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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I42748ELQW |
| Rxcui | 2607734, 2607737 |
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 |