Application 077626

Type: ANDA
Sponsor: LUPIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RAMIPRIL	RAMIPRIL	CAPSULE;ORAL	1.25MG	No	No
002	RAMIPRIL	RAMIPRIL	CAPSULE;ORAL	2.5MG	No	No
003	RAMIPRIL	RAMIPRIL	CAPSULE;ORAL	5MG	No	No
004	RAMIPRIL	RAMIPRIL	CAPSULE;ORAL	10MG	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
A077626-001	RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09
A077626-002	RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09
A077626-003	RAMIPRIL	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09
A077626-004	RAMIPRIL	RAMIPRIL	10MG	CAPSULE / ORAL	AB	RS	2008-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077626-001	AB
A077626-002	AB
A077626-003	AB
A077626-004	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	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	RS	2008-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	RS	2008-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	RS	2008-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB		2008-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB		2008-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB		2008-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB		2008-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB		2008-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB		2008-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB		2008-06-09	`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	A077626-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077626-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077626-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077626-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077626-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077626-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077626-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077626-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077626-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077626-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077626-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077626-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077626-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077626-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077626-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077626-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077626-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077626-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077626-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077626-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077626-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077626-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077626-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077626-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077626-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077626-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077626-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077626-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077626-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077626-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077626-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077626-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077626-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077626-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077626-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077626-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077626-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077626-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077626-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077626-004	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramipril	RAMIPRIL	Bryant Ranch Prepack	3806abdc-6aec-4252-bd79-e2c115b849aa	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077626 application number: ANDA077626
Ramipril	RAMIPRIL	Lupin Pharmaceuticals, Inc.	a8cdec12-81d1-4ef4-82c0-d05d93c37a07	2026-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077626 application number: ANDA077626 ndc (product): 68180-590 ndc (product): 68180-589 ndc (product): 68180-591 ndc (product): 68180-588
Ramipril	RAMIPRIL	Northwind Health Company, LLC	ab3124b7-deed-8e04-e053-2a95a90a3b85	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077626 application number: ANDA077626 ndc (product): 51655-346
Ramipril	RAMIPRIL	Northwind Health Company, LLC	ab09a67e-18fe-c860-e053-2a95a90a4d03	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077626 application number: ANDA077626 ndc (product): 51655-144
Ramipril	RAMIPRIL	Northwind Health Company, LLC	ab324cb3-2aaa-b57f-e053-2995a90a2055	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077626 application number: ANDA077626 ndc (product): 51655-347
Ramipril	RAMIPRIL	A-S Medication Solutions	5fb23b7d-ed2b-4984-89c8-d0a509b917e1	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077626 application number: ANDA077626 ndc (product): 50090-3059
Ramipril	RAMIPRIL	Proficient Rx LP	01da05d8-e72e-4208-bf92-a5cd929f15ab	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077626 application number: ANDA077626 ndc (product): 63187-073 ndc (product): 63187-277

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43063-303	Ramipril	Ramipril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-502	Ramipril	Ramipril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-3059	Ramipril	Ramipril	A-S Medication Solutions	ANDA	Current
50090-3059	Ramipril	Ramipril	A-S Medication Solutions	ANDA	Current
50090-4597	Ramipril	Ramipril	A-S Medication Solutions	ANDA	Current
50090-4597	Ramipril	Ramipril	A-S Medication Solutions	ANDA	Current
50090-4691	Ramipril	Ramipril	A-S Medication Solutions	ANDA	Current
50090-4691	Ramipril	Ramipril	A-S Medication Solutions	ANDA	Current
51655-144	Ramipril	Ramipril	Northwind Pharmaceuticals	ANDA	Current
51655-144	Ramipril	Ramipril	Northwind Pharmaceuticals	ANDA	Current
51655-346	Ramipril	Ramipril	Northwind Pharmaceuticals	ANDA	Current
51655-346	Ramipril	Ramipril	Northwind Pharmaceuticals	ANDA	Current
51655-347	Ramipril	Ramipril	Northwind Pharmaceuticals	ANDA	Current
51655-347	Ramipril	Ramipril	Northwind Pharmaceuticals	ANDA	Current
55700-551	Ramipril	Ramipril	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-551	Ramipril	Ramipril	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-157	RAMIPRIL	RAMIPRIL	DIRECT RX	ANDA	Current
61919-157	RAMIPRIL	RAMIPRIL	DIRECT RX	ANDA	Current
63187-073	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
63187-073	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
63187-073	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
63187-073	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
63187-277	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
63187-277	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
63187-277	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
63187-277	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
63187-503	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
63187-503	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
63187-503	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
68180-588	Ramipril	Ramipril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-588	Ramipril	Ramipril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-589	Ramipril	Ramipril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-589	Ramipril	Ramipril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-589	Ramipril	Ramipril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-589	Ramipril	Ramipril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-590	Ramipril	Ramipril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-590	Ramipril	Ramipril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-590	Ramipril	Ramipril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-590	Ramipril	Ramipril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-591	Ramipril	Ramipril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-591	Ramipril	Ramipril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-591	Ramipril	Ramipril	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-591	Ramipril	Ramipril	Lupin Pharmaceuticals, Inc.	ANDA	Current
70934-410	Ramipril	Ramipril	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-438	Ramipril	Ramipril	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-496	Ramipril	Ramipril	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44360	ORIG	2008-07-01
31267	ORIG	2008-06-10