Application 077690

Type: ANDA
Sponsor: LUPIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	TABLET;ORAL	EQ 5MG BASE	No	No
002	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	TABLET;ORAL	EQ 10MG BASE	No	No
003	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	TABLET;ORAL	EQ 20MG BASE	No	No
004	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	TABLET;ORAL	EQ 40MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077690-001	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2006-06-20
A077690-002	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2006-06-20
A077690-003	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2006-06-20
A077690-004	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	RS	2006-06-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A077690-001	AB
A077690-002	AB
A077690-003	AB
A077690-004	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077690-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2006-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077690-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2006-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077690-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2006-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077690-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	RS	2006-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077690-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2006-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077690-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2006-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077690-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2006-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077690-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	RS	2006-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077690-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2006-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077690-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2006-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077690-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2006-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077690-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	RS	2006-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077690-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2006-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077690-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2006-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077690-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2006-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077690-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	RS	2006-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077690-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2006-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077690-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2006-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077690-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2006-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077690-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	RS	2006-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077690-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2006-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077690-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2006-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077690-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2006-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077690-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	RS	2006-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077690-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2006-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077690-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2006-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077690-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2006-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077690-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	RS	2006-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077690-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2006-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077690-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2006-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077690-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2006-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077690-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	RS	2006-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077690-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2006-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077690-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2006-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077690-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2006-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077690-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	RS	2006-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077690-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2006-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077690-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2006-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077690-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB		2006-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077690-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	RS	2006-06-20	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077690-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077690-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077690-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077690-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077690-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077690-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077690-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077690-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077690-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077690-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077690-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077690-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077690-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077690-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077690-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077690-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077690-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077690-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077690-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077690-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077690-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077690-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077690-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077690-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077690-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077690-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077690-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077690-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077690-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077690-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077690-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077690-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077690-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077690-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077690-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077690-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077690-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077690-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077690-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077690-004	AB	1	`d06236e962d9…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quinapril	QUINAPRIL	Northwind Health Company, LLC	da562e3b-4411-e750-e053-2a95a90ad7e5	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077690 application number: ANDA077690
Quinapril	QUINAPRIL	Bryant Ranch Prepack	a6cf2ffd-cf94-4f1c-a12e-ce0e93a6304d	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077690 application number: ANDA077690 ndc (product): 71335-1707
Quinapril	QUINAPRIL	Lupin Pharmaceuticals, Inc.	8ded0773-3aec-4e89-9836-d22a5a84abf0	2023-12-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077690 application number: ANDA077690 ndc (product): 68180-558 ndc (product): 68180-554 ndc (product): 68180-557 ndc (product): 68180-556
Quinapril	QUINAPRIL	Proficient Rx LP	2efb2ede-a49b-4e3e-9c93-4c202f67211f	2022-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077690 application number: ANDA077690 ndc (product): 71205-635
Quinapril	QUINAPRIL	BluePoint Laboratories	1b5809a8-873d-44cb-af59-e0d8fc81b385	2020-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077690 application number: ANDA077690 ndc (product): 68001-188 ndc (product): 68001-187 ndc (product): 68001-260 ndc (product): 68001-189

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-393	Quinapril	Quinapril	Rebel Distributors Corp	ANDA	Current
21695-394	Quinapril	Quinapril	Rebel Distributors Corp	ANDA	Current
50090-5165	Quinapril	Quinapril	A-S Medication Solutions	ANDA	Current
50090-5165	Quinapril	Quinapril	A-S Medication Solutions	ANDA	Current
50090-5165	Quinapril	Quinapril	A-S Medication Solutions	ANDA	Current
50090-5487	Quinapril	Quinapril	A-S Medication Solutions	ANDA	Current
50090-5487	Quinapril	Quinapril	A-S Medication Solutions	ANDA	Current
68001-187	Quinapril	Quinapril	BluePoint Laboratories	ANDA	Current
68001-187	Quinapril	Quinapril	BluePoint Laboratories	ANDA	Current
68001-188	Quinapril	Quinapril	BluePoint Laboratories	ANDA	Current
68001-188	Quinapril	Quinapril	BluePoint Laboratories	ANDA	Current
68001-189	Quinapril	Quinapril	BluePoint Laboratories	ANDA	Current
68001-189	Quinapril	Quinapril	BluePoint Laboratories	ANDA	Current
68001-260	Quinapril	Quinapril	BluePoint Laboratories	ANDA	Current
68001-260	Quinapril	Quinapril	BluePoint Laboratories	ANDA	Current
68084-899	Quinapril	Quinapril	American Health Packaging	ANDA	Current
68084-899	Quinapril	Quinapril	American Health Packaging	ANDA	Current
68084-899	Quinapril	Quinapril	American Health Packaging	ANDA	Current
68084-899	Quinapril	Quinapril	American Health Packaging	ANDA	Current
68180-554	Quinapril	Quinapril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-554	Quinapril	Quinapril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-554	Quinapril	Quinapril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-554	Quinapril	Quinapril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-556	Quinapril	Quinapril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-556	Quinapril	Quinapril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-556	Quinapril	Quinapril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-556	Quinapril	Quinapril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-557	Quinapril	Quinapril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-557	Quinapril	Quinapril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-557	Quinapril	Quinapril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-557	Quinapril	Quinapril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-558	Quinapril	Quinapril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-558	Quinapril	Quinapril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-558	Quinapril	Quinapril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-558	Quinapril	Quinapril	Lupin Pharmaceuticals, Inc.	ANDA	Current
70934-582	Quinapril	Quinapril	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-635	Quinapril	Quinapril	Proficient Rx LP	ANDA	Current
71205-635	Quinapril	Quinapril	Proficient Rx LP	ANDA	Current
71335-1441	Quinapril	Quinapril	Bryant Ranch Prepack	ANDA	Current
71335-1441	Quinapril	Quinapril	Bryant Ranch Prepack	ANDA	Current
71335-1707	Quinapril	Quinapril	Bryant Ranch Prepack	ANDA	Current
71335-1707	Quinapril	Quinapril	Bryant Ranch Prepack	ANDA	Current
71335-1707	Quinapril	Quinapril	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23882	ORIG	2006-07-05