Home NDC 62135-986 Cilostazol
Product NDC 62135-986
11-digit product format 621350986
Labeler code 62135
Product ID 62135-986_3dfa32ae-94ba-4885-e063-6394a90a9333
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cilostazol
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA077021
Marketing category ANDA
Marketing start 2004-11-23
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 · 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 RLD / RS 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# 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 62135-986-60 Cilostazol 60 in 1 BOTTLE TABLET 60 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62135-986-60 62135098660 60 TABLET in 1 BOTTLE (62135-986-60) 60 tablet 2025-08-27 No No Current