Home NDC 33342-432 Ticagrelor
Product NDC 33342-432
11-digit product format 333420432
Labeler code 33342
Product ID 33342-432_32769721-c1dd-4bd3-90aa-a6cab59d3cd6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ticagrelor
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA212258
Marketing category ANDA
Marketing start 2025-10-28
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 A212258-001 TICAGRELOR TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 A212258-002 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 A212258-001 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212258-002 TICAGRELOR 90MG TABLET / ORAL AB 2025-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212258-001 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212258-002 TICAGRELOR 90MG TABLET / ORAL AB 2025-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212258-001 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212258-002 TICAGRELOR 90MG TABLET / ORAL AB 2025-10-28 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212258-001 TICAGRELOR 60MG TABLET / ORAL AB 2025-10-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212258-002 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 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 33342-432-09 Ticagrelor 60 in 1 BOTTLE TABLET, FILM COATED 60 1 33342-432-12 Ticagrelor 10 in 1 CARTON TABLET, FILM COATED 10 1 33342-432-12 Ticagrelor 10 in 1 BLISTER PACK TABLET, FILM COATED 10 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 33342-432-09 33342043209 60 TABLET, FILM COATED in 1 BOTTLE (33342-432-09) 2025-10-28 No No Current 33342-432-12 33342043212 10 BLISTER PACK in 1 CARTON (33342-432-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2025-10-28 No No Current