PRINIVIL

Product NDC: 0006-0106
11-digit product format: 000060106
Labeler code: 0006
Product ID: 0006-0106_348b1bc3-e570-49ae-869e-1cb63874899f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: Merck Sharp & Dohme Corp.
Application: NDA019558
Marketing category: NDA
Marketing start: 1987-12-29
Marketing end: 0000-00-00
Substance: LISINOPRIL
Active strength: 10 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0006-0106		D	Discontinued by firm		2026-08-17
excluded package	package	0006-0106	0006-0106-54	D	Discontinued by firm		2026-08-17

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 · 24 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	0006-0106-54	`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	0006-0106-54	`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	0006-0106-54	`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	0006-0106-54	`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	0006-0106-54	`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	0006-0106-54	`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	0006-0106-54	`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	0006-0106-54	`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	0006-0106-54	`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	0006-0106-54	`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	0006-0106-54	`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	0006-0106-54	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019558-001	PRINIVIL	5MG	TABLET / ORAL	1987-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019558-002	PRINIVIL	10MG	TABLET / ORAL	1987-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019558-003	PRINIVIL	20MG	TABLET / ORAL	1987-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019558-004	PRINIVIL	40MG	TABLET / ORAL	1988-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019558-006	PRINIVIL	2.5MG	TABLET / ORAL	1994-01-28	`2680178bc6a6…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0006-0106-54	2020-07-22	C162847	48780-1	ab0e2407-2f3f-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use PRINIVIL safely and effectively. See full prescribing information for PRINIVIL. PRINIVIL ® (lisinopril) tablets, for oral use Initial U.S. Approval: 1987

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-0106-54	EA - Each	0006-0106	d31b3d4f-2376-4107-8ce9-0b02699c3036	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
lisinopril	ACTIVE INGREDIENT	E7199S1YWR	PRINIVIL (LISINOPRIL) TABLET [MERCK SHARP & DOHME CORP.]	21
LISINOPRIL ANHYDROUS	ACTIVE MOIETY	7Q3P4BS2FD	PRINIVIL (LISINOPRIL) TABLET [MERCK SHARP & DOHME CORP.]	21
calcium phosphate, dibasic, dihydrate	INACTIVE INGREDIENT	O7TSZ97GEP	PRINIVIL (LISINOPRIL) TABLET [MERCK SHARP & DOHME CORP.]	21
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	PRINIVIL (LISINOPRIL) TABLET [MERCK SHARP & DOHME CORP.]	21
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	PRINIVIL (LISINOPRIL) TABLET [MERCK SHARP & DOHME CORP.]	21
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PRINIVIL (LISINOPRIL) TABLET [MERCK SHARP & DOHME CORP.]	21
mannitol	INACTIVE INGREDIENT	3OWL53L36A	PRINIVIL (LISINOPRIL) TABLET [MERCK SHARP & DOHME CORP.]	21
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	PRINIVIL (LISINOPRIL) TABLET [MERCK SHARP & DOHME CORP.]	21

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
E7199S1YWR	LISINOPRIL	83915-83-7	LISINOPRIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0006-0106-54	00006010654	90 TABLET in 1 BOTTLE (0006-0106-54)	90 tablet	1987-12-29	0000-00-00	No	No	Current