NDC 0310-0512
CALQUENCE
Acalabrutinib
CALQUENCE is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Acalabrutinib.
| Product ID | 0310-0512_0652d3f8-8cd2-4b24-9981-bd5dda1dbd9d |
| NDC | 0310-0512 |
| Product Type | Human Prescription Drug |
| Proprietary Name | CALQUENCE |
| Generic Name | Acalabrutinib |
| Dosage Form | Capsule, Gelatin Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-10-31 |
| Marketing Category | NDA / NDA |
| Application Number | NDA210259 |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| Substance Name | ACALABRUTINIB |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Kinase Inhibitor [EPC],Tyrosine Kinase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 0310-0512-60
60 CAPSULE, GELATIN COATED in 1 BOTTLE (0310-0512-60)
| Marketing Start Date | 2017-10-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0310-0512-28 [00310051228]
CALQUENCE CAPSULE, GELATIN COATED
| Marketing Category | NDA |
| Application Number | NDA210259 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-04-01 |
| Marketing End Date | 2021-07-31 |
NDC 0310-0512-60 [00310051260]
CALQUENCE CAPSULE, GELATIN COATED
| Marketing Category | NDA |
| Application Number | NDA210259 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-10-31 |
NDC 0310-0512-95 [00310051295]
CALQUENCE CAPSULE, GELATIN COATED
| Marketing Category | NDA |
| Application Number | NDA210259 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-04-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ACALABRUTINIB | 100 mg/1 |
OpenFDA Data
| SPL SET ID: | dd4835ef-e1bc-4997-a399-1ffa2556fbfe |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Kinase Inhibitor [EPC]
- Tyrosine Kinase Inhibitors [MoA]
NDC Crossover Matching brand name "CALQUENCE" or generic name "Acalabrutinib"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0310-0512 | CALQUENCE | Acalabrutinib |
| 0310-3512 | CALQUENCE | acalabrutinib |
Trademark Results [CALQUENCE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CALQUENCE 87072359 5221345 Live/Registered |
AstraZeneca AB 2016-06-15 |
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