Application 076063

Type: ANDA
Sponsor: HIKMA INTL PHARMS

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	Approval date
A076063-001	LISINOPRIL	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01
A076063-002	LISINOPRIL	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01
A076063-003	LISINOPRIL	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01
A076063-004	LISINOPRIL	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01
A076063-005	LISINOPRIL	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01
A076063-006	LISINOPRIL	LISINOPRIL	30MG	TABLET / ORAL	2003-06-27

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	A076063-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076063-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076063-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076063-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076063-005	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076063-006	LISINOPRIL	30MG	TABLET / ORAL	2003-06-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076063-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076063-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076063-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076063-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076063-005	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076063-006	LISINOPRIL	30MG	TABLET / ORAL	2003-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076063-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076063-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076063-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076063-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076063-005	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076063-006	LISINOPRIL	30MG	TABLET / ORAL	2003-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076063-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076063-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076063-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076063-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076063-005	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076063-006	LISINOPRIL	30MG	TABLET / ORAL	2003-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076063-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076063-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076063-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076063-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076063-005	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076063-006	LISINOPRIL	30MG	TABLET / ORAL	2003-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076063-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076063-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076063-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076063-004	LISINOPRIL	20MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076063-005	LISINOPRIL	40MG	TABLET / ORAL	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076063-006	LISINOPRIL	30MG	TABLET / ORAL	2003-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076063-001	LISINOPRIL	2.5MG	TABLET / ORAL	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076063-002	LISINOPRIL	5MG	TABLET / ORAL	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076063-003	LISINOPRIL	10MG	TABLET / ORAL	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076063-004	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
2019-12-13 00:20 UTC	2019-12	A076063-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076063-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076063-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076063-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076063-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076063-006	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076063-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076063-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076063-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076063-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076063-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076063-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076063-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076063-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076063-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076063-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076063-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076063-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076063-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076063-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076063-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076063-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076063-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076063-006	AB	1	`ea99ee380514…`

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 2 of 8 · 156 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril	LISINOPRIL	PD-Rx Pharmaceuticals, Inc.	c621c33b-cb67-4ea6-b2bd-96c20a244ea4	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals, Inc.	4b6dc0d4-4acd-3606-e054-00144ff8d46c	2026-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Coupler LLC	538429b8-4f10-e825-e063-6294a90a5905	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Preferred Pharmaceuticals Inc.	ab561d21-7466-4d8b-8d06-291c1d4d82ff	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Preferred Pharmaceuticals Inc.	7e297133-669e-4780-a966-c777624e5427	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Preferred Pharmaceuticals Inc.	affd3e43-077e-42e5-a865-c961624bfe93	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Preferred Pharmaceuticals Inc.	02c23f9c-f3cf-4366-ae1e-56296f1fedf9	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Preferred Pharmaceuticals, Inc.	74415f95-74c9-4329-a6af-a0f165bf7887	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Cardinal Health 107, LLC	1d0caa63-9ea2-4a97-a23b-900a7c514bc6	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Coupler LLC	518a63e3-8ca1-bbd1-e063-6294a90aa524	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Coupler LLC	509a46cf-7a89-b6c0-e063-6394a90a7509	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Bryant Ranch Prepack	08b0555e-41d2-44c3-b27b-ad5d701378dc	2026-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Bryant Ranch Prepack	59fd2167-4da4-9143-83bd-3b6aa5051511	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	f57bd658-05d8-475a-ae74-87d2c7866417	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	176c744a-d4e3-4a4b-ac62-4fbcb1d8d7bf	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	bd804d65-742a-4890-ac9d-bee69968387d	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
Lisinopril	LISINOPRIL	Legacy Pharmaceutical Packaging, LLC	f5db9549-e179-3db6-e053-2995a90a1544	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	11a83bbc-9871-4df8-b3f2-7aba5149f3fe	2026-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Proficient Rx LP	eddec313-910c-4bf1-9095-2153db53bc6e	2026-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL generic name: LISINOPRIL
LISINOPRIL	LISINOPRIL	Proficient Rx LP	350c6fc9-9774-4d49-9242-19e96944f83b	2026-03-01	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 · 53 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-1266	Lisinopril	Lisinopril	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-1266	Lisinopril	Lisinopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1266	Lisinopril	Lisinopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1267	Lisinopril	Lisinopril	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-1267	Lisinopril	Lisinopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1267	Lisinopril	Lisinopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1268	Lisinopril	Lisinopril	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-1268	Lisinopril	Lisinopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1268	Lisinopril	Lisinopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1270	Lisinopril	Lisinopril	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-1270	Lisinopril	Lisinopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1270	Lisinopril	Lisinopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9713	Lisinopril	Lisinopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9713	Lisinopril	Lisinopril	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9714	Lisinopril	Lisinopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9714	Lisinopril	Lisinopril	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9715	Lisinopril	Lisinopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9715	Lisinopril	Lisinopril	West-Ward Pharmaceuticals Corp	ANDA	Current
50090-0809	Lisinopril	Lisinopril	A-S Medication Solutions	ANDA	Current
50090-1507	Lisinopril	Lisinopril	A-S Medication Solutions	ANDA	Current
50090-1737	Lisinopril	Lisinopril	A-S Medication Solutions	ANDA	Current
50090-2384	Lisinopril	Lisinopril	A-S Medication Solutions	ANDA	Current
50436-2000	Lisinopril	Lisinopril	Unit Dose Services	ANDA	Current
50436-4000	Lisinopril	Lisinopril	Unit Dose Services	ANDA	Current
50436-5000	Lisinopril	Lisinopril	Unit Dose Services	ANDA	Current
50436-8700	Lisinopril	Lisinopril	Unit Dose Services	ANDA	Current
51138-063	Lisinopril	Lisinopril	Med-Health Pharma, LLC	ANDA	Current
51138-064	Lisinopril	Lisinopril	Med-Health Pharma, LLC	ANDA	Current
51138-065	Lisinopril	Lisinopril	Med-Health Pharma, LLC	ANDA	Current
51138-066	Lisinopril	Lisinopril	Med-Health Pharma, LLC	ANDA	Current
51138-067	Lisinopril	Lisinopril	Med-Health Pharma, LLC	ANDA	Current
51138-068	Lisinopril	Lisinopril	Med-Health Pharma, LLC	ANDA	Current
53217-253	Lisinopril	Lisinopril	Aidarex Pharmaceuticals LLC	ANDA	Current
53808-0692	Lisinopril	Lisinopril	State of Florida DOH Central Pharmacy	ANDA	Current
55289-696	Lisinopril	Lisinopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-917	Lisinopril	Lisinopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
59115-144	Lisinopril	Lisinopril	Hikma Pharmaceutical	ANDA	Current
59115-144	Lisinopril	Lisinopril	Hikma Pharmaceutical	ANDA	Current
59115-145	Lisinopril	Lisinopril	Hikma Pharmaceutical	ANDA	Current
59115-145	Lisinopril	Lisinopril	Hikma Pharmaceutical	ANDA	Current
59115-146	Lisinopril	Lisinopril	Hikma Pharmaceutical	ANDA	Current
59115-146	Lisinopril	Lisinopril	Hikma Pharmaceutical	ANDA	Current
59115-147	Lisinopril	Lisinopril	Hikma Pharmaceutical	ANDA	Current
59115-147	Lisinopril	Lisinopril	Hikma Pharmaceutical	ANDA	Current
63629-2935	Lisinopril	Lisinopril	Bryant Ranch Prepack	ANDA	Current
63629-2935	Lisinopril	Lisinopril	Bryant Ranch Prepack	ANDA	Current
63629-7445	Lisinopril	Lisinopril	Bryant Ranch Prepack	ANDA	Current
63629-7445	Lisinopril	Lisinopril	Bryant Ranch Prepack	ANDA	Current
68387-521	Lisinopril	Lisinopril	Keltman Pharmaceuticals Inc.	ANDA	Current
68788-9750	Lisinopril	Lisinopril	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9910	Lisinopril	Lisinopril	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9911	Lisinopril	Lisinopril	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9912	Lisinopril	Lisinopril	Preferred Pharmaceuticals, Inc.	ANDA	Current