Home NDC 0185-0223-05 Cilostazol
Product NDC 0185-0223
Requested package NDC 0185-0223-05
11-digit product format 001850223
Labeler code 0185
Product ID 0185-0223_05a33095-18cb-4628-811d-ba56f7e07820
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cilostazol
Dosage form TABLET
Route ORAL
Labeler Eon Labs, Inc.
Application ANDA077021
Marketing category ANDA
Marketing start 2004-11-23
Marketing end 2022-07-31
Substance CILOSTAZOL
Active strength 100 mg/1
Pharmacologic classes Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CILOSTAZOL ACTIVE INGREDIENT N7Z035406B CILOSTAZOL TABLET [EON LABS, INC.] 18 CILOSTAZOL ACTIVE MOIETY N7Z035406B CILOSTAZOL TABLET [EON LABS, INC.] 18 CARBOXYMETHYLCELLULOSE CALCIUM INACTIVE INGREDIENT UTY7PDF93L CILOSTAZOL TABLET [EON LABS, INC.] 18 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CILOSTAZOL TABLET [EON LABS, INC.] 18 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CILOSTAZOL TABLET [EON LABS, INC.] 18 METHYLCELLULOSE (15 MPA.S) INACTIVE INGREDIENT NPU9M2E6L8 CILOSTAZOL TABLET [EON LABS, INC.] 18 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CILOSTAZOL TABLET [EON LABS, INC.] 18
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cilostazol CILOSTAZOL Chartwell RX, LLC 77e77eaf-5556-43ac-844e-c0e29f02fe07 2025-09-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077021 application number: ANDA077021
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0185-0223-05 00185022305 500 TABLET in 1 BOTTLE (0185-0223-05) 500 tablet 2004-11-23 2022-07-31 No No Current