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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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
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 (product): 50090-4885
LISINOPRIL	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	2dbec080-a266-4317-8d4b-b4046206416e	2022-02-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180
LISINOPRIL	LISINOPRIL	Aphena Pharma Solutions - Tennessee, LLC	6ba2c7d6-bc9e-4d8b-8d1e-c14004750693	2021-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076180 application number: ANDA076180

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 3 · 163 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8061	Lisinopril	Lisinopril	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8061	Lisinopril	Lisinopril	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8062	LISINOPRIL	Lisinopril	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8062	LISINOPRIL	Lisinopril	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8063	Lisinopril	Lisinopril	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8063	Lisinopril	Lisinopril	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
42708-094	LISINOPRIL	Lisinopril	QPharma Inc	ANDA	Current
42708-094	LISINOPRIL	Lisinopril	QPharma Inc	ANDA	Current
42708-094	LISINOPRIL	Lisinopril	QPharma Inc	ANDA	Current
43063-074	LISINOPRIL	Lisinopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-074	LISINOPRIL	Lisinopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-074	LISINOPRIL	Lisinopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-074	LISINOPRIL	Lisinopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-074	LISINOPRIL	Lisinopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-769	LISINOPRIL	Lisinopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-769	LISINOPRIL	Lisinopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-769	LISINOPRIL	Lisinopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-769	LISINOPRIL	Lisinopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-769	LISINOPRIL	Lisinopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-769	LISINOPRIL	Lisinopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-769	LISINOPRIL	Lisinopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43547-351	LISINOPRIL	Lisinopril	Solco healthcare U.S., LLC	ANDA	Current
43547-351	LISINOPRIL	Lisinopril	Solco healthcare U.S., LLC	ANDA	Current
43547-351	LISINOPRIL	Lisinopril	Solco healthcare U.S., LLC	ANDA	Current
43547-351	LISINOPRIL	Lisinopril	Solco healthcare U.S., LLC	ANDA	Current
43547-352	LISINOPRIL	Lisinopril	Solco healthcare U.S., LLC	ANDA	Current
43547-352	LISINOPRIL	Lisinopril	Solco healthcare U.S., LLC	ANDA	Current
43547-352	LISINOPRIL	Lisinopril	Solco healthcare U.S., LLC	ANDA	Current
43547-352	LISINOPRIL	Lisinopril	Solco healthcare U.S., LLC	ANDA	Current
43547-353	LISINOPRIL	Lisinopril	Solco healthcare U.S., LLC	ANDA	Current
43547-353	LISINOPRIL	Lisinopril	Solco healthcare U.S., LLC	ANDA	Current
43547-353	LISINOPRIL	Lisinopril	Solco healthcare U.S., LLC	ANDA	Current
43547-353	LISINOPRIL	Lisinopril	Solco healthcare U.S., LLC	ANDA	Current
50090-2431	LISINOPRIL	Lisinopril	A-S Medication Solutions	ANDA	Current
50090-2431	LISINOPRIL	Lisinopril	A-S Medication Solutions	ANDA	Current
50090-2431	LISINOPRIL	Lisinopril	A-S Medication Solutions	ANDA	Current
50090-2431	LISINOPRIL	Lisinopril	A-S Medication Solutions	ANDA	Current
50090-3765	LISINOPRIL	Lisinopril	A-S Medication Solutions	ANDA	Current
50090-3765	LISINOPRIL	Lisinopril	A-S Medication Solutions	ANDA	Current
50090-3765	LISINOPRIL	Lisinopril	A-S Medication Solutions	ANDA	Current
50090-3765	LISINOPRIL	Lisinopril	A-S Medication Solutions	ANDA	Current
50090-3765	LISINOPRIL	Lisinopril	A-S Medication Solutions	ANDA	Current
50090-3774	LISINOPRIL	Lisinopril	A-S Medication Solutions	ANDA	Current
50090-3774	LISINOPRIL	Lisinopril	A-S Medication Solutions	ANDA	Current
50090-3774	LISINOPRIL	Lisinopril	A-S Medication Solutions	ANDA	Current
50090-3774	LISINOPRIL	Lisinopril	A-S Medication Solutions	ANDA	Current
50090-4885	LISINOPRIL	Lisinopril	A-S Medication Solutions	ANDA	Current
50090-4885	LISINOPRIL	Lisinopril	A-S Medication Solutions	ANDA	Current
50436-0352	LISINOPRIL	Lisinopril	Unit Dose Services	ANDA	Current
50436-0352	LISINOPRIL	Lisinopril	Unit Dose Services	ANDA	Current
50436-0352	LISINOPRIL	Lisinopril	Unit Dose Services	ANDA	Current
50436-0352	LISINOPRIL	Lisinopril	Unit Dose Services	ANDA	Current
50436-0353	LISINOPRIL	Lisinopril	Unit Dose Services	ANDA	Current
50436-0353	LISINOPRIL	Lisinopril	Unit Dose Services	ANDA	Current
50436-0353	LISINOPRIL	Lisinopril	Unit Dose Services	ANDA	Current
51655-399	LISINOPRIL	Lisinopril	Northwind Pharmaceuticals	ANDA	Current
51655-399	LISINOPRIL	Lisinopril	Northwind Pharmaceuticals	ANDA	Current
51655-399	LISINOPRIL	Lisinopril	Northwind Pharmaceuticals	ANDA	Current
52959-854	LISINOPRIL	LISINOPRIL	H. J. Harkins Company Inc.	ANDA	Current
53002-1123	LISINOPRIL	Lisinopril	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1123	LISINOPRIL	Lisinopril	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1225	LISINOPRIL	Lisinopril	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1225	LISINOPRIL	Lisinopril	RPK Pharmaceuticals, Inc.	ANDA	Current
53217-202	LISINOPRIL	Lisinopril	Aidarex Pharmaceuticals LLC	ANDA	Current
53217-303	LISINOPRIL	Lisinopril	Aidarex Pharmaceuticals LLC	ANDA	Current
55700-479	LISINOPRIL	Lisinopril	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-479	LISINOPRIL	Lisinopril	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-479	LISINOPRIL	Lisinopril	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-479	LISINOPRIL	Lisinopril	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-479	LISINOPRIL	Lisinopril	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-479	LISINOPRIL	Lisinopril	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60760-357	LISINOPRIL	Lisinopril	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-358	LISINOPRIL	Lisinopril	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-717	Lisinopril	Lisinopril	Direct_Rx	ANDA	Current
61919-746	LISINOPRIL	LISINOPRIL	Direct_Rx	ANDA	Current
61919-746	LISINOPRIL	LISINOPRIL	Direct_Rx	ANDA	Current
61919-746	LISINOPRIL	LISINOPRIL	Direct_Rx	ANDA	Current
61919-909	LISINOPRIL	LISINOPRIL	Direct_Rx	ANDA	Current
61919-909	LISINOPRIL	LISINOPRIL	Direct_Rx	ANDA	Current
61919-909	LISINOPRIL	LISINOPRIL	Direct_Rx	ANDA	Current

Documents#

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