cilostazol

Product NDC: 50268-177
11-digit product format: 502680177
Labeler code: 50268
Product ID: 50268-177_47bc4cad-6c05-e6d6-e063-6294a90a5c2d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cilostazol
Dosage form: TABLET
Route: ORAL
Labeler: AvPAK
Application: ANDA077030
Marketing category: ANDA
Marketing start: 2016-10-18
Substance: CILOSTAZOL
Active strength: 100 mg/1
Pharmacologic classes: Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A077030-001	CILOSTAZOL	CILOSTAZOL	50MG	TABLET / ORAL	AB		2004-12-10
A077030-002	CILOSTAZOL	CILOSTAZOL	100MG	TABLET / ORAL	AB		2004-12-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077030-001	AB
A077030-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077030-001	CILOSTAZOL	50MG	TABLET / ORAL	AB	2004-12-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077030-002	CILOSTAZOL	100MG	TABLET / ORAL	AB	2004-12-10	`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	A077030-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077030-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077030-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077030-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077030-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077030-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077030-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077030-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077030-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077030-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077030-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077030-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077030-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077030-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077030-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077030-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077030-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077030-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077030-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077030-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077030-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077030-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077030-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077030-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077030-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077030-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077030-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077030-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077030-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077030-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077030-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077030-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077030-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077030-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077030-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077030-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077030-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077030-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077030-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077030-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: cilostazol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CILOSTAZOL	100 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
242461	Internal RxNorm lookup
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
aec462c8-e225-f520-cae5-80049151c0ff	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
50268-177-11	cilostazol	1 in 1 BLISTER PACK	TABLET	1		8
50268-177-15	cilostazol	50 in 1 BOX, UNIT-DOSE	TABLET	50		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-177-11	EA - Each	50268-177	96989dc7-6902-40ba-a92d-e42b1a91f3f9	1	2016-12-07
50268-177-15	EA - Each	50268-177	acbffe0c-1c5a-4c63-ada5-9dcf857e750b	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-177	CILOSTAZOL TABLET [AVPAK]	7	Current NDC, Legacy NDC, 2 package rows	20240110_aec462c8-e225-f520-cae5-80049151c0ff.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cilostazol	CILOSTAZOL	AvKARE	dc7c2c25-36a1-e3fd-e053-2995a90adabc	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077030 application number: ANDA077030
cilostazol	CILOSTAZOL	AvPAK	aec462c8-e225-f520-cae5-80049151c0ff	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077030 application number: ANDA077030 ndc (product): 50268-177
cilostazol	CILOSTAZOL	Apotex Corp.	ceac1ae3-c343-28ca-c083-b748d21a15e6	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077030 application number: ANDA077030
cilostazol	CILOSTAZOL	Aphena Pharma Solutions - Tennessee, LLC	15ead884-bd4f-7f4b-e063-6394a90a8f81	2024-04-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077030 application number: ANDA077030
cilostazol	CILOSTAZOL	Aphena Pharma Solutions - Tennessee, LLC	15478d90-312f-014e-e063-6294a90ae838	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077030 application number: ANDA077030

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
242461	cilostazol 100 MG Oral Tablet	PSN	aec462c8-e225-f520-cae5-80049151c0ff	8
242462	cilostazol 50 MG Oral Tablet	PSN	aec462c8-e225-f520-cae5-80049151c0ff	8
242461	cilostazol 100 MG Oral Tablet	SCD	aec462c8-e225-f520-cae5-80049151c0ff	8
242462	cilostazol 50 MG Oral Tablet	SCD	aec462c8-e225-f520-cae5-80049151c0ff	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-177-11	50268017711	1 in 1 BLISTER PACK						Historical
50268-177-15	50268017715	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-177-15) / 1 TABLET in 1 BLISTER PACK (50268-177-11)	50 blister pack	2016-10-18	0000-00-00	No	No	Current