Application 077622

Type: ANDA
Sponsor: AUROBINDO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LISINOPRIL	LISINOPRIL	TABLET;ORAL	2.5MG	No	No
002	LISINOPRIL	LISINOPRIL	TABLET;ORAL	5MG	No	No
003	LISINOPRIL	LISINOPRIL	TABLET;ORAL	10MG	No	No
004	LISINOPRIL	LISINOPRIL	TABLET;ORAL	20MG	No	No
005	LISINOPRIL	LISINOPRIL	TABLET;ORAL	30MG	No	No
006	LISINOPRIL	LISINOPRIL	TABLET;ORAL	40MG	No	No

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
A077622-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2006-02-22
A077622-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	AB	2006-02-22
A077622-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	AB	2006-02-22
A077622-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	AB	2006-02-22
A077622-005	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	AB	2006-02-22
A077622-006	LISINOPRIL	LISINOPRIL	40MG	TABLET / ORAL	AB	2006-02-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077622-001	AB
A077622-002	AB
A077622-003	AB
A077622-004	AB
A077622-005	AB
A077622-006	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	A077622-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2006-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077622-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2006-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077622-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2006-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077622-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2006-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077622-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2006-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077622-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2006-02-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077622-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2006-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077622-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2006-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077622-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2006-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077622-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2006-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077622-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2006-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077622-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2006-02-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077622-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2006-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077622-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2006-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077622-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2006-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077622-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2006-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077622-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2006-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077622-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2006-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077622-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2006-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077622-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2006-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077622-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2006-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077622-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2006-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077622-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2006-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077622-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2006-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077622-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2006-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077622-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2006-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077622-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2006-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077622-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2006-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077622-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2006-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077622-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2006-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077622-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2006-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077622-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2006-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077622-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2006-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077622-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2006-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077622-005	LISINOPRIL	30MG	TABLET / ORAL	AB	2006-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077622-006	LISINOPRIL	40MG	TABLET / ORAL	AB	2006-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077622-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2006-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077622-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2006-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077622-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2006-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077622-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2006-02-22	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077622-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077622-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077622-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077622-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077622-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077622-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077622-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077622-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077622-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077622-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077622-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077622-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077622-005	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077622-006	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077622-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077622-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077622-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077622-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077622-005	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077622-006	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077622-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077622-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077622-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077622-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077622-005	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077622-006	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077622-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077622-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077622-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077622-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077622-005	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077622-006	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077622-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077622-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077622-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077622-004	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077622-005	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077622-006	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077622-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077622-002	AB	1	`301d65b070ca…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril	LISINOPRIL	Aurobindo Pharma Limited	0e6364a4-6d66-4151-8197-d45e2a762895	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077622 application number: ANDA077622 ndc (product): 65862-041 ndc (product): 65862-039 ndc (product): 65862-037 ndc (product): 65862-042 ndc (product): 65862-040 ndc (product): 65862-038

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-794	Lisinopril	Lisinopril	Rising Pharma Holdings, Inc.	ANDA	Current
16571-795	Lisinopril	Lisinopril	Rising Pharma Holdings, Inc.	ANDA	Current
16571-796	Lisinopril	Lisinopril	Rising Pharma Holdings, Inc.	ANDA	Current
16571-797	Lisinopril	Lisinopril	Rising Pharma Holdings, Inc.	ANDA	Current
16571-798	Lisinopril	Lisinopril	Rising Pharma Holdings, Inc.	ANDA	Current
16571-799	Lisinopril	Lisinopril	Rising Pharma Holdings, Inc.	ANDA	Current
53808-0617	Lisinopril	LISINOPRIL	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0700	Lisinopril	LISINOPRIL	State of Florida DOH Central Pharmacy	ANDA	Current
57237-052	Lisinopril	Lisinopril	Citron Pharma LLC	ANDA	Current
57237-053	Lisinopril	Lisinopril	Citron Pharma LLC	ANDA	Current
57237-054	Lisinopril	Lisinopril	Citron Pharma LLC	ANDA	Current
57237-055	Lisinopril	Lisinopril	Citron Pharma LLC	ANDA	Current
57237-056	Lisinopril	Lisinopril	Citron Pharma LLC	ANDA	Current
57237-057	Lisinopril	Lisinopril	Citron Pharma LLC	ANDA	Current
65862-037	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-037	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-037	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-037	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-037	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-038	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-038	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-038	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-038	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-038	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-039	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-039	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-039	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-039	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-039	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-040	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-040	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-040	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-040	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-040	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-041	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-041	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-041	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-041	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-041	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-042	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-042	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-042	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-042	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current
65862-042	Lisinopril	Lisinopril	Aurobindo Pharma Limited	ANDA	Current