Application 091604

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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	Approval date
A091604-001	RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08
A091604-002	RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08
A091604-003	RAMIPRIL	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08
A091604-004	RAMIPRIL	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091604-001	AB
A091604-002	AB
A091604-003	AB
A091604-004	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`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	A091604-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091604-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091604-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091604-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091604-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091604-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091604-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091604-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091604-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091604-004	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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramipril	RAMIPRIL	Aurobindo Pharma Limited	d6d57158-e8f9-4c91-8317-0374e0c87d33	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	Bryant Ranch Prepack	ef05b44e-4bf7-4afa-a5f6-06efa0d0abc3	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604 ndc (product): 71335-1056
Ramipril	RAMIPRIL	Bryant Ranch Prepack	8be00433-3113-437e-8ab6-721af4d79185	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604 ndc (product): 71335-1057
Ramipril	RAMIPRIL	Bryant Ranch Prepack	d270b634-0d6d-4614-b223-a2af1e238c2f	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604 ndc (product): 71335-0894
Ramipril	RAMIPRIL	REMEDYREPACK INC.	f6c86139-b1f7-4e84-944f-94af883ce4ea	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	REMEDYREPACK INC.	fcf42121-8e85-4eae-82b4-bc029653b462	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	NuCare Pharmaceuticals, Inc.	4bd2d586-6851-4a40-e063-6394a90a0cab	2026-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	REMEDYREPACK INC.	394a49a8-81bb-43ba-8d6a-fa6fa5030587	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604 ndc (product): 70518-3038
Ramipril	RAMIPRIL	A-S Medication Solutions	e8d9a115-71a7-4580-abbd-865e98b5d3f6	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	A-S Medication Solutions	d856fb57-f1a0-49e6-bb2d-b4924af48515	2026-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	A-S Medication Solutions	a3786664-a1b5-4914-99d6-79fb0e330e98	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	Northwind Health Company, LLC	f2b87655-93c3-16a5-e053-2a95a90a593c	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	Northwind Health Company, LLC	f2f325b8-f33d-3b93-e053-2995a90aa660	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	Northwind Health Company, LLC	f7e61b5b-fb5b-ba15-e053-6394a90adc3c	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	Northwind Health Company, LLC	fb0892da-3db7-3202-e053-6394a90ab605	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	Rising Pharma Holdings, Inc.	d5c58fb5-b415-4567-9790-55631705c5cd	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	A-S Medication Solutions	1576188e-efd4-4e14-870e-fd9bd2751c45	2025-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	A-S Medication Solutions	dd3162eb-5f09-47ac-9efd-3ddeee695a25	2025-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	A-S Medication Solutions	4a91b706-c614-4472-92f2-4da5d7bdbf27	2024-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	Bryant Ranch Prepack	245d3580-77c6-4c0f-b324-c8514b792c59	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 95 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-3038	Ramipril	Ramipril	REMEDYREPACK INC.	ANDA	Current
70934-460	Ramipril	Ramipril	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-460	Ramipril	Ramipril	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-691	Ramipril	Ramipril	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-029	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
71205-029	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
71205-080	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
71205-080	Ramipril	Ramipril	Proficient Rx LP	ANDA	Current
71335-0196	Ramipril	Ramipril	Bryant Ranch Prepack	ANDA	Current
71335-0894	Ramipril	Ramipril	Bryant Ranch Prepack	ANDA	Current
71335-0894	Ramipril	Ramipril	Bryant Ranch Prepack	ANDA	Current
71335-1056	Ramipril	Ramipril	Bryant Ranch Prepack	ANDA	Current
71335-1056	Ramipril	Ramipril	Bryant Ranch Prepack	ANDA	Current
71335-1057	Ramipril	Ramipril	Bryant Ranch Prepack	ANDA	Current
71335-1057	Ramipril	Ramipril	Bryant Ranch Prepack	ANDA	Current