lisinopril

Product NDC: 48433-332
11-digit product format: 484330332
Labeler code: 48433
Product ID: 48433-332_107ac38e-1a9b-40b2-b1e9-22f07e913397
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: Safecor Health, LLC
Application: ANDA075994
Marketing category: ANDA
Marketing start: 2014-10-01
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: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	48433-332		D	Discontinued by firm	2026-10-12
excluded package	package	48433-332	48433-332-10	D	Discontinued by firm	2026-10-12
excluded package	package	48433-332	48433-332-75	D	Discontinued by firm	2026-10-12

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 · 36 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	48433-332-75	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	48433-332-10	`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	48433-332-75	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	48433-332-10	`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	48433-332-75	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	48433-332-10	`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	48433-332-75	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	48433-332-10	`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	48433-332-75	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	48433-332-10	`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	48433-332-75	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	48433-332-10	`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	48433-332-75	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	48433-332-10	`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	48433-332-75	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	48433-332-10	`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	48433-332-75	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	48433-332-10	`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	48433-332-75	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	48433-332-10	`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	48433-332-75	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	48433-332-10	`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	48433-332-75	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	48433-332-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	TE codes	Approval date
A075994-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01
A075994-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01
A075994-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01
A075994-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01
A075994-005	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01
A075994-006	LISINOPRIL	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A075994-001	AB
A075994-002	AB
A075994-003	AB
A075994-004	AB
A075994-005	AB
A075994-006	AB

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075994-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075994-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075994-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075994-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075994-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075994-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075994-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075994-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075994-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075994-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075994-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075994-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075994-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075994-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075994-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075994-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075994-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075994-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075994-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075994-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075994-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075994-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075994-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075994-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075994-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075994-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075994-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075994-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075994-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075994-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075994-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075994-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075994-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075994-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075994-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075994-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075994-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075994-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075994-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075994-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A075994-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075994-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075994-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075994-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075994-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075994-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075994-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075994-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075994-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075994-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075994-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075994-006	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075994-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075994-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075994-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075994-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075994-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075994-006	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075994-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075994-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075994-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075994-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075994-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075994-006	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075994-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075994-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075994-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075994-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075994-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075994-006	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075994-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075994-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075994-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075994-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075994-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075994-006	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075994-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075994-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075994-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075994-004	AB	1	`3f01610625f2…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LISINOPRIL	ACTIVE INGREDIENT	E7199S1YWR	LISINOPRIL TABLET [SAFECOR HEALTH, LLC]	2
LISINOPRIL ANHYDROUS	ACTIVE MOIETY	7Q3P4BS2FD	LISINOPRIL TABLET [SAFECOR HEALTH, LLC]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	LISINOPRIL TABLET [SAFECOR HEALTH, LLC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LISINOPRIL TABLET [SAFECOR HEALTH, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LISINOPRIL TABLET [SAFECOR HEALTH, LLC]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LISINOPRIL TABLET [SAFECOR HEALTH, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LISINOPRIL TABLET [SAFECOR HEALTH, LLC]	2