Application 076180

Type: ANDA
Sponsor: PRINSTON INC

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

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076180-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076180-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076180-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A076180-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076180-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076180-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076180-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076180-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076180-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076180-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076180-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076180-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076180-001	LISINOPRIL	2.5MG	TABLET / ORAL	AB	2002-07-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076180-002	LISINOPRIL	5MG	TABLET / ORAL	AB	2002-07-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076180-003	LISINOPRIL	10MG	TABLET / ORAL	AB	2002-07-01	`ea99ee380514…`

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	A076180-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076180-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076180-003	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A076180-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076180-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076180-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076180-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076180-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076180-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076180-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076180-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076180-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076180-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076180-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076180-003	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 1 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LISINOPRIL	LISINOPRIL	St. Mary's Medical Park Pharmacy	6051cc96-86e0-bd0b-e053-2a91aa0a5dcf	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	REMEDYREPACK INC.	42f49299-7ae5-4d30-86eb-66b739c0e95d	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180 ndc (product): 70518-1790
LISINOPRIL	LISINOPRIL	St. Mary's Medical Park Pharmacy	6062fd98-7663-f4b5-e053-2a91aa0acbc3	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	Preferred Pharmaceuticals Inc.	7e297133-669e-4780-a966-c777624e5427	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	Preferred Pharmaceuticals Inc.	affd3e43-077e-42e5-a865-c961624bfe93	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180 ndc (product): 68788-6407
LISINOPRIL	LISINOPRIL	Preferred Pharmaceuticals, Inc.	74415f95-74c9-4329-a6af-a0f165bf7887	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180 ndc (product): 68788-6820
LISINOPRIL	LISINOPRIL	Proficient Rx LP	eddec313-910c-4bf1-9095-2153db53bc6e	2026-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 63187-780
LISINOPRIL	LISINOPRIL	Proficient Rx LP	350c6fc9-9774-4d49-9242-19e96944f83b	2026-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 63187-821
LISINOPRIL	LISINOPRIL	Quality Care Products LLC	babb75f0-bccc-44e8-955a-6873344ccc21	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals, Inc.	4f1f76fe-816c-384a-e054-00144ff88e88	2024-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180 ndc (product): 68071-1894
LISINOPRIL	LISINOPRIL	Bryant Ranch Prepack	24f532f2-c41e-4d1d-989e-7a56b60fbdd4	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 71335-0498
LISINOPRIL	LISINOPRIL	Bryant Ranch Prepack	0bf433cb-bf7d-4b41-9518-400646f9aa2a	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 71335-0176
LISINOPRIL	LISINOPRIL	Bryant Ranch Prepack	37aa2542-de44-401b-a6ff-96d2e07914c7	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 71335-0536
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals, Inc.	4aa518e1-d989-1fde-e054-00144ff88e88	2024-07-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180 ndc (product): 68071-3122
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals, Inc.	4aa44af9-1aff-314c-e054-00144ff8d46c	2024-07-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180 ndc (product): 68071-3123
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	5a1c5b04-b78c-c057-e053-2991aa0aa916	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180 ndc (product): 68071-1672
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	9148529f-6278-e507-e053-2995a90aa4cf	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180 ndc (product): 68071-5046
LISINOPRIL	LISINOPRIL	NuCare Pharmaceuticals,Inc.	86e7a336-c416-6fab-e053-2a91aa0a274c	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180 ndc (product): 68071-4858
LISINOPRIL	LISINOPRIL	Proficient Rx LP	e5fbefd1-4077-4e81-a0e3-e09fadc48593	2023-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180 ndc (product): 63187-534
LISINOPRIL	LISINOPRIL	A-S Medication Solutions	b5683ac4-59dc-4772-8bc6-984c698afbeb	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180

NDC Listings For This Application#

NDC listings for this application page 2 of 3 · 163 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63187-534	LISINOPRIL	Lisinopril	Proficient Rx LP	ANDA	Current
63187-534	LISINOPRIL	Lisinopril	Proficient Rx LP	ANDA	Current
63187-780	LISINOPRIL	Lisinopril	Proficient Rx LP	ANDA	Current
63187-780	LISINOPRIL	Lisinopril	Proficient Rx LP	ANDA	Current
63187-821	LISINOPRIL	Lisinopril	Proficient Rx LP	ANDA	Current
63187-821	LISINOPRIL	Lisinopril	Proficient Rx LP	ANDA	Current
63187-821	LISINOPRIL	Lisinopril	Proficient Rx LP	ANDA	Current
63187-821	LISINOPRIL	Lisinopril	Proficient Rx LP	ANDA	Current
63629-6836	LISINOPRIL	Lisinopril	Bryant Ranch Prepack	ANDA	Current
67296-1249	LISINOPRIL	LISINOPRIL	RedPharm Drug, Inc.	ANDA	Current
67296-1249	LISINOPRIL	LISINOPRIL	RedPharm Drug, Inc.	ANDA	Current
67296-1249	LISINOPRIL	LISINOPRIL	RedPharm Drug, Inc.	ANDA	Current
68071-1672	LISINOPRIL	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1672	LISINOPRIL	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1672	LISINOPRIL	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1894	LISINOPRIL	Lisinopril	NuCare Pharmaceuticals, I	ANDA	Current
68071-1894	LISINOPRIL	Lisinopril	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1894	LISINOPRIL	Lisinopril	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3122	LISINOPRIL	Lisinopril	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3122	LISINOPRIL	Lisinopril	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3123	LISINOPRIL	Lisinopril	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3123	LISINOPRIL	Lisinopril	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3123	LISINOPRIL	Lisinopril	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4858	LISINOPRIL	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4858	LISINOPRIL	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5046	LISINOPRIL	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5046	LISINOPRIL	Lisinopril	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6407	LISINOPRIL	Lisinopril	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6407	LISINOPRIL	Lisinopril	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6407	LISINOPRIL	Lisinopril	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6407	LISINOPRIL	Lisinopril	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6407	LISINOPRIL	Lisinopril	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6820	LISINOPRIL	Lisinopril	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6820	LISINOPRIL	Lisinopril	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6820	LISINOPRIL	Lisinopril	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6820	LISINOPRIL	Lisinopril	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6820	LISINOPRIL	Lisinopril	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6898	LISINOPRIL	Lisinopril	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6898	LISINOPRIL	Lisinopril	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6898	LISINOPRIL	Lisinopril	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0117	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-0117	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-0117	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-0117	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-0117	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-0117	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-0117	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-0530	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-0530	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-0530	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-1528	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-1528	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-1528	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-1790	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-1790	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-2600	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-2600	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70518-2600	LISINOPRIL	Lisinopril	REMEDYREPACK INC.	ANDA	Current
70934-120	LISINOPRIL	Lisinopril	Denton Pharma, Inc. DBA N	ANDA	Current
70934-120	LISINOPRIL	Lisinopril	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-120	LISINOPRIL	Lisinopril	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-613	LISINOPRIL	Lisinopril	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-720	LISINOPRIL	Lisinopril	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71335-0176	LISINOPRIL	Lisinopril	Bryant Ranch Prepack	ANDA	Current
71335-0176	LISINOPRIL	Lisinopril	Bryant Ranch Prepack	ANDA	Current
71335-0176	LISINOPRIL	Lisinopril	Bryant Ranch Prepack	ANDA	Current
71335-0176	LISINOPRIL	Lisinopril	Bryant Ranch Prepack	ANDA	Current
71335-0498	LISINOPRIL	Lisinopril	Bryant Ranch Prepack	ANDA	Current
71335-0498	LISINOPRIL	Lisinopril	Bryant Ranch Prepack	ANDA	Current
71335-0498	LISINOPRIL	Lisinopril	Bryant Ranch Prepack	ANDA	Current
71335-0498	LISINOPRIL	Lisinopril	Bryant Ranch Prepack	ANDA	Current
71335-0536	LISINOPRIL	Lisinopril	Bryant Ranch Prepack	ANDA	Current
71335-0536	LISINOPRIL	Lisinopril	Bryant Ranch Prepack	ANDA	Current
71335-0536	LISINOPRIL	Lisinopril	Bryant Ranch Prepack	ANDA	Current
71335-0536	LISINOPRIL	Lisinopril	Bryant Ranch Prepack	ANDA	Current
71335-1295	LISINOPRIL	Lisinopril	Bryant Ranch Prepack	ANDA	Current
71335-1295	LISINOPRIL	Lisinopril	Bryant Ranch Prepack	ANDA	Current
71610-588	LISINOPRIL	Lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-612	LISINOPRIL	Lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-612	LISINOPRIL	Lisinopril	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8873	ORIG	2003-04-11