Home NDC 0378-2214 Ticagrelor
Product NDC 0378-2214
11-digit product format 003782214
Labeler code 0378
Product ID 0378-2214_0a617b20-05c9-4a27-aa47-7b6bc5c10eec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ticagrelor
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA208597
Marketing category ANDA
Marketing start 2025-09-25
Substance TICAGRELOR
Active strength 60 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 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 A208597-001 TICAGRELOR TICAGRELOR 60MG TABLET / ORAL AB 2021-07-09 A208597-002 TICAGRELOR TICAGRELOR 90MG TABLET / ORAL AB 2021-07-09
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 2 · 72 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 A208597-001 TICAGRELOR 60MG TABLET / ORAL AB 2021-07-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208597-002 TICAGRELOR 90MG TABLET / ORAL AB 2021-07-09 c2088c7a36db…2026-09-14 22:38:34 2026-08 A208597-001 TICAGRELOR 60MG TABLET / ORAL AB 2021-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208597-002 TICAGRELOR 90MG TABLET / ORAL AB 2021-07-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208597-001 TICAGRELOR 60MG TABLET / ORAL AB 2021-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208597-002 TICAGRELOR 90MG TABLET / ORAL AB 2021-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208597-001 TICAGRELOR 60MG TABLET / ORAL AB 2021-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208597-002 TICAGRELOR 90MG TABLET / ORAL AB 2021-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208597-001 TICAGRELOR 60MG TABLET / ORAL AB 2021-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208597-002 TICAGRELOR 90MG TABLET / ORAL AB 2021-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208597-001 TICAGRELOR 60MG TABLET / ORAL AB 2021-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208597-002 TICAGRELOR 90MG TABLET / ORAL AB 2021-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208597-001 TICAGRELOR 60MG TABLET / ORAL 2021-07-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208597-002 TICAGRELOR 90MG TABLET / ORAL 2021-07-09 4b0b4de00fa7…
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 60 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0378-2214-05 Ticagrelor 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 1 0378-2214-80 Ticagrelor 180 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 180 1 0378-2214-91 Ticagrelor 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0378-2214-05 00378221405 500 in 1 BOTTLE, PLASTIC Historical 0378-2214-80 00378221480 180 in 1 BOTTLE, PLASTIC Historical 0378-2214-91 00378221491 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2214-91) 2025-09-25 No No Current