Home NDC 67877-491 Ticagrelor
Product NDC 67877-491
11-digit product format 678770491
Labeler code 67877
Product ID 67877-491_8e5ef2f6-0073-4a1a-8566-78d18601954f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ticagrelor
Dosage form TABLET
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA208567
Marketing category ANDA
Marketing start 2025-04-30
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 43 .
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 A208567-001 TICAGRELOR TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208567-001 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.
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 2026-09-14 22:38:34 2026-08 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208567-001 TICAGRELOR 90MG TABLET / ORAL AB 2023-04-21 a50c72e98297…
Observed Orange Book normalized TE history# 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 Ticagrelor
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TICAGRELOR 90 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67877-491-05 Ticagrelor 500 in 1 BOTTLE TABLET 500 19 67877-491-60 Ticagrelor 60 in 1 BOTTLE TABLET 60 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-491 TICAGRELOR TABLET [ASCEND LABORATORIES, LLC] 16 Current NDC, 2 package rows 20250430_2f73a4db-2c7f-4e42-a914-87aedc2780fb.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67877-491-05 67877049105 500 TABLET in 1 BOTTLE (67877-491-05) 500 tablet 2026-03-05 No No Current 67877-491-60 67877049160 60 TABLET in 1 BOTTLE (67877-491-60) 60 tablet 2025-04-30 No No Current