Home NDC 0310-0512-60 CALQUENCE
Product NDC 0310-0512
Requested package NDC 0310-0512-60
11-digit product format 003100512
Labeler code 0310
Product ID 0310-0512_aa4e8627-21c7-413a-9d0d-1957ded93283
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acalabrutinib
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler AstraZeneca Pharmaceuticals LP
Application NDA210259
Marketing category NDA
Marketing start 2017-10-31
Substance ACALABRUTINIB
Active strength 100 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0310-0512 0310-0512-60 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0310-0512 0310-0512-60 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 N210259-001 CALQUENCE ACALABRUTINIB 100MG CAPSULE / ORAL RLD, RS 2017-10-31
Orange Book patents# Current patent rows page 1 of 1 · 44 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210259-001 7459554 2026-11-24 Drug substance 2018-04-13 N210259-001 10239883 2032-07-11 U-2666 2019-12-12 N210259-001 10239883 2032-07-11 U-2668 2019-12-12 N210259-001 9290504 2032-07-11 Drug substance, Drug product 2017-11-28 N210259-001 9758524 2032-07-11 U-2145 2017-11-28 N210259-001 9758524 2032-07-11 U-4108 2017-11-28 N210259-001 10272083 2035-01-21 U-2519 2019-05-22 N210259-001 10272083 2035-01-21 U-2682 2019-05-22 N210259-001 10272083 2035-01-21 U-2683 2019-05-22 N210259-001 10272083 2035-01-21 U-2684 2019-05-22 N210259-001 10272083 2035-01-21 U-2685 2019-05-22 N210259-001 10272083 2035-01-21 U-2686 2019-05-22 N210259-001 10272083 2035-01-21 U-2687 2019-05-22 N210259-001 10272083 2035-01-21 U-4109 2019-05-22 N210259-001 11771696 2035-01-21 U-3710 2023-10-30 N210259-001 11166951 2035-08-11 U-4426 2026-03-18 N210259-001 11166951 2035-08-11 U-4427 2026-03-18 N210259-001 11166951 2035-08-11 U-4428 2026-03-18 N210259-001 11166951 2035-08-11 U-4429 2026-03-18 N210259-001 11166951 2035-08-11 U-4430 2026-03-18 N210259-001 11166951 2035-08-11 U-4431 2026-03-18 N210259-001 10167291 2036-07-01 U-2145 Drug product 2019-01-24 N210259-001 10167291 2036-07-01 U-2519 Drug product 2019-01-24 N210259-001 10167291 2036-07-01 U-2666 Drug product 2019-01-24 N210259-001 10167291 2036-07-01 U-2667 Drug product 2019-01-24 N210259-001 10167291 2036-07-01 U-2668 Drug product 2019-01-24 N210259-001 10167291 2036-07-01 U-2669 Drug product 2019-01-24 N210259-001 10167291 2036-07-01 U-2670 Drug product 2019-01-24 N210259-001 10167291 2036-07-01 U-2671 Drug product 2019-01-24 N210259-001 10167291 2036-07-01 U-2682 Drug product 2019-01-24 N210259-001 10167291 2036-07-01 U-2683 Drug product 2019-01-24 N210259-001 10167291 2036-07-01 U-2684 Drug product 2019-01-24 N210259-001 10167291 2036-07-01 U-2685 Drug product 2019-01-24 N210259-001 10167291 2036-07-01 U-2686 Drug product 2019-01-24 N210259-001 10167291 2036-07-01 U-2687 Drug product 2019-01-24 N210259-001 10167291 2036-07-01 U-4109 Drug product 2019-01-24 N210259-001 9796721 2036-07-01 U-2145 Drug substance, Drug product 2017-11-28 N210259-001 9796721 2036-07-01 U-2666 Drug substance, Drug product 2017-11-28 N210259-001 9796721 2036-07-01 U-2667 Drug substance, Drug product 2017-11-28 N210259-001 9796721 2036-07-01 U-2668 Drug substance, Drug product 2017-11-28 N210259-001 9796721 2036-07-01 U-2669 Drug substance, Drug product 2017-11-28 N210259-001 9796721 2036-07-01 U-2670 Drug substance, Drug product 2017-11-28 N210259-001 9796721 2036-07-01 U-2671 Drug substance, Drug product 2017-11-28 N210259-001 9796721 2036-07-01 U-4108 Drug substance, Drug product 2017-11-28
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210259-001 ODE-274 2026-11-21 N210259-001 I-960 2028-01-16 N210259-001 D-200 2029-02-19
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210259-001 CALQUENCE 100MG CAPSULE / ORAL RLD, RS 2017-10-31 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 27 · 1,068 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210259-001 7459554 2026-11-24 Drug substance 2018-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10239883 2032-07-11 U-2668 2019-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10239883 2032-07-11 U-2666 2019-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 9290504 2032-07-11 Drug substance, Drug product 2017-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 9758524 2032-07-11 U-4108 2017-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 9758524 2032-07-11 U-2145 2017-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10272083 2035-01-21 U-2519 2019-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10272083 2035-01-21 U-2683 2019-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10272083 2035-01-21 U-2686 2019-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10272083 2035-01-21 U-2684 2019-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10272083 2035-01-21 U-2687 2019-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10272083 2035-01-21 U-2682 2019-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10272083 2035-01-21 U-2685 2019-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10272083 2035-01-21 U-4109 2019-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 11771696 2035-01-21 U-3710 2023-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10167291 2036-07-01 U-2667 Drug product 2019-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10167291 2036-07-01 U-2670 Drug product 2019-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10167291 2036-07-01 U-2666 Drug product 2019-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10167291 2036-07-01 U-2668 Drug product 2019-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10167291 2036-07-01 U-2669 Drug product 2019-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10167291 2036-07-01 U-2671 Drug product 2019-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10167291 2036-07-01 U-4109 Drug product 2019-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10167291 2036-07-01 U-2519 Drug product 2019-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10167291 2036-07-01 U-2684 Drug product 2019-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10167291 2036-07-01 U-2685 Drug product 2019-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10167291 2036-07-01 U-2682 Drug product 2019-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10167291 2036-07-01 U-2683 Drug product 2019-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10167291 2036-07-01 U-2687 Drug product 2019-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10167291 2036-07-01 U-2686 Drug product 2019-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 10167291 2036-07-01 U-2145 Drug product 2019-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 9796721 2036-07-01 U-2145 Drug substance, Drug product 2017-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 9796721 2036-07-01 U-2669 Drug substance, Drug product 2017-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 9796721 2036-07-01 U-2671 Drug substance, Drug product 2017-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 9796721 2036-07-01 U-2670 Drug substance, Drug product 2017-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 9796721 2036-07-01 U-2668 Drug substance, Drug product 2017-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 9796721 2036-07-01 U-2666 Drug substance, Drug product 2017-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 9796721 2036-07-01 U-2667 Drug substance, Drug product 2017-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210259-001 9796721 2036-07-01 U-4108 Drug substance, Drug product 2017-11-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210259-001 7459554 2026-11-24 Drug substance 2018-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210259-001 10239883 2032-07-11 U-2668 2019-12-12 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 111 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CALQUENCE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACALABRUTINIB 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination I42748ELQW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1986813 Internal RxNorm lookup 1986819 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 0310-0512-28 CALQUENCE 28 in 1 BOTTLE CAPSULE, GELATIN COATED 28 27 0310-0512-60 CALQUENCE 60 in 1 BOTTLE CAPSULE, GELATIN COATED 60 27 0310-0512-95 CALQUENCE 60 in 1 BOTTLE CAPSULE, GELATIN COATED 60 27
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0310-0512 CALQUENCE (ACALABRUTINIB) CAPSULE, GELATIN COATED [ASTRAZENECA PHARMACEUTICALS LP] 20 Current NDC, Legacy NDC, 3 package rows 20250131_dd4835ef-e1bc-4997-a399-1ffa2556fbfe.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 0310-0512-60 00310051260 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0310-0512-60) 2017-10-31 0000-00-00 No No Current