Lisinopril

Product NDC: 63629-7445
11-digit product format: 636297445
Labeler code: 63629
Product ID: 63629-7445_8b23407c-cdff-47a0-af94-db354b5c7815
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA076063
Marketing category: ANDA
Marketing start: 2013-02-13
Marketing end: 0000-00-00
Substance: LISINOPRIL
Active strength: 5 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	63629-7445		D	Discontinued by firm		2026-08-17
excluded package	package	63629-7445	63629-7445-1	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 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-7445-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-7445-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-7445-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-7445-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-7445-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-7445-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-7445-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-7445-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-7445-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-7445-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-7445-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-7445-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-7445-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076063-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01
A076063-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01
A076063-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01
A076063-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01
A076063-005	LISINOPRIL	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01
A076063-006	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	2003-06-27

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 7 · 252 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	A076063-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076063-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076063-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076063-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076063-005	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076063-006	LISINOPRIL	30MG	TABLET / ORAL	2003-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076063-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076063-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076063-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076063-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076063-005	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076063-006	LISINOPRIL	30MG	TABLET / ORAL	2003-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076063-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076063-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076063-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076063-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076063-005	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076063-006	LISINOPRIL	30MG	TABLET / ORAL	2003-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076063-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076063-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076063-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076063-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076063-005	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076063-006	LISINOPRIL	30MG	TABLET / ORAL	2003-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076063-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076063-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076063-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076063-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076063-005	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076063-006	LISINOPRIL	30MG	TABLET / ORAL	2003-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076063-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076063-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076063-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076063-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076063-005	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076063-006	LISINOPRIL	30MG	TABLET / ORAL	2003-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076063-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076063-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076063-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076063-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076063-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076063-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076063-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076063-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076063-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076063-006	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076063-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076063-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076063-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076063-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076063-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076063-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076063-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076063-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076063-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076063-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076063-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076063-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076063-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076063-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076063-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076063-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076063-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076063-006	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-7445-1	2020-10-16	C162847	48780-1	9d75b9cf-ec99-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use lisinopril tablets safely and effectively. See full prescribing information for lisinopril tablets. Lisinopril Tablets, USP, for oral use Initial U.S. Approval: 1988
63629-7445-1	2020-01-31	C162847	48780-1	9d75b9cf-ec99-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use lisinopril tablets safely and effectively. See full prescribing information for lisinopril tablets. Lisinopril Tablets, USP, for oral use Initial U.S. Approval: 1988

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
63629-7445-1	63629744501	30 TABLET in 1 BOTTLE (63629-7445-1)	30 tablet	2017-11-24	0000-00-00	No	No	Current