Home NDC 60505-4452 Ticagrelor
Product NDC 60505-4452
11-digit product format 605054452
Labeler code 60505
Product ID 60505-4452_640ebad3-45ab-9163-21fb-b0f3117cfa82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ticagrelor
Dosage form TABLET
Route ORAL
Labeler Apotex Corp.
Application ANDA208584
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 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 A208584-001 TICAGRELOR TICAGRELOR 90MG TABLET / ORAL AB 2025-05-01 A208584-002 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.
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 A208584-001 TICAGRELOR 90MG TABLET / ORAL AB 2025-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208584-002 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208584-001 TICAGRELOR 90MG TABLET / ORAL AB 2025-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208584-002 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208584-001 TICAGRELOR 90MG TABLET / ORAL AB 2025-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208584-002 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208584-001 TICAGRELOR 90MG TABLET / ORAL AB 2025-05-01 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208584-001 TICAGRELOR 90MG TABLET / ORAL AB 2025-05-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208584-002 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1116635 Internal RxNorm lookup 1666332 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 60505-4452-6 Ticagrelor 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 60505-4452 TICAGRELOR TABLET [APOTEX CORP.] 1 Current NDC, 1 package rows 20250502_2c59ea45-6113-6e9e-70b5-3b8c8b3d89b6.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ticagrelor TICAGRELOR Golden State Medical Supply, Inc. 37f1d3d7-030f-180a-e063-6294a90a89da 2026-06-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208584 application number: ANDA208584 Ticagrelor TICAGRELOR Apotex Corp. 2c59ea45-6113-6e9e-70b5-3b8c8b3d89b6 2026-06-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208584 application number: ANDA208584 ndc (product): 60505-4452 Ticagrelor TICAGRELOR Aphena Pharma Solutions - Tennessee, LLC 41c5d35c-91de-a8a4-e063-6394a90ac5ff 2025-11-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208584 application number: ANDA208584
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60505-4452-6 60505445206 60 TABLET in 1 BOTTLE (60505-4452-6) 60 tablet 2025-05-01 No No Current