Application 075944

Type: ANDA
Sponsor: SUN PHARM INDS LTD

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	40MG	No	No
006	LISINOPRIL	LISINOPRIL	TABLET;ORAL	30MG	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
A075944-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01
A075944-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01
A075944-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01
A075944-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01
A075944-005	LISINOPRIL	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01
A075944-006	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	AB	2003-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075944-001	AB
A075944-002	AB
A075944-003	AB
A075944-004	AB
A075944-005	AB
A075944-006	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	A075944-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075944-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075944-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075944-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075944-005	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075944-006	LISINOPRIL	30MG	TABLET / ORAL	AB	2003-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075944-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075944-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075944-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075944-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075944-005	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075944-006	LISINOPRIL	30MG	TABLET / ORAL	AB	2003-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075944-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075944-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075944-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075944-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075944-005	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075944-006	LISINOPRIL	30MG	TABLET / ORAL	AB	2003-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075944-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075944-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075944-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075944-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075944-005	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075944-006	LISINOPRIL	30MG	TABLET / ORAL	AB	2003-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075944-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075944-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075944-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075944-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075944-005	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075944-006	LISINOPRIL	30MG	TABLET / ORAL	AB	2003-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075944-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075944-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075944-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075944-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075944-005	LISINOPRIL	40MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075944-006	LISINOPRIL	30MG	TABLET / ORAL	AB	2003-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075944-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075944-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075944-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075944-004	LISINOPRIL	20MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 5 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-14 00:12 UTC	2019-12	A075944-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075944-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075944-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075944-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075944-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075944-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075944-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075944-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075944-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075944-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075944-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075944-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075944-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075944-006	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075944-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075944-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075944-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075944-004	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075944-005	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075944-006	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075944-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075944-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075944-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075944-004	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075944-005	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075944-006	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075944-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075944-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075944-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075944-004	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075944-005	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075944-006	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075944-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075944-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075944-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075944-004	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075944-005	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075944-006	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075944-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075944-002	AB	1	`9b2671bbb829…`

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 8 · 156 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	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	463308ef-16cb-41d8-8d29-6aae2c5a7b0f	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	34bb4602-ccff-4939-91b9-26a63bfd40f7	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Aurobindo Pharma Limited	0e6364a4-6d66-4151-8197-d45e2a762895	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	St. Mary's Medical Park Pharmacy	6051cc96-86e0-bd0b-e053-2a91aa0a5dcf	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	a33d860a-1e17-45b7-aede-51ab3223bebd	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	REMEDYREPACK INC.	42f49299-7ae5-4d30-86eb-66b739c0e95d	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	REMEDYREPACK INC.	12d6fe7e-b5a2-4d49-9a06-a6150234d061	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Coupler LLC	560513ef-4d2c-8ca0-e063-6394a90a674a	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
Lisinopril	LISINOPRIL	A-S Medication Solutions	88b5a2c0-6ad2-48e7-9ffe-715d9159f389	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	A-S Medication Solutions	34953f77-bae1-41fe-af11-3ea0b3ceaa11	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	3451292b-7867-4dc2-afaa-da66b4016017	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	REMEDYREPACK INC.	d32923fe-a323-43c6-af46-bcba7274b0bf	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	REMEDYREPACK INC.	e17bcc2e-f5ed-4846-95d3-a5479c7fee8d	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	St. Mary's Medical Park Pharmacy	6062fd98-7663-f4b5-e053-2a91aa0acbc3	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	St. Mary's Medical Park Pharmacy	5f4c1a62-fb84-8cdc-e053-2a91aa0a671a	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Unit Dose Solutions, Inc.	551665a0-9a92-55df-e063-6394a90a1e2e	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Unit Dose Solutions, Inc.	55189717-f5db-9c63-e063-6294a90a6bc9	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Unit Dose Solutions, Inc.	55191baa-f812-2e71-e063-6294a90a8edf	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	St. Mary's Medical Park Pharmacy	5eff766f-82e2-4cd6-e053-2a91aa0a4782	2026-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43063-138	Lisinopril	Lisinopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
53808-0701	Lisinopril	Lisinopril	State of Florida DOH Central Pharmacy	ANDA	Current
63304-531	Lisinopril	Lisinopril	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-532	Lisinopril	Lisinopril	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-533	Lisinopril	Lisinopril	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-534	Lisinopril	Lisinopril	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-535	Lisinopril	Lisinopril	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-599	Lisinopril	Lisinopril	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
67046-426	Lisinopril	Lisinopril	Contract Pharmacy Services-PA	ANDA	Current
67046-428	Lisinopril	Lisinopril	Contract Pharmacy Services-PA	ANDA	Current
67296-0542	Lisinopril	Lisinopril	RedPharm Drug Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8841	ORIG	2004-06-24