Application 019558

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRINIVIL	LISINOPRIL	TABLET;ORAL	5MG	No	No
002	PRINIVIL	LISINOPRIL	TABLET;ORAL	10MG	No	No
003	PRINIVIL	LISINOPRIL	TABLET;ORAL	20MG	No	No
004	PRINIVIL	LISINOPRIL	TABLET;ORAL	40MG	No	No
006	PRINIVIL	LISINOPRIL	TABLET;ORAL	2.5MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N019558-001	PRINIVIL	LISINOPRIL	5MG	TABLET / ORAL	1987-12-29
N019558-002	PRINIVIL	LISINOPRIL	10MG	TABLET / ORAL	1987-12-29
N019558-003	PRINIVIL	LISINOPRIL	20MG	TABLET / ORAL	1987-12-29
N019558-004	PRINIVIL	LISINOPRIL	40MG	TABLET / ORAL	1988-10-25
N019558-006	PRINIVIL	LISINOPRIL	2.5MG	TABLET / ORAL	1994-01-28

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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019558-001	PRINIVIL	5MG	TABLET / ORAL	1987-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019558-002	PRINIVIL	10MG	TABLET / ORAL	1987-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019558-003	PRINIVIL	20MG	TABLET / ORAL	1987-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019558-004	PRINIVIL	40MG	TABLET / ORAL	1988-10-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019558-006	PRINIVIL	2.5MG	TABLET / ORAL	1994-01-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019558-001	PRINIVIL	5MG	TABLET / ORAL	1987-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019558-002	PRINIVIL	10MG	TABLET / ORAL	1987-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019558-003	PRINIVIL	20MG	TABLET / ORAL	1987-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019558-004	PRINIVIL	40MG	TABLET / ORAL	1988-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019558-006	PRINIVIL	2.5MG	TABLET / ORAL	1994-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019558-001	PRINIVIL	5MG	TABLET / ORAL	1987-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019558-002	PRINIVIL	10MG	TABLET / ORAL	1987-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019558-003	PRINIVIL	20MG	TABLET / ORAL	1987-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019558-004	PRINIVIL	40MG	TABLET / ORAL	1988-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019558-006	PRINIVIL	2.5MG	TABLET / ORAL	1994-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019558-001	PRINIVIL	5MG	TABLET / ORAL	1987-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019558-002	PRINIVIL	10MG	TABLET / ORAL	1987-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019558-003	PRINIVIL	20MG	TABLET / ORAL	1987-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019558-004	PRINIVIL	40MG	TABLET / ORAL	1988-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019558-006	PRINIVIL	2.5MG	TABLET / ORAL	1994-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019558-001	PRINIVIL	5MG	TABLET / ORAL	1987-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019558-002	PRINIVIL	10MG	TABLET / ORAL	1987-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019558-003	PRINIVIL	20MG	TABLET / ORAL	1987-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019558-004	PRINIVIL	40MG	TABLET / ORAL	1988-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019558-006	PRINIVIL	2.5MG	TABLET / ORAL	1994-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019558-001	PRINIVIL	5MG	TABLET / ORAL	1987-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019558-002	PRINIVIL	10MG	TABLET / ORAL	1987-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019558-003	PRINIVIL	20MG	TABLET / ORAL	1987-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019558-004	PRINIVIL	40MG	TABLET / ORAL	1988-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019558-006	PRINIVIL	2.5MG	TABLET / ORAL	1994-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019558-001	PRINIVIL	5MG	TABLET / ORAL	1987-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019558-002	PRINIVIL	10MG	TABLET / ORAL	1987-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019558-003	PRINIVIL	20MG	TABLET / ORAL	1987-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019558-004	PRINIVIL	40MG	TABLET / ORAL	1988-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019558-006	PRINIVIL	2.5MG	TABLET / ORAL	1994-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019558-001	PRINIVIL	5MG	TABLET / ORAL	1987-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019558-002	PRINIVIL	10MG	TABLET / ORAL	1987-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019558-003	PRINIVIL	20MG	TABLET / ORAL	1987-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019558-004	PRINIVIL	40MG	TABLET / ORAL	1988-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019558-006	PRINIVIL	2.5MG	TABLET / ORAL	1994-01-28	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	N019558-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019558-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019558-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019558-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019558-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019558-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019558-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019558-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019558-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019558-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019558-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019558-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019558-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019558-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019558-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019558-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019558-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019558-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019558-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019558-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019558-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019558-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019558-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019558-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019558-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019558-004	AB	1	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 8 · 156 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril	LISINOPRIL	A-S Medication Solutions	cce5bcc0-2e38-41d8-a41e-4f4ea83e6248	2024-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Bryant Ranch Prepack	3783ab4c-2bed-414e-8927-62d47e3e3496	2024-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Bryant Ranch Prepack	5af2444f-438c-4ea6-96e8-3dba1af9e1a5	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
Lisinopril	LISINOPRIL	A-S Medication Solutions	24aab432-9c51-4aee-b9b6-f38816d613bb	2024-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	aeee8e9a-333a-416e-ab69-a0d40e146883	2024-01-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Proficient Rx LP	726a6f23-737a-4866-b4ba-b3c18cd2e1ac	2024-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	a32db461-4f77-46ef-b49b-250711dade17	2023-12-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	a79a034d-7bbb-4b05-b8fc-8ebf09f33c0c	2023-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	719c4db7-ccbe-4779-baa7-a3c461f3aa52	2023-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	021831ab-dfeb-40fc-aede-4aa1fbb8d918	2023-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
lisinopril	LISINOPRIL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901)	c6c55efa-36bd-4613-98ca-2eb589a31e53	2023-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Proficient Rx LP	3f6bc45e-448e-47f9-9bc4-991b1c503ddf	2023-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Proficient Rx LP	e5fbefd1-4077-4e81-a0e3-e09fadc48593	2023-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
Lisinopril	LISINOPRIL	A-S Medication Solutions	24f678c8-bb66-481e-b42b-1367cbff3169	2023-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
Lisinopril	LISINOPRIL	A-S Medication Solutions	051375d4-7d38-45b3-9ca4-f2cd1f527b1b	2023-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	b5683ac4-59dc-4772-8bc6-984c698afbeb	2023-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Proficient Rx LP	ad211de8-d236-48aa-bf27-4501eccfffca	2023-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Solco healthcare U.S., LLC	f8d16c85-50e2-4d99-afae-6fb902734e42	2022-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Proficient Rx LP	b2d493bf-f4d8-4941-8c54-2728d769f6ed	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Proficient Rx LP	3e4e69f6-b8a6-462d-a7ec-4cd6636512d0	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-0019	PRINIVIL	lisinopril	Merck Sharp & Dohme Corp.	NDA	Current
0006-0019	PRINIVIL	lisinopril	Merck Sharp & Dohme Corp.	NDA	Current
0006-0019	PRINIVIL	lisinopril	Merck Sharp & Dohme Corp.	NDA	Current
0006-0019	PRINIVIL	lisinopril	Merck Sharp & Dohme Corp.	NDA	Current
0006-0019	PRINIVIL	lisinopril	Merck Sharp & Dohme Corp.	NDA	Current
0006-0106	PRINIVIL	lisinopril	Merck Sharp & Dohme Corp.	NDA	Current
0006-0106	PRINIVIL	lisinopril	Merck Sharp & Dohme Corp.	NDA	Current
0006-0106	PRINIVIL	lisinopril	Merck Sharp & Dohme Corp.	NDA	Current
0006-0106	PRINIVIL	lisinopril	Merck Sharp & Dohme Corp.	NDA	Current
0006-0106	PRINIVIL	lisinopril	Merck Sharp & Dohme Corp.	NDA	Current
0006-0207	PRINIVIL	lisinopril	Merck Sharp & Dohme Corp.	NDA	Current
0006-0207	PRINIVIL	lisinopril	Merck Sharp & Dohme Corp.	NDA	Current
0006-0207	PRINIVIL	lisinopril	Merck Sharp & Dohme Corp.	NDA	Current
0006-0207	PRINIVIL	lisinopril	Merck Sharp & Dohme Corp.	NDA	Current
0006-0207	PRINIVIL	lisinopril	Merck Sharp & Dohme Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69288	SUPPL	2021-11-10
69286	SUPPL	2021-11-10
55964	SUPPL	2018-10-17
55912	SUPPL	2018-10-15
49844	SUPPL	2017-09-22
49813	SUPPL	2017-09-20
45556	SUPPL	2016-10-19
45625	SUPPL	2016-10-17
33799	SUPPL	2015-09-03
17459	SUPPL	2015-09-01
11535	SUPPL	2015-07-13
1390	SUPPL	2015-07-13
11534	SUPPL	2013-03-01
1389	SUPPL	2013-02-28
11533	SUPPL	2012-06-11
1388	SUPPL	2012-06-08
17458	SUPPL	2011-11-21
11532	SUPPL	2011-11-21
1387	SUPPL	2011-06-17
17457	SUPPL	2008-10-14
1386	SUPPL	2008-10-14
1385	SUPPL	2007-02-12
1384	SUPPL	2006-10-23
17456	SUPPL	2006-06-20
44034	ORIG	2006-06-09
1383	SUPPL	2005-10-11
20263	SUPPL	2005-04-17
11530	ORIG	2004-06-14
1381	ORIG	2004-06-14
17454	SUPPL	2004-05-07
17455	SUPPL	2004-03-03
11531	SUPPL	2003-06-08
1382	SUPPL	2003-06-08
20262	SUPPL	2001-06-22