Home NDC 60505-2522 cilostazol
Product NDC 60505-2522
11-digit product format 605052522
Labeler code 60505
Product ID 60505-2522_855689c6-1a9b-a366-dcc4-e6a1c04ff25a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cilostazol
Dosage form TABLET
Route ORAL
Labeler Apotex Corp.
Application ANDA077030
Marketing category ANDA
Marketing start 2011-10-18
Substance CILOSTAZOL
Active strength 100 mg/1
Pharmacologic classes Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 2026-12-31 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-2522-1 cilostazol 60 in 1 BOTTLE TABLET 60 10 60505-2522-3 cilostazol 30 in 1 BOTTLE TABLET 30 10 60505-2522-8 cilostazol 1000 in 1 BOTTLE TABLET 1000 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-2522 CILOSTAZOL TABLET [APOTEX CORP.] 9 Current NDC, Legacy NDC, 3 package rows 20240922_ceac1ae3-c343-28ca-c083-b748d21a15e6.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 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 ndc (product): 60505-2522 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 60505-2522-1 60505252201 60 TABLET in 1 BOTTLE (60505-2522-1) 60 tablet 2011-10-18 0000-00-00 No No Current 60505-2522-3 60505252203 30 TABLET in 1 BOTTLE (60505-2522-3) 30 tablet 2011-10-18 0000-00-00 No No Current 60505-2522-8 60505252208 1000 TABLET in 1 BOTTLE (60505-2522-8) 1000 tablet 2011-10-18 0000-00-00 No No Current