Home NDC 0310-3512 CALQUENCE
Product NDC 0310-3512
11-digit product format 003103512
Labeler code 0310
Product ID 0310-3512_7365aa18-60da-4ce6-9c06-01c80e158286
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acalabrutinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AstraZeneca Pharmaceuticals LP
Application NDA216387
Marketing category NDA
Marketing start 2022-08-04
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 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 N216387-001 CALQUENCE ACALABRUTINIB MALEATE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03
Orange Book patents# Current patent rows page 1 of 1 · 29 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216387-001 7459554 2026-11-24 Drug substance 2022-09-01 N216387-001 10239883 2032-07-11 U-2666 2022-09-01 N216387-001 10239883 2032-07-11 U-2668 2022-09-01 N216387-001 9290504 2032-07-11 Drug substance, Drug product 2022-09-01 N216387-001 9758524 2032-07-11 U-2145 2022-09-01 N216387-001 9758524 2032-07-11 U-4108 2022-09-01 N216387-001 10272083 2035-01-21 U-2519 2022-09-01 N216387-001 10272083 2035-01-21 U-2682 2022-09-01 N216387-001 10272083 2035-01-21 U-2683 2022-09-01 N216387-001 10272083 2035-01-21 U-2684 2022-09-01 N216387-001 10272083 2035-01-21 U-2685 2022-09-01 N216387-001 10272083 2035-01-21 U-2686 2022-09-01 N216387-001 10272083 2035-01-21 U-2687 2022-09-01 N216387-001 10272083 2035-01-21 U-4109 2022-09-01 N216387-001 11771696 2035-01-21 U-3710 2023-10-30 N216387-001 11166951 2035-08-11 U-4426 2026-03-18 N216387-001 11166951 2035-08-11 U-4427 2026-03-18 N216387-001 11166951 2035-08-11 U-4428 2026-03-18 N216387-001 11166951 2035-08-11 U-4429 2026-03-18 N216387-001 11166951 2035-08-11 U-4430 2026-03-18 N216387-001 11166951 2035-08-11 U-4431 2026-03-18 N216387-001 11059829 2036-07-01 U-2145 Drug substance, Drug product 2022-09-01 N216387-001 11059829 2036-07-01 U-2666 Drug substance, Drug product 2022-09-01 N216387-001 11059829 2036-07-01 U-2667 Drug substance, Drug product 2022-09-01 N216387-001 11059829 2036-07-01 U-2668 Drug substance, Drug product 2022-09-01 N216387-001 11059829 2036-07-01 U-2669 Drug substance, Drug product 2022-09-01 N216387-001 11059829 2036-07-01 U-2670 Drug substance, Drug product 2022-09-01 N216387-001 11059829 2036-07-01 U-2671 Drug substance, Drug product 2022-09-01 N216387-001 11059829 2036-07-01 U-4108 Drug substance, Drug product 2022-09-01
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216387-001 I-960 2028-01-16 N216387-001 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.
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 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 14 · 555 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 N216387-001 7459554 2026-11-24 Drug substance 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 10239883 2032-07-11 U-2666 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 10239883 2032-07-11 U-2668 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 9290504 2032-07-11 Drug substance, Drug product 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 9758524 2032-07-11 U-4108 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 9758524 2032-07-11 U-2145 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 10272083 2035-01-21 U-4109 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 10272083 2035-01-21 U-2519 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 10272083 2035-01-21 U-2682 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 10272083 2035-01-21 U-2683 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 10272083 2035-01-21 U-2684 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 10272083 2035-01-21 U-2685 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 10272083 2035-01-21 U-2686 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 10272083 2035-01-21 U-2687 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 11771696 2035-01-21 U-3710 2023-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 11059829 2036-07-01 U-4108 Drug substance, Drug product 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 11059829 2036-07-01 U-2145 Drug substance, Drug product 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 11059829 2036-07-01 U-2671 Drug substance, Drug product 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 11059829 2036-07-01 U-2670 Drug substance, Drug product 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 11059829 2036-07-01 U-2669 Drug substance, Drug product 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 11059829 2036-07-01 U-2668 Drug substance, Drug product 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 11059829 2036-07-01 U-2667 Drug substance, Drug product 2022-09-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216387-001 11059829 2036-07-01 U-2666 Drug substance, Drug product 2022-09-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 7459554 2026-11-24 Drug substance 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 10239883 2032-07-11 U-2666 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 10239883 2032-07-11 U-2668 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 9290504 2032-07-11 Drug substance, Drug product 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 9758524 2032-07-11 U-4108 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 9758524 2032-07-11 U-2145 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 10272083 2035-01-21 U-4109 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 10272083 2035-01-21 U-2519 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 10272083 2035-01-21 U-2682 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 10272083 2035-01-21 U-2683 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 10272083 2035-01-21 U-2684 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 10272083 2035-01-21 U-2685 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 10272083 2035-01-21 U-2686 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 10272083 2035-01-21 U-2687 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 11771696 2035-01-21 U-3710 2023-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 11059829 2036-07-01 U-4108 Drug substance, Drug product 2022-09-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 11059829 2036-07-01 U-2145 Drug substance, Drug product 2022-09-01 31067a03dcf5…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-02-19 14:30 UTC 2026-02 N216387-001 I-960 2028-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216387-001 I-960 2028-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216387-001 I-960 2028-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216387-001 I-960 2028-01-16 fd3edfee7708…2023-01-26 05:58 UTC 2023-01 N216387-001 NCE 2022-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N216387-001 NCE 2022-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N216387-001 NCE 2022-10-31 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216387-001 I-960 2028-01-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216387-001 D-200 2029-02-19 a50c72e98297…
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 2607734 Internal RxNorm lookup 2607737 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 0310-3512-60 CALQUENCE 60 in 1 BOTTLE TABLET, FILM COATED 60 8 0310-3512-95 CALQUENCE 60 in 1 BLISTER PACK TABLET, FILM COATED 60 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0310-3512 CALQUENCE (ACALABRUTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 7 Current NDC, Legacy NDC, 2 package rows 20250221_b1409184-3267-4d8c-8f17-4e01f69828b1.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 0310-3512-60 00310351260 60 TABLET, FILM COATED in 1 BOTTLE (0310-3512-60) 2022-08-04 0000-00-00 No No Current 0310-3512-95 00310351295 60 TABLET, FILM COATED in 1 BLISTER PACK (0310-3512-95) 2022-08-04 0000-00-00 Yes No Current