Application 040874

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIPYRIDAMOLE	DIPYRIDAMOLE	TABLET;ORAL	25MG	No	No
002	DIPYRIDAMOLE	DIPYRIDAMOLE	TABLET;ORAL	50MG	No	No
003	DIPYRIDAMOLE	DIPYRIDAMOLE	TABLET;ORAL	75MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040874-001	DIPYRIDAMOLE	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2008-01-28
A040874-002	DIPYRIDAMOLE	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2008-01-28
A040874-003	DIPYRIDAMOLE	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2008-01-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040874-001	AB
A040874-002	AB
A040874-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A040874-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2008-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040874-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2008-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040874-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2008-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040874-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2008-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040874-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2008-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040874-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2008-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040874-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2008-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040874-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2008-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040874-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2008-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040874-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2008-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040874-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2008-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040874-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2008-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040874-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2008-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040874-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2008-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040874-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2008-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040874-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2008-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040874-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2008-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040874-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2008-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040874-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2008-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040874-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2008-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040874-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2008-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040874-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2008-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040874-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2008-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040874-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2008-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040874-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2008-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040874-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2008-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040874-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2008-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040874-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2008-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040874-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2008-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040874-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2008-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040874-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2008-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040874-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2008-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040874-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2008-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040874-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2008-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040874-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2008-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040874-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2008-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040874-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2008-01-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040874-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2008-01-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040874-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2008-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040874-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2008-01-28	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040874-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040874-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040874-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040874-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040874-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040874-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040874-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040874-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040874-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040874-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040874-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040874-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040874-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040874-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040874-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040874-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040874-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040874-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040874-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040874-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040874-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040874-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040874-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040874-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040874-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040874-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040874-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040874-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040874-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040874-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040874-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040874-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040874-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040874-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040874-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040874-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040874-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040874-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040874-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040874-001	AB	1	`1e350fbaab3a…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dipyridamole	DIPYRIDAMOLE	REMEDYREPACK INC.	226099e2-70bb-4b9b-bb52-c20fbca2aec5	2026-04-29	Adverse reactions	Exact identifier application applno (ANDA): 040874 application number: ANDA040874
Dipyridamole	DIPYRIDAMOLE	Zydus Lifesciences Limited	312aadb1-435c-4aa7-8e46-6506cedacaa0	2024-11-26		Exact identifier application applno (ANDA): 040874 application number: ANDA040874 ndc (product): 65841-662 ndc (product): 65841-663 ndc (product): 65841-664
Dipyridamole	DIPYRIDAMOLE	Zydus Pharmaceuticals USA Inc.	004bada0-dbf7-4a94-8792-6833d7eeda2b	2023-09-16	Adverse reactions	Exact identifier application applno (ANDA): 040874 application number: ANDA040874 ndc (product): 68382-188 ndc (product): 68382-187 ndc (product): 68382-189

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65841-662	Dipyridamole	Dipyridamole	Zydus Lifesciences Limited	ANDA	Current
65841-662	Dipyridamole	Dipyridamole	Cadila Healthcare Limited	ANDA	Current
65841-662	Dipyridamole	Dipyridamole	Cadila Healthcare Limited	ANDA	Current
65841-662	Dipyridamole	Dipyridamole	Cadila Healthcare Limited	ANDA	Current
65841-663	Dipyridamole	Dipyridamole	Zydus Lifesciences Limited	ANDA	Current
65841-663	Dipyridamole	Dipyridamole	Cadila Healthcare Limited	ANDA	Current
65841-663	Dipyridamole	Dipyridamole	Cadila Healthcare Limited	ANDA	Current
65841-663	Dipyridamole	Dipyridamole	Cadila Healthcare Limited	ANDA	Current
65841-664	Dipyridamole	Dipyridamole	Zydus Lifesciences Limited	ANDA	Current
65841-664	Dipyridamole	Dipyridamole	Cadila Healthcare Limited	ANDA	Current
65841-664	Dipyridamole	Dipyridamole	Cadila Healthcare Limited	ANDA	Current
65841-664	Dipyridamole	Dipyridamole	Cadila Healthcare Limited	ANDA	Current
68382-187	Dipyridamole	Dipyridamole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-187	Dipyridamole	Dipyridamole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-187	Dipyridamole	Dipyridamole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-187	Dipyridamole	Dipyridamole	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-188	Dipyridamole	Dipyridamole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-188	Dipyridamole	Dipyridamole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-188	Dipyridamole	Dipyridamole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-188	Dipyridamole	Dipyridamole	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-189	Dipyridamole	Dipyridamole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-189	Dipyridamole	Dipyridamole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-189	Dipyridamole	Dipyridamole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-189	Dipyridamole	Dipyridamole	Zydus Pharmaceuticals USA Inc.	ANDA	Current