Dipyridamole

Product NDC: 65841-662
Requested package NDC: 65841-662-01
11-digit product format: 658410662
Labeler code: 65841
Product ID: 65841-662_7426aa35-2cba-4a73-b80f-d044bfe22177
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dipyridamole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA040874
Marketing category: ANDA
Marketing start: 2008-05-22
Substance: DIPYRIDAMOLE
Active strength: 25 mg/1
Pharmacologic classes: Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	A040874-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2008-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040874-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2008-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040874-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2008-01-28	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040874-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040874-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040874-003	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Dipyridamole
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPYRIDAMOLE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
64ALC7F90C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197622	Internal RxNorm lookup
309952	Internal RxNorm lookup
309955	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312aadb1-435c-4aa7-8e46-6506cedacaa0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
3285f096-1048-1647-9b36-a2e0f5b56c6c	Product name	1	20140508
9ab2f788-fb50-9b8e-e14c-49841b1b5968	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65841-662-01	Dipyridamole	100 in 1 BOTTLE	TABLET, FILM COATED	100	8
65841-662-05	Dipyridamole	500 in 1 BOTTLE	TABLET, FILM COATED	500	8
65841-662-10	Dipyridamole	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	8
65841-662-77	Dipyridamole	10 in 1 CARTON	TABLET, FILM COATED	10	8
65841-662-77	Dipyridamole	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPYRIDAMOLE	ACTIVE INGREDIENT	64ALC7F90C	DIPYRIDAMOLE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
DIPYRIDAMOLE	ACTIVE MOIETY	64ALC7F90C	DIPYRIDAMOLE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DIPYRIDAMOLE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIPYRIDAMOLE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIPYRIDAMOLE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIPYRIDAMOLE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	DIPYRIDAMOLE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	DIPYRIDAMOLE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIPYRIDAMOLE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIPYRIDAMOLE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-662	DIPYRIDAMOLE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	8	Current NDC, Legacy NDC, 5 package rows	20241130_312aadb1-435c-4aa7-8e46-6506cedacaa0.zip

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 (package): 65841-662-01 ndc (product): 65841-662 ndc11 (package): 65841066201
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
64ALC7F90C	DIPYRIDAMOLE	58-32-2	DIPYRIDAMOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309952	dipyridamole 25 MG Oral Tablet	PSN	312aadb1-435c-4aa7-8e46-6506cedacaa0	8
197622	dipyridamole 50 MG Oral Tablet	PSN	312aadb1-435c-4aa7-8e46-6506cedacaa0	8
309955	dipyridamole 75 MG Oral Tablet	PSN	312aadb1-435c-4aa7-8e46-6506cedacaa0	8
309952	dipyridamole 25 MG Oral Tablet	SCD	312aadb1-435c-4aa7-8e46-6506cedacaa0	8
197622	dipyridamole 50 MG Oral Tablet	SCD	312aadb1-435c-4aa7-8e46-6506cedacaa0	8
309955	dipyridamole 75 MG Oral Tablet	SCD	312aadb1-435c-4aa7-8e46-6506cedacaa0	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65841-662-01	65841066201	100 TABLET, FILM COATED in 1 BOTTLE (65841-662-01)	2008-05-22	0000-00-00	No	No	Current