Lisinopril

Product NDC: 66116-310
11-digit product format: 661160310
Labeler code: 66116
Product ID: 66116-310_cd217f3c-5a6e-4def-a125-e70ad4874e9b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: MedVantx, Inc.
Application: ANDA075752
Marketing category: ANDA
Marketing start: 2002-07-01
Marketing end: 0000-00-00
Substance: LISINOPRIL
Active strength: 20 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	66116-310		I	Inactivated by FDA		2026-10-05
excluded package	package	66116-310	66116-310-30	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 · 44 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	66116-310-30	`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	66116-310-30	`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	66116-310-30	`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	66116-310-30	`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	66116-310-30	`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	66116-310-30	`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	66116-310-30	`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	66116-310-30	`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	66116-310-30	`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	66116-310-30	`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	66116-310-30	`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	66116-310-30	`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	66116-310-30	`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	66116-310-30	`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	66116-310-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	66116-310-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	66116-310-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	66116-310-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	66116-310-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	66116-310-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	66116-310-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	66116-310-30	`110d247fa046…`	`a55b01930146…`

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

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
A075752-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01
A075752-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01
A075752-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01
A075752-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01
A075752-005	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	2002-07-01
A075752-006	LISINOPRIL	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01

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 · 258 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	A075752-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075752-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075752-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075752-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075752-005	LISINOPRIL	30MG	TABLET / ORAL	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075752-006	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075752-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075752-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075752-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075752-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075752-005	LISINOPRIL	30MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075752-006	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075752-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075752-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075752-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075752-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075752-005	LISINOPRIL	30MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075752-006	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075752-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075752-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075752-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075752-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075752-005	LISINOPRIL	30MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075752-006	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075752-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075752-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075752-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075752-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075752-005	LISINOPRIL	30MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075752-006	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075752-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075752-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075752-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075752-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075752-005	LISINOPRIL	30MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075752-006	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075752-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075752-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075752-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075752-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A075752-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075752-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075752-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075752-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075752-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075752-006	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075752-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075752-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075752-003	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075752-004	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075752-005	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075752-006	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075752-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075752-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075752-003	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075752-004	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075752-005	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075752-006	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075752-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075752-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075752-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075752-004	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075752-005	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075752-006	AB	1	`053a50430f4f…`

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
f8f05a6d-f74b-4e9e-ab1c-374d3b4fb820	Product name	1	20230703
f65307a7-3644-0a09-cdfd-94aae8d3b53e	Product name	3	20210902
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66116-310-30	2019-11-27	C162847	48780-1	9855d018-d9eb-cd31-e053-dbdaa90ab51a	LISINOPRIL TABLETS USP Once-Daily

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66116-310-30	Lisinopril	30 in 1 BOTTLE	TABLET	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LISINOPRIL	ACTIVE INGREDIENT	E7199S1YWR	LISINOPRIL TABLET [MEDVANTX, INC.]	1
LISINOPRIL ANHYDROUS	ACTIVE MOIETY	7Q3P4BS2FD	LISINOPRIL TABLET [MEDVANTX, INC.]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	LISINOPRIL TABLET [MEDVANTX, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LISINOPRIL TABLET [MEDVANTX, INC.]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LISINOPRIL TABLET [MEDVANTX, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LISINOPRIL TABLET [MEDVANTX, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LISINOPRIL TABLET [MEDVANTX, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66116-310	LISINOPRIL TABLET [MEDVANTX, INC.]	1	Legacy NDC, 1 package rows	20130820_cd217f3c-5a6e-4def-a125-e70ad4874e9b.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314077	lisinopril 20 MG Oral Tablet	PSN	cd217f3c-5a6e-4def-a125-e70ad4874e9b	1
314077	lisinopril 20 MG Oral Tablet	SCD	cd217f3c-5a6e-4def-a125-e70ad4874e9b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
66116-310-30	66116031030	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LISINOPRIL TABLETS USP Once-Daily	MedVantx, Inc. \| IVAX Pharmaceuticals, Inc. \| Blenheim Pharmacal, Inc.	2013-01-23	HUMAN PRESCRIPTION DRUG LABEL	1