product	2017-08-10
N208379-003	8829186	2031-01-19	Drug substance, Drug product	2017-08-10

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208379-001	ZYPITAMAG	EQ 1MG BASE	TABLET / ORAL	RLD	2017-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208379-002	ZYPITAMAG	EQ 2MG BASE	TABLET / ORAL	RLD	2017-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208379-003	ZYPITAMAG	EQ 4MG BASE	TABLET / ORAL	RLD, RS	2017-07-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208379-001	ZYPITAMAG	EQ 1MG BASE	TABLET / ORAL	RLD	2017-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208379-002	ZYPITAMAG	EQ 2MG BASE	TABLET / ORAL	RLD	2017-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208379-003	ZYPITAMAG	EQ 4MG BASE	TABLET / ORAL	RLD, RS	2017-07-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208379-001	ZYPITAMAG	EQ 1MG BASE	TABLET / ORAL	RLD	2017-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208379-002	ZYPITAMAG	EQ 2MG BASE	TABLET / ORAL	RLD	2017-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208379-003	ZYPITAMAG	EQ 4MG BASE	TABLET / ORAL	RLD, RS	2017-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208379-001	ZYPITAMAG	EQ 1MG BASE	TABLET / ORAL	RLD	2017-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208379-002	ZYPITAMAG	EQ 2MG BASE	TABLET / ORAL	RLD	2017-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208379-003	ZYPITAMAG	EQ 4MG BASE	TABLET / ORAL	RLD, RS	2017-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208379-001	ZYPITAMAG	EQ 1MG BASE	TABLET / ORAL	RLD	2017-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208379-002	ZYPITAMAG	EQ 2MG BASE	TABLET / ORAL	RLD	2017-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208379-003	ZYPITAMAG	EQ 4MG BASE	TABLET / ORAL	RLD, RS	2017-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208379-001	ZYPITAMAG	EQ 1MG BASE	TABLET / ORAL	RLD	2017-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208379-002	ZYPITAMAG	EQ 2MG BASE	TABLET / ORAL	RLD	2017-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208379-003	ZYPITAMAG	EQ 4MG BASE	TABLET / ORAL	RLD, RS	2017-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208379-001	ZYPITAMAG	EQ 1MG BASE	TABLET / ORAL	RLD	2017-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208379-002	ZYPITAMAG	EQ 2MG BASE	TABLET / ORAL	RLD	2017-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208379-003	ZYPITAMAG	EQ 4MG BASE	TABLET / ORAL	RLD, RS	2017-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208379-001	ZYPITAMAG	EQ 1MG BASE	TABLET / ORAL	RLD	2017-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208379-002	ZYPITAMAG	EQ 2MG BASE	TABLET / ORAL	RLD	2017-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208379-003	ZYPITAMAG	EQ 4MG BASE	TABLET / ORAL	RLD, RS	2017-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208379-001	ZYPITAMAG	EQ 1MG BASE	TABLET / ORAL	RLD	2017-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208379-002	ZYPITAMAG	EQ 2MG BASE	TABLET / ORAL	RLD	2017-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208379-003	ZYPITAMAG	EQ 4MG BASE	TABLET / ORAL	RLD, RS	2017-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208379-001	ZYPITAMAG	EQ 1MG BASE	TABLET / ORAL	RLD	2017-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208379-002	ZYPITAMAG	EQ 2MG BASE	TABLET / ORAL	RLD	2017-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208379-003	ZYPITAMAG	EQ 4MG BASE	TABLET / ORAL	RLD, RS	2017-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208379-001	ZYPITAMAG	EQ 1MG BASE	TABLET / ORAL	RLD	2017-07-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208379-002	ZYPITAMAG	EQ 2MG BASE	TABLET / ORAL	RLD	2017-07-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208379-003	ZYPITAMAG	EQ 4MG BASE	TABLET / ORAL	RLD, RS	2017-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208379-001	ZYPITAMAG	EQ 1MG BASE	TABLET / ORAL	RLD	2017-07-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208379-002	ZYPITAMAG	EQ 2MG BASE	TABLET / ORAL	RLD	2017-07-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208379-003	ZYPITAMAG	EQ 4MG BASE	TABLET / ORAL	RLD, RS	2017-07-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208379-001	ZYPITAMAG	EQ 1MG BASE	TABLET / ORAL	RLD	2017-07-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208379-002	ZYPITAMAG	EQ 2MG BASE	TABLET / ORAL	RLD	2017-07-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208379-003	ZYPITAMAG	EQ 4MG BASE	TABLET / ORAL	RLD, RS	2017-07-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208379-001	ZYPITAMAG	EQ 1MG BASE	TABLET / ORAL	RLD	2017-07-14	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208379-001	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208379-002	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208379-003	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208379-001	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208379-002	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208379-003	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208379-001	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208379-002	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208379-003	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208379-001	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208379-002	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208379-003	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208379-001	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208379-002	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208379-003	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208379-001	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208379-002	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208379-003	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208379-001	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208379-002	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208379-003	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208379-001	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208379-002	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208379-003	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208379-001	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208379-002	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208379-003	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208379-001	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208379-002	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208379-003	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208379-001	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208379-002	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208379-003	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208379-001	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208379-002	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208379-003	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208379-001	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208379-002	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208379-003	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208379-001	8829186	2031-01-19	Drug substance, Drug product	2017-08-10	`301d65b070ca…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PITAVASTATIN	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
M5681Q5F9P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2001262	Internal RxNorm lookup
2001264	Internal RxNorm lookup
2001266	Internal RxNorm lookup
2001268	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
c8c50e03-5cb8-43f4-bdef-8edd12f1945f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a3b6a39e-87bf-f126-1bde-83d69cbf558b	Product name	3	20250219
de94155c-7345-40be-9a5b-89d04e1ac565	Product name	1	20190313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
25208-202-09	ZYPITAMAG	90 in 1 BOTTLE	TABLET, FILM COATED	90	14
25208-202-10	ZYPITAMAG	1 in 1 CARTON	TABLET, FILM COATED	1	14
25208-202-10	ZYPITAMAG	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	14
25208-202-11	ZYPITAMAG	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	14
25208-202-12	ZYPITAMAG	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	14
25208-202-12	ZYPITAMAG	10 in 1 CARTON	TABLET, FILM COATED	10	14
25208-202-13	ZYPITAMAG	30 in 1 BOTTLE	TABLET, FILM COATED	30	14
25208-202-14	ZYPITAMAG	100 in 1 BOTTLE	TABLET, FILM COATED	100	14
25208-202-15	ZYPITAMAG	500 in 1 BOTTLE	TABLET, FILM COATED	500	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25208-202-09	EA - Each	25208-202	28c0c29d-e97b-4a28-9132-52e7d618f1e7	1	2018-04-19
25208-202-15	EA - Each	25208-202	cae03242-4aef-43c6-a947-7a1ae15de1f7	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25208-202	ZYPITAMAG (PITAVASTATIN MAGNESIUM) TABLET, FILM COATED [MEDICURE INTERNATIONAL INC]	13	Current NDC, Legacy NDC, 9 package rows	20241226_c8c50e03-5cb8-43f4-bdef-8edd12f1945f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZYPITAMAG	PITAVASTATIN MAGNESIUM	Medicure International Inc	c8c50e03-5cb8-43f4-bdef-8edd12f1945f	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208379 application number: NDA208379 ndc (product): 25208-202
ZYPITAMAG	PITAVASTATIN MAGNESIUM	Zydus Lifesciences Limited	e9f0fe3a-0462-4c24-8f22-3c89afe8fcea	2024-08-14		Exact identifier application applno (NDA): 208379 application number: NDA208379

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M5681Q5F9P	PITAVASTATIN	147511-69-1	PITAVASTATIN
BDS8LUQ384	PITAVASTATIN MAGNESIUM	956116-90-8	Pitavastatin Magnesium

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2001262	pitavastatin magnesium 2 MG Oral Tablet	PSN	c8c50e03-5cb8-43f4-bdef-8edd12f1945f	14
2001266	pitavastatin magnesium 4 MG Oral Tablet	PSN	c8c50e03-5cb8-43f4-bdef-8edd12f1945f	14
2001264	Zypitamag 2 MG Oral Tablet	PSN	c8c50e03-5cb8-43f4-bdef-8edd12f1945f	14
2001268	Zypitamag 4 MG Oral Tablet	PSN	c8c50e03-5cb8-43f4-bdef-8edd12f1945f	14
2001264	pitavastatin magnesium 2 MG Oral Tablet [Zypitamag]	SBD	c8c50e03-5cb8-43f4-bdef-8edd12f1945f	14
2001268	pitavastatin magnesium 4 MG Oral Tablet [Zypitamag]	SBD	c8c50e03-5cb8-43f4-bdef-8edd12f1945f	14
2001262	pitavastatin magnesium 2 MG Oral Tablet	SCD	c8c50e03-5cb8-43f4-bdef-8edd12f1945f	14
2001266	pitavastatin magnesium 4 MG Oral Tablet	SCD	c8c50e03-5cb8-43f4-bdef-8edd12f1945f	14
2001262	pitavastatin 2 MG (as pitavastatin magnesium 2.053 MG) Oral Tablet	SY	c8c50e03-5cb8-43f4-bdef-8edd12f1945f	14
2001266	pitavastatin 4 MG (as pitavastatin magnesium 4.106 MG) Oral Tablet	SY	c8c50e03-5cb8-43f4-bdef-8edd12f1945f	14
2001264	Zypitamag 2 MG (as pitavastatin magnesium 2.053 MG) Oral Tablet	SY	c8c50e03-5cb8-43f4-bdef-8edd12f1945f	14
2001264	Zypitamag 2 MG Oral Tablet	SY	c8c50e03-5cb8-43f4-bdef-8edd12f1945f	14
2001268	Zypitamag 4 MG (as pitavastatin magnesium 4.106 MG) Oral Tablet	SY	c8c50e03-5cb8-43f4-bdef-8edd12f1945f	14
2001268	Zypitamag 4 MG Oral Tablet	SY	c8c50e03-5cb8-43f4-bdef-8edd12f1945f	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25208-202-09	25208020209	90 TABLET, FILM COATED in 1 BOTTLE (25208-202-09)		2018-03-09	0000-00-00	No	No	Current
25208-202-10	25208020210	1 BLISTER PACK in 1 CARTON (25208-202-10) > 7 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2018-03-09	0000-00-00	Yes	No	Current
25208-202-11	25208020211	1000 TABLET, FILM COATED in 1 BOTTLE (25208-202-11)		2018-03-09	0000-00-00	No	No	Current
25208-202-12	25208020212	10 BLISTER PACK in 1 CARTON (25208-202-12) > 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2018-03-09	0000-00-00	No	No	Current
25208-202-13	25208020213	30 TABLET, FILM COATED in 1 BOTTLE (25208-202-13)		2018-03-09	0000-00-00	No	No	Current
25208-202-14	25208020214	100 TABLET, FILM COATED in 1 BOTTLE (25208-202-14)		2018-03-09	0000-00-00	No	No	Current
25208-202-15	25208020215	500 TABLET, FILM COATED in 1 BOTTLE (25208-202-15)		2018-03-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZYPITAMAG	Medicure International Inc \| Zydus Pharmaceuticals (USA) Inc. \| Zydus Lifesciences Limited	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	14