Home NDC 42658-115 Ticagrelor
Product NDC 42658-115
11-digit product format 426580115
Labeler code 42658
Product ID 42658-115_4bdf0e1b-391f-302e-e063-6294a90ac357
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ticagrelor
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Hisun Pharmaceuticals USA, Inc.
Application ANDA208575
Marketing category ANDA
Marketing start 2025-05-01
Substance TICAGRELOR
Active strength 90 mg/1
Pharmacologic classes Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [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 42 .
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 A208575-001 TICAGRELOR TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208575-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208575-001 TICAGRELOR 90MG TABLET / ORAL AB 2019-01-23 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ticagrelor
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TICAGRELOR 90 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination GLH0314RVC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1116635 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 42658-115-03 Ticagrelor 60 in 1 BOTTLE TABLET, FILM COATED 60 10 42658-115-07 Ticagrelor 500 in 1 BOTTLE TABLET, FILM COATED 500 10 42658-115-10 Ticagrelor 180 in 1 BOTTLE TABLET, FILM COATED 180 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42658-115 TICAGRELOR TABLET, FILM COATED [HISUN PHARMACEUTICALS USA, INC.] 9 Current NDC, 3 package rows 20250105_c4c1ca82-99bd-451a-ad77-7fe28c4ae3e8.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42658-115-03 42658011503 60 TABLET, FILM COATED in 1 BOTTLE (42658-115-03) 2025-05-01 No No Current 42658-115-07 42658011507 500 in 1 BOTTLE Historical 42658-115-10 42658011510 180 in 1 BOTTLE Historical