Prestalia

Product NDC: 61894-011
11-digit product format: 618940011
Labeler code: 61894
Product ID: 61894-011_0d7199f6-3d4e-4391-85d2-dce6b15d8188
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: perindopril arginine, amlodipine besylate
Dosage form: TABLET
Route: ORAL
Labeler: Marina BioTech
Application: NDA205003
Marketing category: NDA
Marketing start: 2015-01-26
Marketing end: 2020-04-30
Substance: PERINDOPRIL ARGININE; AMLODIPINE BESYLATE
Active strength: 7 mg/1; mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61894-011		D	Discontinued by firm	2026-10-05
excluded package	package	61894-011	61894-011-02	D	Discontinued by firm	2026-10-05
excluded package	package	61894-011	61894-011-03	D	Discontinued by firm	2026-10-05

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 · 36 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	61894-011-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61894-011-03	`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	61894-011-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61894-011-03	`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	61894-011-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61894-011-03	`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	61894-011-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61894-011-03	`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	61894-011-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61894-011-03	`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	61894-011-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61894-011-03	`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	61894-011-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61894-011-03	`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	61894-011-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61894-011-03	`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	61894-011-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61894-011-03	`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	61894-011-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61894-011-03	`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	61894-011-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61894-011-03	`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	61894-011-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61894-011-03	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N205003-001	PRESTALIA	AMLODIPINE BESYLATE; PERINDOPRIL ARGININE	EQ 2.5MG BASE;3.5MG	TABLET / ORAL	RLD	2015-01-21
N205003-002	PRESTALIA	AMLODIPINE BESYLATE; PERINDOPRIL ARGININE	EQ 5MG BASE;7MG	TABLET / ORAL	RLD	2015-01-21
N205003-003	PRESTALIA	AMLODIPINE BESYLATE; PERINDOPRIL ARGININE	EQ 10MG BASE;14MG	TABLET / ORAL	RLD	2015-01-21

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205003-001	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29
N205003-002	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29
N205003-003	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29

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	N205003-001	PRESTALIA	EQ 2.5MG BASE;3.5MG	TABLET / ORAL	RLD	2015-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205003-002	PRESTALIA	EQ 5MG BASE;7MG	TABLET / ORAL	RLD	2015-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205003-003	PRESTALIA	EQ 10MG BASE;14MG	TABLET / ORAL	RLD	2015-01-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205003-001	PRESTALIA	EQ 2.5MG BASE;3.5MG	TABLET / ORAL	RLD	2015-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205003-002	PRESTALIA	EQ 5MG BASE;7MG	TABLET / ORAL	RLD	2015-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205003-003	PRESTALIA	EQ 10MG BASE;14MG	TABLET / ORAL	RLD	2015-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205003-001	PRESTALIA	EQ 2.5MG BASE;3.5MG	TABLET / ORAL	RLD	2015-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205003-002	PRESTALIA	EQ 5MG BASE;7MG	TABLET / ORAL	RLD	2015-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205003-003	PRESTALIA	EQ 10MG BASE;14MG	TABLET / ORAL	RLD	2015-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205003-001	PRESTALIA	EQ 2.5MG BASE;3.5MG	TABLET / ORAL	RLD	2015-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205003-002	PRESTALIA	EQ 5MG BASE;7MG	TABLET / ORAL	RLD	2015-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205003-003	PRESTALIA	EQ 10MG BASE;14MG	TABLET / ORAL	RLD	2015-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205003-001	PRESTALIA	EQ 2.5MG BASE;3.5MG	TABLET / ORAL	RLD	2015-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205003-002	PRESTALIA	EQ 5MG BASE;7MG	TABLET / ORAL	RLD	2015-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205003-003	PRESTALIA	EQ 10MG BASE;14MG	TABLET / ORAL	RLD	2015-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205003-001	PRESTALIA	EQ 2.5MG BASE;3.5MG	TABLET / ORAL	RLD	2015-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205003-002	PRESTALIA	EQ 5MG BASE;7MG	TABLET / ORAL	RLD	2015-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205003-003	PRESTALIA	EQ 10MG BASE;14MG	TABLET / ORAL	RLD	2015-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205003-001	PRESTALIA	EQ 2.5MG BASE;3.5MG	TABLET / ORAL	RLD	2015-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205003-002	PRESTALIA	EQ 5MG BASE;7MG	TABLET / ORAL	RLD	2015-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205003-003	PRESTALIA	EQ 10MG BASE;14MG	TABLET / ORAL	RLD	2015-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205003-001	PRESTALIA	EQ 2.5MG BASE;3.5MG	TABLET / ORAL	RLD	2015-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205003-002	PRESTALIA	EQ 5MG BASE;7MG	TABLET / ORAL	RLD	2015-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205003-003	PRESTALIA	EQ 10MG BASE;14MG	TABLET / ORAL	RLD	2015-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205003-001	PRESTALIA	EQ 2.5MG BASE;3.5MG	TABLET / ORAL	RLD	2015-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205003-002	PRESTALIA	EQ 5MG BASE;7MG	TABLET / ORAL	RLD	2015-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205003-003	PRESTALIA	EQ 10MG BASE;14MG	TABLET / ORAL	RLD	2015-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205003-001	PRESTALIA	EQ 2.5MG BASE;3.5MG	TABLET / ORAL	RLD	2015-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205003-002	PRESTALIA	EQ 5MG BASE;7MG	TABLET / ORAL	RLD	2015-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205003-003	PRESTALIA	EQ 10MG BASE;14MG	TABLET / ORAL	RLD, RS	2015-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205003-001	PRESTALIA	EQ 2.5MG BASE;3.5MG	TABLET / ORAL	RLD	2015-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205003-002	PRESTALIA	EQ 5MG BASE;7MG	TABLET / ORAL	RLD	2015-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205003-003	PRESTALIA	EQ 10MG BASE;14MG	TABLET / ORAL	RLD	2015-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205003-001	PRESTALIA	EQ 2.5MG BASE;3.5MG	TABLET / ORAL	RLD	2015-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205003-002	PRESTALIA	EQ 5MG BASE;7MG	TABLET / ORAL	RLD	2015-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205003-003	PRESTALIA	EQ 10MG BASE;14MG	TABLET / ORAL	RLD	2015-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205003-001	PRESTALIA	EQ 2.5MG BASE;3.5MG	TABLET / ORAL	RLD	2015-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205003-002	PRESTALIA	EQ 5MG BASE;7MG	TABLET / ORAL	RLD	2015-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205003-003	PRESTALIA	EQ 10MG BASE;14MG	TABLET / ORAL	RLD, RS	2015-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205003-001	PRESTALIA	EQ 2.5MG BASE;3.5MG	TABLET / ORAL	RLD	2015-01-21	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 201 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N205003-001	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205003-002	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205003-003	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205003-001	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205003-002	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205003-003	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205003-001	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205003-002	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205003-003	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205003-001	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205003-002	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205003-003	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205003-001	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205003-002	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205003-003	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205003-001	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205003-002	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205003-003	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205003-001	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205003-002	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205003-003	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205003-001	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205003-002	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205003-003	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205003-001	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205003-002	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205003-003	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205003-001	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205003-002	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205003-003	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205003-001	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205003-002	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205003-003	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205003-001	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205003-002	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205003-003	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205003-001	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205003-002	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205003-003	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205003-001	7846961	2029-10-05	U-3	Drug substance, Drug product	2015-12-29	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61894-011-02	EA - Each	61894-011	f304fc6b-d9ab-40f0-80ab-9615d108f077	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
amlodipine besylate	ACTIVE INGREDIENT	864V2Q084H	PRESTALIA (PERINDOPRIL ARGININE, AMLODIPINE BESYLATE) TABLET [SYMPLMED PHARMACEUTICALS, LLC]	3
perindopril arginine	ACTIVE INGREDIENT	TFT5IM1KGB	PRESTALIA (PERINDOPRIL ARGININE, AMLODIPINE BESYLATE) TABLET [SYMPLMED PHARMACEUTICALS, LLC]	3
amlodipine	ACTIVE MOIETY	1J444QC288	PRESTALIA (PERINDOPRIL ARGININE, AMLODIPINE BESYLATE) TABLET [SYMPLMED PHARMACEUTICALS, LLC]	3
perindoprilat	ACTIVE MOIETY	2UV6ZNQ92K	PRESTALIA (PERINDOPRIL ARGININE, AMLODIPINE BESYLATE) TABLET [SYMPLMED PHARMACEUTICALS, LLC]	3
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	PRESTALIA (PERINDOPRIL ARGININE, AMLODIPINE BESYLATE) TABLET [SYMPLMED PHARMACEUTICALS, LLC]	3
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PRESTALIA (PERINDOPRIL ARGININE, AMLODIPINE BESYLATE) TABLET [SYMPLMED PHARMACEUTICALS, LLC]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PRESTALIA (PERINDOPRIL ARGININE, AMLODIPINE BESYLATE) TABLET [SYMPLMED PHARMACEUTICALS, LLC]	3
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	PRESTALIA (PERINDOPRIL ARGININE, AMLODIPINE BESYLATE) TABLET [SYMPLMED PHARMACEUTICALS, LLC]	3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TFT5IM1KGB	PERINDOPRIL ARGININE	612548-45-5	PERINDOPRIL ARGININE
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prestalia	Marina BioTech \| Patheon Pharmaceuticals Inc.	2019-10-14	HUMAN PRESCRIPTION DRUG LABEL	10