Home NDC 55488-0544 Ticagrelor
Product NDC 55488-0544
11-digit product format 554880544
Labeler code 55488
Product ID 55488-0544_79364f10-afa0-4a5f-96d2-f82bcc9cf928
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ticagrelor
Dosage form TABLET
Route ORAL
Labeler Changzhou Pharmaceutical Factory
Application ANDA216187
Marketing category ANDA
Marketing start 2025-10-28
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 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 A216187-001 TICAGRELOR TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 A216187-002 TICAGRELOR TICAGRELOR 90MG 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 A216187-001 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216187-002 TICAGRELOR 90MG TABLET / ORAL AB 2025-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216187-001 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216187-002 TICAGRELOR 90MG TABLET / ORAL AB 2025-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216187-001 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216187-002 TICAGRELOR 90MG TABLET / ORAL AB 2025-10-28 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216187-001 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216187-002 TICAGRELOR 90MG 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TICAGRELOR 60 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 55488-0544-1 Ticagrelor 60 in 1 BOTTLE TABLET 60 1 55488-0544-2 Ticagrelor 500 in 1 BOTTLE TABLET 500 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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55488-0544-1 55488054401 60 TABLET in 1 BOTTLE (55488-0544-1) 60 tablet 2025-10-28 No No Current 55488-0544-2 55488054402 500 TABLET in 1 BOTTLE (55488-0544-2) 500 tablet 2025-10-28 No No Current