FDA.reportPublic FDA data

CALQUENCE

Product NDC
0310-0512
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

Additional Listing Data#

Finished product
Yes
Brand name base
CALQUENCE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACALABRUTINIB100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI42748ELQW
Rxcui1986813, 1986819

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
17363798-68b2-453b-ad7a-cb3f6fd84783Product name120230323
be15ab51-1cba-4508-b944-ef4f397dfa37Product name120180103

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-0512-28CALQUENCE28 in 1 BOTTLECAPSULE, GELATIN COATED2827
0310-0512-60CALQUENCE60 in 1 BOTTLECAPSULE, GELATIN COATED6027
0310-0512-95CALQUENCE60 in 1 BOTTLECAPSULE, GELATIN COATED6027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-0512-60EA - Each0310-05126bdb875a-333b-46e5-9b2a-7e1448bbba9b12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-0512CALQUENCE (ACALABRUTINIB) CAPSULE, GELATIN COATED [ASTRAZENECA PHARMACEUTICALS LP]20Current NDC, Legacy NDC, 3 package rows20250131_dd4835ef-e1bc-4997-a399-1ffa2556fbfe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1986813acalabrutinib 100 MG Oral CapsulePSNdd4835ef-e1bc-4997-a399-1ffa2556fbfe27
1986819Calquence 100 MG Oral CapsulePSNdd4835ef-e1bc-4997-a399-1ffa2556fbfe27
1986819acalabrutinib 100 MG Oral Capsule [Calquence]SBDdd4835ef-e1bc-4997-a399-1ffa2556fbfe27
1986813acalabrutinib 100 MG Oral CapsuleSCDdd4835ef-e1bc-4997-a399-1ffa2556fbfe27
1986819Calquence 100 MG Oral CapsuleSYdd4835ef-e1bc-4997-a399-1ffa2556fbfe27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0310-0512-280031005122828 CAPSULE, GELATIN COATED in 1 BOTTLE (0310-0512-28) 2018-04-012021-07-31NoNoCurrent
0310-0512-600031005126060 CAPSULE, GELATIN COATED in 1 BOTTLE (0310-0512-60) 2017-10-310000-00-00NoNoCurrent
0310-0512-950031005129560 CAPSULE, GELATIN COATED in 1 BOTTLE (0310-0512-95) 2020-04-010000-00-00YesNoCurrent