Home NDC 0093-2065 Cilostazol
Product NDC 0093-2065
11-digit product format 000932065
Labeler code 0093
Product ID 0093-2065_01457771-0b8c-4f1b-8513-01ad09ac97cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cilostazol
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA077027
Marketing category ANDA
Marketing start 2012-04-24
Substance CILOSTAZOL
Active strength 50 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 A077027-001 CILOSTAZOL CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 A077027-002 CILOSTAZOL CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24
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 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077027-001 CILOSTAZOL 50MG TABLET / ORAL AB RS 2004-11-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077027-002 CILOSTAZOL 100MG TABLET / ORAL AB RS 2004-11-24 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 50 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 0093-2065-06 Cilostazol 60 in 1 BOTTLE TABLET 60 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CILOSTAZOL ACTIVE INGREDIENT N7Z035406B CILOSTAZOL TABLET [TEVA PHARMACEUTICALS USA INC] 7 CILOSTAZOL ACTIVE MOIETY N7Z035406B CILOSTAZOL TABLET [TEVA PHARMACEUTICALS USA INC] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CILOSTAZOL TABLET [TEVA PHARMACEUTICALS USA INC] 7 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CILOSTAZOL TABLET [TEVA PHARMACEUTICALS USA INC] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CILOSTAZOL TABLET [TEVA PHARMACEUTICALS USA INC] 7 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X CILOSTAZOL TABLET [TEVA PHARMACEUTICALS USA INC] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CILOSTAZOL TABLET [TEVA PHARMACEUTICALS USA INC] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CILOSTAZOL TABLET [TEVA PHARMACEUTICALS USA INC] 7 CILOSTAZOL ACTIVE INGREDIENT N7Z035406B CILOSTAZOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 CILOSTAZOL ACTIVE MOIETY N7Z035406B CILOSTAZOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CILOSTAZOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CILOSTAZOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CILOSTAZOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 POVIDONES INACTIVE INGREDIENT FZ989GH94E CILOSTAZOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CILOSTAZOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CILOSTAZOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-2065 CILOSTAZOL TABLET [TEVA PHARMACEUTICALS USA, INC.] 16 Current NDC, Legacy NDC, 1 package rows 20230329_a6292311-9cb2-49ff-b8bf-12e2dbd196cd.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CILOSTAZOL CILOSTAZOL direct rx b57d3c1e-e36f-5255-e053-2a95a90ada83 2025-01-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077027 application number: ANDA077027 Cilostazol CILOSTAZOL Bryant Ranch Prepack f728395c-684c-4087-a389-c323dbcb72dd 2024-08-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077027 application number: ANDA077027 Cilostazol CILOSTAZOL Bryant Ranch Prepack 53486382-eee0-4cbe-bc4a-a57484e0d5a7 2024-01-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077027 application number: ANDA077027 Cilostazol CILOSTAZOL Teva Pharmaceuticals USA, Inc. a6292311-9cb2-49ff-b8bf-12e2dbd196cd 2022-07-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077027 application number: ANDA077027 ndc (product): 0093-2065
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 0093-2065-06 00093206506 60 TABLET in 1 BOTTLE (0093-2065-06) 60 tablet 2012-04-24 0000-00-00 No No Current