Cilostazol

Product NDC: 71610-037
11-digit product format: 716100037
Labeler code: 71610
Product ID: 71610-037_64560280-1d4e-47ff-a839-3a3bef49e760
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cilostazol
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA077021
Marketing category: ANDA
Marketing start: 2004-11-23
Marketing end: 0000-00-00
Substance: CILOSTAZOL
Active strength: 100 mg/1
Pharmacologic classes: Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	71610-037		D	Discontinued by firm	2026-08-03
excluded package	package	71610-037	71610-037-53	D	Discontinued by firm	2026-08-03
excluded package	package	71610-037	71610-037-60	D	Discontinued by firm	2026-08-03
excluded package	package	71610-037	71610-037-80	D	Discontinued by firm	2026-08-03

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 · 8 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	71610-037-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-037-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-037-80	`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	71610-037-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-037-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-037-80	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077021-001	CILOSTAZOL	CILOSTAZOL	100MG	TABLET / ORAL			2004-11-23

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 2 · 41 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	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL		2004-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL		2004-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL		2004-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL		2004-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL		2004-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL		2004-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL		2004-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL		2004-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL		2004-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL		2004-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL		2004-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL		2004-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL		2004-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL		2004-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL		2004-11-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL		2004-11-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL		2004-11-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077021-001	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-11-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077021-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077021-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077021-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077021-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077021-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077021-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077021-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077021-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077021-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077021-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077021-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077021-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077021-001	AB	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077021-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077021-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077021-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077021-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077021-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077021-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077021-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077021-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077021-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077021-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-037-53	EA - Each	71610-037	07673e75-a250-4ac6-9c23-15af025c273d	1	2018-04-19
71610-037-60	EA - Each	71610-037	1f5838f4-149e-410a-bf39-47221fd62614	1	2018-04-19
71610-037-80	EA - Each	71610-037	b3f3b2a4-9848-4a0d-83cd-bdcc91b019af	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-037	CILOSTAZOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20180222_55ae41fb-6c59-4f41-bdc6-db7f75e98e00.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cilostazol	CILOSTAZOL	Chartwell RX, LLC	77e77eaf-5556-43ac-844e-c0e29f02fe07	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077021 application number: ANDA077021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N7Z035406B	CILOSTAZOL	73963-72-1	CILOSTAZOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-037-53	71610003753	60 TABLET in 1 BOTTLE (71610-037-53)	60 tablet	2018-02-02	0000-00-00	No	No	Current
71610-037-60	71610003760	90 TABLET in 1 BOTTLE (71610-037-60)	90 tablet	2018-02-02	0000-00-00	No	No	Current
71610-037-80	71610003780	180 TABLET in 1 BOTTLE (71610-037-80)	180 tablet	2018-02-02	0000-00-00	No	No	Current