Dipyridamole

Product NDC: 0527-1461
11-digit product format: 005271461
Labeler code: 0527
Product ID: 0527-1461_c8c9bc23-afe1-4cde-aed0-64f3d21b94f8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dipyridamole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA040898
Marketing category: ANDA
Marketing start: 2008-04-23
Marketing end: 0000-00-00
Substance: DIPYRIDAMOLE
Active strength: 25 mg/1
Pharmacologic classes: Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0527-1461		D	Discontinued by firm	2026-08-17
excluded package	package	0527-1461	0527-1461-01	D	Discontinued by firm	2026-08-17
excluded package	package	0527-1461	0527-1461-05	D	Discontinued by firm	2026-08-17
excluded package	package	0527-1461	0527-1461-10	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0527-1461-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0527-1461-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0527-1461-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0527-1461-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0527-1461-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0527-1461-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0527-1461-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0527-1461-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0527-1461-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0527-1461-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0527-1461-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0527-1461-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0527-1461-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0527-1461-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0527-1461-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0527-1461-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0527-1461-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0527-1461-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0527-1461-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0527-1461-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0527-1461-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0527-1461-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0527-1461-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0527-1461-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0527-1461-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0527-1461-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0527-1461-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0527-1461-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0527-1461-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0527-1461-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0527-1461-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0527-1461-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0527-1461-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0527-1461-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0527-1461-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0527-1461-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A040898-001	DIPYRIDAMOLE	DIPYRIDAMOLE	25MG	TABLET / ORAL	2008-04-23
A040898-002	DIPYRIDAMOLE	DIPYRIDAMOLE	50MG	TABLET / ORAL	2008-04-23
A040898-003	DIPYRIDAMOLE	DIPYRIDAMOLE	75MG	TABLET / ORAL	2008-04-23

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040898-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	2008-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040898-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	2008-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040898-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	2008-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040898-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	2008-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040898-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	2008-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040898-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	2008-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040898-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	2008-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040898-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	2008-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040898-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	2008-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040898-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	2008-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040898-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	2008-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040898-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	2008-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040898-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	2008-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040898-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	2008-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040898-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	2008-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040898-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	2008-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040898-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	2008-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040898-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	2008-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040898-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	2008-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040898-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	2008-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040898-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	2008-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040898-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	2008-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040898-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	2008-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040898-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	2008-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040898-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	2008-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040898-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	2008-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040898-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	2008-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040898-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	2008-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040898-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	2008-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040898-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	2008-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040898-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	2008-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040898-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	2008-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040898-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	2008-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040898-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	2008-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040898-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	2008-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040898-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	2008-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040898-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	2008-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040898-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	2008-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040898-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	2008-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040898-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	2008-04-23	`1e350fbaab3a…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0527-1461-01	2024-01-30	C162847	48780-1	1030e365-62df-111a-e063-dadaa90a10e2	DIPYRIDAMOLE TABLETS, USP 25 mg, 50 mg, and 75 mg
0527-1461-05	2024-01-30	C162847	48780-1	1030e365-62df-111a-e063-dadaa90a10e2	DIPYRIDAMOLE TABLETS, USP 25 mg, 50 mg, and 75 mg
0527-1461-10	2024-01-30	C162847	48780-1	1030e365-62df-111a-e063-dadaa90a10e2	DIPYRIDAMOLE TABLETS, USP 25 mg, 50 mg, and 75 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-1461-01	EA - Each	0527-1461	c58228a1-dca5-4f8d-8bd7-d3d97f3aa1f5	1	2012-07-24
0527-1461-10	EA - Each	0527-1461	41e3ccb4-b595-4f42-a1d6-171181e30bf6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPYRIDAMOLE	ACTIVE INGREDIENT	64ALC7F90C	DIPYRIDAMOLE TABLET, FILM COATED [LANNETT COMPANY, INC.]	4
DIPYRIDAMOLE	ACTIVE MOIETY	64ALC7F90C	DIPYRIDAMOLE TABLET, FILM COATED [LANNETT COMPANY, INC.]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DIPYRIDAMOLE TABLET, FILM COATED [LANNETT COMPANY, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIPYRIDAMOLE TABLET, FILM COATED [LANNETT COMPANY, INC.]	4
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIPYRIDAMOLE TABLET, FILM COATED [LANNETT COMPANY, INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DIPYRIDAMOLE TABLET, FILM COATED [LANNETT COMPANY, INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIPYRIDAMOLE TABLET, FILM COATED [LANNETT COMPANY, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DIPYRIDAMOLE TABLET, FILM COATED [LANNETT COMPANY, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIPYRIDAMOLE TABLET, FILM COATED [LANNETT COMPANY, INC.]	4
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	DIPYRIDAMOLE TABLET, FILM COATED [LANNETT COMPANY, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIPYRIDAMOLE TABLET, FILM COATED [LANNETT COMPANY, INC.]	4
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	DIPYRIDAMOLE TABLET, FILM COATED [LANNETT COMPANY, INC.]	4
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	DIPYRIDAMOLE TABLET, FILM COATED [LANNETT COMPANY, INC.]	4
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	DIPYRIDAMOLE TABLET, FILM COATED [LANNETT COMPANY, INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIPYRIDAMOLE TABLET, FILM COATED [LANNETT COMPANY, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIPYRIDAMOLE TABLET, FILM COATED [LANNETT COMPANY, INC.]	4

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-1461-01	00527146101	100 TABLET, FILM COATED in 1 BOTTLE (0527-1461-01)	2008-04-23	0000-00-00	No	No	Current
0527-1461-05	00527146105	500 TABLET, FILM COATED in 1 BOTTLE (0527-1461-05)	2008-04-23	0000-00-00	No	No	Current
0527-1461-10	00527146110	1000 TABLET, FILM COATED in 1 BOTTLE (0527-1461-10)	2008-04-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIPYRIDAMOLE TABLETS, USP 25 mg, 50 mg, and 75 mg	Lannett Company, Inc.	2010-11-24	HUMAN PRESCRIPTION DRUG LABEL	8