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NDC 00310-0512-95 CALQUENCE 100 mg/1 Details
CALQUENCE 100 mg/1
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.
MedlinePlus Drug Summary
Acalabrutinib is used to treat people with mantle cell lymphoma (MCL; a fast-growing cancer that begins in the cells of the immune system) who have already been treated with at least one other chemotherapy medication. It is also used alone or with obinutuzumab (Gazyva) to treat chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) and small lymphocytic lymphoma (SLL: a type of cancer that begins in the white blood cells). Acalabrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.
Related Packages: 00310-0512-95Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acalabrutinib
Product Information
| NDC | 00310-0512 |
|---|---|
| Product ID | 0310-0512_071b1175-2b58-47ea-80fd-395df43037a4 |
| Associated GPIs | 21532103000120 |
| GCN Sequence Number | 077883 |
| GCN Sequence Number Description | acalabrutinib CAPSULE 100 MG ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 44011 |
| HICL Sequence Number | 044607 |
| HICL Sequence Number Description | ACALABRUTINIB |
| Brand/Generic | Brand |
| Proprietary Name | CALQUENCE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acalabrutinib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, GELATIN COATED |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | ACALABRUTINIB |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| Pharmaceutical Class | Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA210259 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00310-0512-95 (00310051295)
| NDC Package Code | 0310-0512-95 |
|---|---|
| Billing NDC | 00310051295 |
| Package | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0310-0512-95) |
| Marketing Start Date | 2020-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |