CILOSTAZOL

Product NDC: 72189-116
Requested package NDC: 72189-116-60
11-digit product format: 721890116
Labeler code: 72189
Product ID: 72189-116_2be8fd92-0c90-d751-e063-6394a90af165
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CILOSTAZOL
Dosage form: TABLET
Route: ORAL
Labeler: direct rx
Application: ANDA077027
Marketing category: ANDA
Marketing start: 2020-12-02
Substance: CILOSTAZOL
Active strength: 50 mg/1
Pharmacologic classes: Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-116	72189-116-60	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077027-001	CILOSTAZOL	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24
A077027-002	CILOSTAZOL	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077027-001	AB
A077027-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077027-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	RS	2004-11-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077027-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	RS	2004-11-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A077027-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077027-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077027-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077027-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077027-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077027-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077027-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077027-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077027-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077027-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077027-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077027-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077027-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077027-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077027-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077027-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077027-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077027-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077027-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077027-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077027-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077027-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077027-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077027-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077027-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077027-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077027-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077027-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077027-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077027-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077027-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077027-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077027-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077027-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077027-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077027-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077027-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077027-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077027-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077027-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CILOSTAZOL	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N7Z035406B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
242462	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
b57d3c1e-e36f-5255-e053-2a95a90ada83	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c114def4-591e-cde9-1a9f-29af28d4c1ea	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-116-60	CILOSTAZOL	60 in 1 BOTTLE	TABLET	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-116	CILOSTAZOL TABLET [DIRECT RX]	2	Current NDC, Legacy NDC, 1 package rows	20250119_b57d3c1e-e36f-5255-e053-2a95a90ada83.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CILOSTAZOL	CILOSTAZOL	direct rx	b57d3c1e-e36f-5255-e053-2a95a90ada83	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077027 application number: ANDA077027 ndc (package): 72189-116-60 ndc (product): 72189-116 ndc11 (package): 72189011660
Cilostazol	CILOSTAZOL	Bryant Ranch Prepack	f728395c-684c-4087-a389-c323dbcb72dd	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077027 application number: ANDA077027
Cilostazol	CILOSTAZOL	Bryant Ranch Prepack	53486382-eee0-4cbe-bc4a-a57484e0d5a7	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077027 application number: ANDA077027
Cilostazol	CILOSTAZOL	Teva Pharmaceuticals USA, Inc.	a6292311-9cb2-49ff-b8bf-12e2dbd196cd	2022-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077027 application number: ANDA077027

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
242462	cilostazol 50 MG Oral Tablet	PSN	b57d3c1e-e36f-5255-e053-2a95a90ada83	2
242462	cilostazol 50 MG Oral Tablet	SCD	b57d3c1e-e36f-5255-e053-2a95a90ada83	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-116-60	72189011660	60 TABLET in 1 BOTTLE (72189-116-60)	60 tablet	2020-12-02	0000-00-00	No	No	Current