Home NDC 0310-4513 CALQUENCE
Product NDC 0310-4513
11-digit product format 003104513
Labeler code 0310
Product ID 0310-4513_e44946d3-2c12-487b-ba00-4f9421278951
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 44 .
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 2026-10-15 13:18:30 2026-09 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216387-001 CALQUENCE EQ 100MG BASE TABLET / ORAL RLD, RS 2022-08-03 caaa826d4ba7…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 17 · 642 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N216387-001 7459554 2026-11-24 Drug substance 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 10239883 2032-07-11 U-2666 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 10239883 2032-07-11 U-2668 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 9290504 2032-07-11 Drug substance, Drug product 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 9758524 2032-07-11 U-4108 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 9758524 2032-07-11 U-2145 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 10272083 2035-01-21 U-4109 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 10272083 2035-01-21 U-2519 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 10272083 2035-01-21 U-2682 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 10272083 2035-01-21 U-2683 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 10272083 2035-01-21 U-2684 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 10272083 2035-01-21 U-2685 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 10272083 2035-01-21 U-2686 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 10272083 2035-01-21 U-2687 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 11771696 2035-01-21 U-3710 2023-10-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 11166951 2035-08-11 U-4426 2026-03-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 11166951 2035-08-11 U-4427 2026-03-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 11166951 2035-08-11 U-4428 2026-03-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 11166951 2035-08-11 U-4429 2026-03-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 11166951 2035-08-11 U-4430 2026-03-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 11166951 2035-08-11 U-4431 2026-03-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 11059829 2036-07-01 U-4108 Drug substance, Drug product 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 11059829 2036-07-01 U-2145 Drug substance, Drug product 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 11059829 2036-07-01 U-2671 Drug substance, Drug product 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 11059829 2036-07-01 U-2670 Drug substance, Drug product 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 11059829 2036-07-01 U-2669 Drug substance, Drug product 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 11059829 2036-07-01 U-2668 Drug substance, Drug product 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 11059829 2036-07-01 U-2667 Drug substance, Drug product 2022-09-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216387-001 11059829 2036-07-01 U-2666 Drug substance, Drug product 2022-09-01 c2088c7a36db…2026-09-14 22:38:34 2026-08 N216387-001 7459554 2026-11-24 Drug substance 2022-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216387-001 10239883 2032-07-11 U-2666 2022-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216387-001 10239883 2032-07-11 U-2668 2022-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216387-001 9290504 2032-07-11 Drug substance, Drug product 2022-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216387-001 9758524 2032-07-11 U-4108 2022-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216387-001 9758524 2032-07-11 U-2145 2022-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216387-001 10272083 2035-01-21 U-4109 2022-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216387-001 10272083 2035-01-21 U-2519 2022-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216387-001 10272083 2035-01-21 U-2682 2022-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216387-001 10272083 2035-01-21 U-2683 2022-09-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216387-001 10272083 2035-01-21 U-2684 2022-09-01 84e616aacf4f…
Observed Orange Book exclusivity history# 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 CALQUENCE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACALABRUTINIB 100 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0310-4513-60 CALQUENCE 60 in 1 BOTTLE TABLET, FILM COATED 60 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0310-4513 CALQUENCE (ACALABRUTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 7 Current NDC, 1 package rows 20250221_b1409184-3267-4d8c-8f17-4e01f69828b1.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0310-4513-60 00310451360 60 TABLET, FILM COATED in 1 BOTTLE (0310-4513-60) 2025-02-19 No No Current