Home NDC 68083-412 Cangrelor
Product NDC 68083-412
11-digit product format 680830412
Labeler code 68083
Product ID 68083-412_706b6332-5afe-498b-a846-788e6ebc6823
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cangrelor
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA213551
Marketing category ANDA
Marketing start 2025-08-11
Substance CANGRELOR
Active strength 50 mg/1
Pharmacologic classes Decreased Platelet Aggregation [PE], 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213551-001 CANGRELOR CANGRELOR 50MG/VIAL POWDER / INTRAVENOUS AP 2025-08-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213551-001 AP
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 A213551-001 CANGRELOR 50MG/VIAL POWDER / INTRAVENOUS AP 2025-08-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213551-001 CANGRELOR 50MG/VIAL POWDER / INTRAVENOUS AP 2025-08-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213551-001 CANGRELOR 50MG/VIAL POWDER / INTRAVENOUS AP 2025-08-11 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213551-001 CANGRELOR 50MG/VIAL POWDER / INTRAVENOUS AP 2025-08-11 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A213551-001 AP 1 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213551-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213551-001 AP 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213551-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Cangrelor
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CANGRELOR 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6AQ1Y404U7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1656056 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 68083-412-10 Cangrelor 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 6 68083-412-10 Cangrelor 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 6
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 68083-412-10 68083041210 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-412-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2025-08-11 No No Current