Prestalia

Product NDC: 72931-010
11-digit product format: 729310010
Labeler code: 72931
Product ID: 72931-010_cc9b436d-0d79-47c6-b001-878fcb233384
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: perindopril arginine and amlodipine besylate
Dosage form: TABLET
Route: ORAL
Labeler: Adhera Therapeutics, Inc.
Application: NDA205003
Marketing category: NDA
Marketing start: 2015-01-26
Marketing end: 0000-00-00
Substance: PERINDOPRIL ARGININE; AMLODIPINE BESYLATE
Active strength: 4 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: 2020-12-31
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	72931-010		I	Inactivated by FDA	2026-10-05
excluded package	package	72931-010	72931-010-02	I	Inactivated by FDA	2026-10-05
excluded package	package	72931-010	72931-010-03	I	Inactivated by FDA	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 · 45 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	72931-010-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72931-010-03	`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	72931-010-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72931-010-03	`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	72931-010-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72931-010-03	`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	72931-010-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72931-010-03	`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	72931-010-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72931-010-03	`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	72931-010-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72931-010-03	`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	72931-010-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72931-010-03	`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	72931-010-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72931-010-03	`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	72931-010-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72931-010-03	`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	72931-010-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72931-010-03	`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	72931-010-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72931-010-03	`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	72931-010-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	72931-010-03	`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	72931-010-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	72931-010-03	`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	72931-010-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	72931-010-03	`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	72931-010-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	72931-010-03	`1332a3947898…`	`d4bfe170f9cd…`

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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa898d56-9495-d6f0-309b-68a5d8e3914a	Product name	4	20260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
265792b3-b999-c010-7364-a7db20b9d4d9	Product name	5	20250515
14c2c15b-f823-4ada-a40e-a440544294dc	Product name	1	20221207
a72887ef-d675-499f-af4b-78688f6855cd	Product name	1	20191002
a4484670-2869-6416-f6ff-03b1b3cbd1b0	Product name	2	20190415
4a27501f-a987-48a5-99b4-e983d4744d76	Product name	7	20181211
18600d07-613d-bf9c-2711-fe40c06f3393	Product name	5	20180703
bded1554-44de-900a-5297-403365d6d4b2	Product name	3	20170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1	Product name	1	20150316
b7225d76-59fc-c13f-c287-78d1c893ca87	Product name	2	20150206
63ab5fbf-2a6b-c41d-051a-39e845d718b1	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72931-010-02	2023-01-30	C162847	48780-1	f386c649-9ba9-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use PRESTALIA ® tablets safely and effectively. See full prescribing information for PRESTALIA. PRESTALIA (perindopril arginine and amlodipine) tablets, for oral use. Initial U.S. Approval: 2015
72931-010-03	2023-01-30	C162847	48780-1	f386c649-9ba9-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use PRESTALIA ® tablets safely and effectively. See full prescribing information for PRESTALIA. PRESTALIA (perindopril arginine and amlodipine) tablets, for oral use. Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72931-010-02	Prestalia	90 in 1 BOTTLE, PLASTIC	TABLET	90		1
72931-010-03	Prestalia	7 in 1 BOTTLE	TABLET	7		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72931-010-02	EA - Each	72931-010	7f7bb9e1-2f0b-42fe-b736-2f93f5ab6fb3	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72931-010	PRESTALIA (PERINDOPRIL ARGININE AND AMLODIPINE BESYLATE) TABLET [ADHERA THERAPEUTICS, INC.]	1	Legacy NDC, 2 package rows	20191106_eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1600716	perindopril arginine 14 MG / amLODIPine 10 MG Oral Tablet	PSN	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600724	perindopril arginine 3.5 MG / amLODIPine 2.5 MG Oral Tablet	PSN	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600728	perindopril arginine 7 MG / amLODIPine 5 MG Oral Tablet	PSN	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600722	Prestalia 14 MG / 10 MG Oral Tablet	PSN	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600726	Prestalia 3.5 MG / 2.5 MG Oral Tablet	PSN	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600730	Prestalia 7 MG / 5 MG Oral Tablet	PSN	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600722	amlodipine 10 MG / perindopril arginine 14 MG Oral Tablet [Prestalia]	SBD	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600726	amlodipine 2.5 MG / perindopril arginine 3.5 MG Oral Tablet [Prestalia]	SBD	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600730	amlodipine 5 MG / perindopril arginine 7 MG Oral Tablet [Prestalia]	SBD	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600716	amlodipine 10 MG / perindopril arginine 14 MG Oral Tablet	SCD	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600724	amlodipine 2.5 MG / perindopril arginine 3.5 MG Oral Tablet	SCD	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600728	amlodipine 5 MG / perindopril arginine 7 MG Oral Tablet	SCD	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600716	amlodipine 10 MG (as amlodipine besylate 13.87 MG) / perindopril arginine 14 MG (perindopril 9.51 MG) Oral Tablet	SY	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600724	amlodipine 2.5 MG (as amlodipine besylate 3.47 MG) / perindopril arginine 3.5 MG (perindopril 2.38 MG) Oral Tablet	SY	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600728	amlodipine 5 MG (as amlodipine besylate 6.94 MG) / perindopril arginine 7 MG (perindopril 4.76 MG) Oral Tablet	SY	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600722	Prestalia (amlodipine 10 MG (as amlodipine besylate 13.87 MG) / perindopril arginine 14 MG (perindopril 9.51 MG)) Oral Tablet	SY	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600726	Prestalia (amlodipine 2.5 MG (as amlodipine besylate 3.47 MG) / perindopril arginine 3.5 MG (perindopril 2.38 MG)) Oral Tablet	SY	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600730	Prestalia (amlodipine 5 MG (as amlodipine besylate 6.94 MG) / perindopril arginine 7 MG (perindopril 4.76 MG)) Oral Tablet	SY	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600722	Prestalia 14 MG / 10 MG Oral Tablet	SY	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600726	Prestalia 3.5 MG / 2.5 MG Oral Tablet	SY	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1
1600730	Prestalia 7 MG / 5 MG Oral Tablet	SY	eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72931-010-02	72931001002	90 TABLET in 1 BOTTLE, PLASTIC (72931-010-02)	90 tablet	2015-01-26	0000-00-00	No	No	Current
72931-010-03	72931001003	7 TABLET in 1 BOTTLE (72931-010-03)	7 tablet	2018-06-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prestalia	Adhera Therapeutics, Inc. \| Patheon Pharmaceuticals Inc	2019-10-25	HUMAN PRESCRIPTION DRUG LABEL	1