Home NDC 84386-002 CILOSTAZOL
Product NDC 84386-002
11-digit product format 843860002
Labeler code 84386
Product ID 84386-002_7c841eed-a98f-43c3-baaf-bf5502207a69
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CILOSTAZOL
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA077019
Marketing category ANDA
Marketing start 2026-09-03
Substance CILOSTAZOL
Active strength 50 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 44 .
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 A077019-001 CILOSTAZOL CILOSTAZOL 50MG TABLET / ORAL AB 2004-11-23 A077019-002 CILOSTAZOL CILOSTAZOL 100MG TABLET / ORAL AB 2004-11-23
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 · 88 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 2026-10-15 13:18:30 2026-09 A077019-001 CILOSTAZOL 50MG TABLET / ORAL AB 2004-11-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077019-002 CILOSTAZOL 100MG TABLET / ORAL AB 2004-11-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077019-001 CILOSTAZOL 50MG TABLET / ORAL 2004-11-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077019-002 CILOSTAZOL 100MG TABLET / ORAL 2004-11-23 4b0b4de00fa7…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-10-15 13:18:30 2026-09 A077019-001 AB 1 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077019-002 AB 1 c2088c7a36db…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base CILOSTAZOL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CILOSTAZOL 50 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84386-002-60 84386000260 60 TABLET in 1 BOTTLE (84386-002-60) 60 tablet 2026-09-03 No No Current