Home NDC 42385-993-72 Ticagrelor
Product NDC 42385-993
Requested package NDC 42385-993-72
11-digit product format 423850993
Labeler code 42385
Product ID 42385-993_555d4e44-9bb2-474e-9bea-c549e3261dbb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ticagrelor
Dosage form TABLET
Route ORAL
Labeler Laurus Labs Limited
Application ANDA218869
Marketing category ANDA
Marketing start 2026-08-20
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A218869-001 TICAGRELOR TICAGRELOR 60MG TABLET / ORAL AB 2026-08-20 A218869-002 TICAGRELOR TICAGRELOR 90MG TABLET / ORAL AB 2026-08-20
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 2026-09-14 22:38:34 2026-08 A218869-001 TICAGRELOR 60MG TABLET / ORAL AB 2026-08-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218869-002 TICAGRELOR 90MG TABLET / ORAL AB 2026-08-20 84e616aacf4f…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A218869-001 AB 1 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218869-002 AB 1 84e616aacf4f…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ticagrelor
Listing expiration 2027-12-31 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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42385-993-72 42385099372 10 BLISTER PACK in 1 CARTON (42385-993-72) / 10 TABLET in 1 BLISTER PACK (42385-993-17) 10 blister pack 2026-08-20 No No Current