CALQUENCE

Product NDC: 0310-4513
11-digit product format: 003104513
Labeler code: 0310
Product ID: 0310-4513_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	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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b1409184-3267-4d8c-8f17-4e01f69828b1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
17363798-68b2-453b-ad7a-cb3f6fd84783	Product name	1	20230323
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
be15ab51-1cba-4508-b944-ef4f397dfa37	Product name	1	20180103
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-4513-60	EA - Each	0310-4513	eacc95fe-0b33-459c-9075-fe8da67ad197	1	2025-03-04

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

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CALQUENCE	ACALABRUTINIB	AstraZeneca Pharmaceuticals LP	b1409184-3267-4d8c-8f17-4e01f69828b1	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216387 application number: NDA216387 ndc (product): 0310-4513

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I42748ELQW	ACALABRUTINIB	1420477-60-6	ACALABRUTINIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2607734	acalabrutinib 100 MG Oral Tablet	PSN	b1409184-3267-4d8c-8f17-4e01f69828b1	8
2607737	CALQUENCE 100 MG Oral Tablet	PSN	b1409184-3267-4d8c-8f17-4e01f69828b1	8
2607737	acalabrutinib 100 MG Oral Tablet [Calquence]	SBD	b1409184-3267-4d8c-8f17-4e01f69828b1	8
2607734	acalabrutinib 100 MG Oral Tablet	SCD	b1409184-3267-4d8c-8f17-4e01f69828b1	8
2607734	acalabrutinib 100 MG (as acalabrutinib maleate 129 MG) Oral Tablet	SY	b1409184-3267-4d8c-8f17-4e01f69828b1	8
2607737	Calquence 100 MG Oral Tablet	SY	b1409184-3267-4d8c-8f17-4e01f69828b1	8

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