Home NDC 72189-116 CILOSTAZOL
Product NDC 72189-116
11-digit product format 721890116
Labeler code 72189
Product ID 72189-116_2be8fd92-0c90-d751-e063-6394a90af165
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CILOSTAZOL
Dosage form TABLET
Route ORAL
Labeler direct rx
Application ANDA077027
Marketing category ANDA
Marketing start 2020-12-02
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 72189-116 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-116 72189-116-60 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 72189-116-60 CILOSTAZOL 60 in 1 BOTTLE TABLET 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-116 CILOSTAZOL TABLET [DIRECT RX] 2 Current NDC, Legacy NDC, 1 package rows 20250119_b57d3c1e-e36f-5255-e053-2a95a90ada83.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 ndc (product): 72189-116 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
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 72189-116-60 72189011660 60 TABLET in 1 BOTTLE (72189-116-60) 60 tablet 2020-12-02 0000-00-00 No No Current