Home NDC 42291-453 cilostazol
Product NDC 42291-453
11-digit product format 422910453
Labeler code 42291
Product ID 42291-453_485d4436-cc9f-8ea9-e063-6294a90a53be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cilostazol
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA077030
Marketing category ANDA
Marketing start 2022-04-12
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.
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 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.
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 242461 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-453-60 cilostazol 60 in 1 BOTTLE TABLET 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-453 CILOSTAZOL TABLET [AVKARE] 2 Current NDC, Legacy NDC, 1 package rows 20240110_dc7c2c25-36a1-e3fd-e053-2995a90adabc.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 ndc (product): 42291-453 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 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-453-60 42291045360 60 TABLET in 1 BOTTLE (42291-453-60) 60 tablet 2022-04-12 0000-00-00 No No Current