Home NDC 50268-826 TICAGRELOR
Product NDC 50268-826
11-digit product format 502680826
Labeler code 50268
Product ID 50268-826_42501349-0107-5655-e063-6394a90a9b0c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TICAGRELOR
Dosage form TABLET
Route ORAL
Labeler AvPAK
Application ANDA208596
Marketing category ANDA
Marketing start 2025-10-29
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 2026-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208596-001 TICAGRELOR TICAGRELOR 90MG TABLET / ORAL AB 2020-04-07 A208596-002 TICAGRELOR TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28
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 · 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 A208596-001 TICAGRELOR 90MG TABLET / ORAL AB 2020-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208596-002 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208596-001 TICAGRELOR 90MG TABLET / ORAL AB 2020-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208596-002 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208596-001 TICAGRELOR 90MG TABLET / ORAL AB 2020-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208596-002 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208596-001 TICAGRELOR 90MG TABLET / ORAL AB 2020-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208596-001 TICAGRELOR 90MG TABLET / ORAL AB 2020-04-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208596-001 TICAGRELOR 90MG TABLET / ORAL AB 2020-04-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208596-001 TICAGRELOR 90MG TABLET / ORAL AB 2020-04-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208596-001 TICAGRELOR 90MG TABLET / ORAL AB 2020-04-07 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208596-001 TICAGRELOR 90MG TABLET / ORAL 2020-04-07 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base TICAGRELOR
Listing expiration 2026-12-31 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 50268-826-01 TICAGRELOR 100 in 1 BOX TABLET 100 1 50268-826-11 TICAGRELOR 1 in 1 BLISTER PACK TABLET 1 1
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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TICAGRELOR TICAGRELOR Novadoz Pharmaceuticals LLC b1c29d47-960f-4fc4-b6ff-399e2c6eec4c 2026-02-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208596 application number: ANDA208596 Ticagrelor TICAGRELOR American Health Packaging a50eb0b4-1bee-4781-8eba-75e324540d36 2026-01-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208596 application number: ANDA208596 TICAGRELOR TICAGRELOR AvPAK 425024ab-e092-7a6d-e063-6294a90ae4f3 2025-10-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208596 application number: ANDA208596 ndc (product): 50268-826 TICAGRELOR TICAGRELOR AvKARE 40bb0fb0-2275-4df7-e063-6394a90ade2e 2025-10-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208596 application number: ANDA208596 TICAGRELOR TICAGRELOR AvKARE 32ebf046-73e4-b11b-e063-6294a90a5bf4 2025-04-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208596 application number: ANDA208596
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50268-826-01 50268082601 100 BLISTER PACK in 1 BOX (50268-826-01) / 1 TABLET in 1 BLISTER PACK (50268-826-11) 100 blister pack 2025-10-29 No No Current 50268-826-11 50268082611 1 in 1 BLISTER PACK Historical