Home NDC 0054-0044 Cilostazol
Product NDC 0054-0044
11-digit product format 000540044
Labeler code 0054
Product ID 0054-0044_d872300b-ff60-4709-a667-aab53462bfac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cilostazol
Dosage form TABLET
Route ORAL
Labeler West-Ward Pharmaceuticals Corp.
Application ANDA077024
Marketing category ANDA
Marketing start 2005-05-17
Marketing end 0000-00-00
Substance CILOSTAZOL
Active strength 100 mg/1
Pharmacologic classes Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A077024-001 CILOSTAZOL CILOSTAZOL 50MG TABLET / ORAL 2005-05-17 A077024-002 CILOSTAZOL CILOSTAZOL 100MG TABLET / ORAL 2005-05-17
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 A077024-001 CILOSTAZOL 50MG TABLET / ORAL 2005-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077024-002 CILOSTAZOL 100MG TABLET / ORAL 2005-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077024-001 CILOSTAZOL 50MG TABLET / ORAL 2005-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077024-002 CILOSTAZOL 100MG TABLET / ORAL 2005-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077024-001 CILOSTAZOL 50MG TABLET / ORAL 2005-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077024-002 CILOSTAZOL 100MG TABLET / ORAL 2005-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077024-001 CILOSTAZOL 50MG TABLET / ORAL 2005-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077024-002 CILOSTAZOL 100MG TABLET / ORAL 2005-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077024-001 CILOSTAZOL 50MG TABLET / ORAL 2005-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077024-002 CILOSTAZOL 100MG TABLET / ORAL 2005-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077024-001 CILOSTAZOL 50MG TABLET / ORAL 2005-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077024-002 CILOSTAZOL 100MG TABLET / ORAL 2005-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077024-001 CILOSTAZOL 50MG TABLET / ORAL 2005-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077024-002 CILOSTAZOL 100MG TABLET / ORAL 2005-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077024-001 CILOSTAZOL 50MG TABLET / ORAL 2005-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077024-002 CILOSTAZOL 100MG TABLET / ORAL 2005-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077024-001 CILOSTAZOL 50MG TABLET / ORAL 2005-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077024-002 CILOSTAZOL 100MG TABLET / ORAL 2005-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077024-001 CILOSTAZOL 50MG TABLET / ORAL 2005-05-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077024-002 CILOSTAZOL 100MG TABLET / ORAL 2005-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077024-001 CILOSTAZOL 50MG TABLET / ORAL 2005-05-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077024-002 CILOSTAZOL 100MG TABLET / ORAL 2005-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077024-001 CILOSTAZOL 50MG TABLET / ORAL 2005-05-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077024-002 CILOSTAZOL 100MG TABLET / ORAL 2005-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077024-001 CILOSTAZOL 50MG TABLET / ORAL 2005-05-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077024-002 CILOSTAZOL 100MG TABLET / ORAL 2005-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077024-001 CILOSTAZOL 50MG TABLET / ORAL 2005-05-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077024-002 CILOSTAZOL 100MG TABLET / ORAL 2005-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077024-001 CILOSTAZOL 50MG TABLET / ORAL AB 2005-05-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077024-002 CILOSTAZOL 100MG TABLET / ORAL AB 2005-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077024-001 CILOSTAZOL 50MG TABLET / ORAL AB 2005-05-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077024-002 CILOSTAZOL 100MG TABLET / ORAL AB 2005-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077024-001 CILOSTAZOL 50MG TABLET / ORAL AB 2005-05-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077024-002 CILOSTAZOL 100MG TABLET / ORAL AB 2005-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077024-001 CILOSTAZOL 50MG TABLET / ORAL AB 2005-05-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077024-002 CILOSTAZOL 100MG TABLET / ORAL AB 2005-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077024-001 CILOSTAZOL 50MG TABLET / ORAL AB 2005-05-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077024-002 CILOSTAZOL 100MG TABLET / ORAL AB 2005-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077024-001 CILOSTAZOL 50MG TABLET / ORAL AB 2005-05-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077024-002 CILOSTAZOL 100MG TABLET / ORAL AB 2005-05-17 782e0a99824c…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CILOSTAZOL ACTIVE INGREDIENT N7Z035406B CILOSTAZOL TABLET [ROXANE LABORATORIES, INC] 12 CILOSTAZOL ACTIVE MOIETY N7Z035406B CILOSTAZOL TABLET [ROXANE LABORATORIES, INC] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CILOSTAZOL TABLET [ROXANE LABORATORIES, INC] 12 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CILOSTAZOL TABLET [ROXANE LABORATORIES, INC] 12 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CILOSTAZOL TABLET [ROXANE LABORATORIES, INC] 12 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CILOSTAZOL TABLET [ROXANE LABORATORIES, INC] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CILOSTAZOL TABLET [ROXANE LABORATORIES, INC] 12 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CILOSTAZOL TABLET [ROXANE LABORATORIES, INC] 12 CILOSTAZOL ACTIVE INGREDIENT N7Z035406B CILOSTAZOL TABLET [CARILION MATERIALS MANAGEMENT] 2 CILOSTAZOL ACTIVE MOIETY N7Z035406B CILOSTAZOL TABLET [CARILION MATERIALS MANAGEMENT] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CILOSTAZOL TABLET [CARILION MATERIALS MANAGEMENT] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CILOSTAZOL TABLET [CARILION MATERIALS MANAGEMENT] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CILOSTAZOL TABLET [CARILION MATERIALS MANAGEMENT] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CILOSTAZOL TABLET [CARILION MATERIALS MANAGEMENT] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CILOSTAZOL TABLET [CARILION MATERIALS MANAGEMENT] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CILOSTAZOL TABLET [CARILION MATERIALS MANAGEMENT] 2
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 0054-0044-21 00054004421 60 TABLET in 1 BOTTLE (0054-0044-21) 60 tablet 2005-05-17 0000-00-00 No No Current 0054-0044-29 00054004429 500 TABLET in 1 BOTTLE (0054-0044-29) 500 tablet 2005-05-17 0000-00-00 No No Current