Home NDC 67877-522-18 Ticagrelor
Product NDC 67877-522
Requested package NDC 67877-522-18
11-digit product format 678770522
Labeler code 67877
Product ID 67877-522_0e2da4e0-7930-4f20-a63e-bd8b75cfb47d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ticagrelor
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA210219
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 1 .
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 A210219-001 TICAGRELOR TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210219-001 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 2026-02-19 14:30 UTC 2026-02 A210219-001 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210219-001 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210219-001 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A210219-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210219-001 AB 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210219-001 AB 1 a50c72e98297…
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 67877-522-05 Ticagrelor 500 in 1 BOTTLE TABLET, FILM COATED 500 10 67877-522-14 Ticagrelor 14 in 1 BOTTLE TABLET, FILM COATED 14 10 67877-522-18 Ticagrelor 180 in 1 BOTTLE TABLET, FILM COATED 180 10 67877-522-38 Ticagrelor 10 in 1 BLISTER PACK TABLET, FILM COATED 10 10 67877-522-38 Ticagrelor 10 in 1 CARTON TABLET, FILM COATED 10 10 67877-522-60 Ticagrelor 60 in 1 BOTTLE TABLET, FILM COATED 60 10
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 67877-522-18 67877052218 180 TABLET, FILM COATED in 1 BOTTLE (67877-522-18) 2025-10-28 No No Current