Home NDC 10122-620 KENGREAL
Product NDC 10122-620
11-digit product format 101220620
Labeler code 10122
Product ID 10122-620_8c5e6180-c346-48e7-818d-471089de4ee7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cangrelor
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Chiesi USA, Inc.
Application NDA204958
Marketing category NDA
Marketing start 2015-07-08
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 N204958-001 KENGREAL CANGRELOR 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2015-06-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N204958-001 AP
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204958-001 9925265 2029-05-13 U-2260 2018-04-11 N204958-001 9427448 2030-11-10 U-1926 2016-12-09 N204958-001 8680052 2033-03-09 U-2979 2015-07-16 N204958-001 10039780 2035-07-10 U-2260 2018-08-30 N204958-001 9295687 2035-07-10 Drug product 2016-03-29 N204958-001 9439921 2035-07-10 Drug product 2016-12-09 N204958-001 9700575 2035-07-10 Drug product 2017-07-28
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.
Product history page 1 of 2 · 42 observed 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 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2015-06-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2015-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2015-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N204958-001 KENGREAL 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2015-06-22 e64feba35796…
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 N204958-001 AP 1 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204958-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204958-001 AP 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N204958-001 AP 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 9 · 322 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N204958-001 9925265 2029-05-13 U-2260 2018-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204958-001 9427448 2030-11-10 U-1926 2016-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204958-001 8680052 2033-03-09 U-2979 2015-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204958-001 10039780 2035-07-10 U-2260 2018-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204958-001 9295687 2035-07-10 Drug product 2016-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204958-001 9439921 2035-07-10 Drug product 2016-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204958-001 9700575 2035-07-10 Drug product 2017-07-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204958-001 9925265 2029-05-13 U-2260 2018-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204958-001 9427448 2030-11-10 U-1926 2016-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204958-001 8680052 2033-03-09 U-2979 2015-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204958-001 10039780 2035-07-10 U-2260 2018-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204958-001 9295687 2035-07-10 Drug product 2016-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204958-001 9439921 2035-07-10 Drug product 2016-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204958-001 9700575 2035-07-10 Drug product 2017-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204958-001 9925265 2029-05-13 U-2260 2018-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204958-001 9427448 2030-11-10 U-1926 2016-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204958-001 8680052 2033-03-09 U-2979 2015-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204958-001 10039780 2035-07-10 U-2260 2018-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204958-001 9295687 2035-07-10 Drug product 2016-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204958-001 9439921 2035-07-10 Drug product 2016-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204958-001 9700575 2035-07-10 Drug product 2017-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204958-001 9925265 2029-05-13 U-2260 2018-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204958-001 9427448 2030-11-10 U-1926 2016-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204958-001 8680052 2033-03-09 U-2979 2015-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204958-001 10039780 2035-07-10 U-2260 2018-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204958-001 9295687 2035-07-10 Drug product 2016-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204958-001 9439921 2035-07-10 Drug product 2016-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204958-001 9700575 2035-07-10 Drug product 2017-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204958-001 9925265 2029-05-13 U-2260 2018-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204958-001 9427448 2030-11-10 U-1926 2016-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204958-001 8680052 2033-03-09 U-2979 2015-07-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204958-001 10039780 2035-07-10 U-2260 2018-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204958-001 9295687 2035-07-10 Drug product 2016-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204958-001 9439921 2035-07-10 Drug product 2016-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204958-001 9700575 2035-07-10 Drug product 2017-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204958-001 9925265 2029-05-13 U-2260 2018-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204958-001 9427448 2030-11-10 U-1926 2016-12-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204958-001 8680052 2033-03-09 U-2979 2015-07-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204958-001 10039780 2035-07-10 U-2260 2018-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204958-001 9295687 2035-07-10 Drug product 2016-03-29 b8a1b40f171c…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base KENGREAL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1656056 Internal RxNorm lookup 1656061 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 10122-620-01 KENGREAL 1 in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 1 10 10122-620-10 KENGREAL 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10122-620 KENGREAL (CANGRELOR) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CHIESI USA, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20220928_88b434fa-8891-4fd5-9d86-7ea64667c08f.zip
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 Marketing end Sample Exclude flag Status 10122-620-01 10122062001 1 in 1 VIAL, SINGLE-USE Historical 10122-620-10 10122062010 10 VIAL, SINGLE-USE in 1 CARTON (10122-620-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (10122-620-01) 2015-07-08 0000-00-00 No No Current