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 6 of 8 · 156 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril	LISINOPRIL	NCS HealthCare of KY, LLC dba Vangard Labs	43fa9a16-c112-419f-8d7b-177f580462f2	2024-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
Lisinopril	LISINOPRIL	American Health Packaging	50ae0dfe-d961-4bc0-9898-71f69f9a5403	2024-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Camber Pharmaceuticals, Inc.	387068e7-7fb9-44f3-ae1c-e45ebc755a3e	2024-08-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Solco healthcare U.S., LLC	e299d477-a612-4af4-b6aa-f5addc8a736d	2024-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Bryant Ranch Prepack	1ec55dd0-9ed5-40d2-978e-9fe773f2281a	2024-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals, Inc.	4aa518e1-d989-1fde-e054-00144ff88e88	2024-07-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals, Inc.	4aa44af9-1aff-314c-e054-00144ff8d46c	2024-07-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	6f7f5697-acb0-ea95-e053-2991aa0ae7c7	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	6314e49c-8715-2f01-e053-2a91aa0ab2a5	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
Lisinopril	LISINOPRIL	NuCare Pharmaceuticals,Inc.	ab9bc1b4-60cc-76ea-e053-2995a90ac203	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	5a1c5b04-b78c-c057-e053-2991aa0aa916	2024-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	5786b8d9-3818-66a5-e053-2991aa0a7025	2024-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals, Inc.	51c80515-b26d-5776-e054-00144ff8d46c	2024-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
Lisinopril	LISINOPRIL	NuCare Pharmaceuticals,Inc.	90a589a9-acc2-bfbe-e053-2995a90a0bd2	2024-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	9148529f-6278-e507-e053-2995a90aa4cf	2024-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
Lisinopril	LISINOPRIL	NuCare Pharmaceuticals,Inc.	95376981-4620-c9aa-e053-2995a90a1390	2024-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	86e7a336-c416-6fab-e053-2a91aa0a274c	2024-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
Lisinopril	LISINOPRIL	NuCare Pharmaceuticals,Inc.	7cd7c59d-ce52-1f5b-e053-2a91aa0a8f86	2024-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Exelan Pharmaceuticals, Inc	4aad4d30-3e18-489c-80ad-ccf7532bb933	2024-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	54dc1e7e-6abd-4f6d-8b41-2b2731d51a65	2024-02-15	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