Lisinopril

Product NDC: 67046-0422
11-digit product format: 670460422
Labeler code: 67046
Product ID: 67046-0422_538433d4-61d0-d2cf-e063-6394a90a5099
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA077321
Marketing category: ANDA
Marketing start: 2026-06-05
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: 2027-12-31
Current FDA listing: Yes

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
A077321-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09
A077321-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09
A077321-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09
A077321-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09
A077321-005	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09
A077321-006	LISINOPRIL	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077321-001	AB
A077321-002	AB
A077321-003	AB
A077321-004	AB
A077321-005	AB
A077321-006	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	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2005-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2005-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2005-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2005-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2005-09-09	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077321-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077321-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077321-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077321-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077321-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077321-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077321-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077321-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077321-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077321-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077321-004	AB	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Lisinopril
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LISINOPRIL	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
E7199S1YWR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314076	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
538429b8-4f10-e825-e063-6294a90a5905	Available on FDA.report

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 1 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	aa5d68e7-c2b9-41eb-ade4-2cd57edc1533	2026-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	463308ef-16cb-41d8-8d29-6aae2c5a7b0f	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	34bb4602-ccff-4939-91b9-26a63bfd40f7	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	a33d860a-1e17-45b7-aede-51ab3223bebd	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	A-S Medication Solutions	88b5a2c0-6ad2-48e7-9ffe-715d9159f389	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	A-S Medication Solutions	34953f77-bae1-41fe-af11-3ea0b3ceaa11	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	3451292b-7867-4dc2-afaa-da66b4016017	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	d32923fe-a323-43c6-af46-bcba7274b0bf	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Unit Dose Solutions, Inc.	551665a0-9a92-55df-e063-6394a90a1e2e	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Unit Dose Solutions, Inc.	55189717-f5db-9c63-e063-6294a90a6bc9	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Unit Dose Solutions, Inc.	55191baa-f812-2e71-e063-6294a90a8edf	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	PD-Rx Pharmaceuticals, Inc.	c621c33b-cb67-4ea6-b2bd-96c20a244ea4	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Coupler LLC	538429b8-4f10-e825-e063-6294a90a5905	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321 ndc (product): 67046-0422
Lisinopril	LISINOPRIL	Cardinal Health 107, LLC	1d0caa63-9ea2-4a97-a23b-900a7c514bc6	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Coupler LLC	518a63e3-8ca1-bbd1-e063-6294a90aa524	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Coupler LLC	509a46cf-7a89-b6c0-e063-6394a90a7509	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Bryant Ranch Prepack	08b0555e-41d2-44c3-b27b-ad5d701378dc	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	Bryant Ranch Prepack	59fd2167-4da4-9143-83bd-3b6aa5051511	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	a35079fa-b693-45e8-9715-488e33e7c1a9	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	f22bfb4d-dda6-4c7f-a485-cfb7710ef3de	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077321 application number: ANDA077321

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	Sample	Exclude flag	Status
67046-0422-3	67046042203	30 TABLET in 1 BLISTER PACK (67046-0422-3)	30 tablet	2026-06-05	No	No	Current