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NDC 00078-0846-19 KYMRIAH 2000000 1-Jan Details
KYMRIAH 2000000 1-Jan
KYMRIAH is a INTRAVENOUS INJECTION, SUSPENSION in the CELLULAR THERAPY category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is TISAGENLECLEUCEL.
MedlinePlus Drug Summary
Tisagenlecleucel injection is used to treat certain acute lymphoblastic leukemia (ALL; also called acute lymphoblastic leukemia and acute lymphatic leukemia; a type of cancer that begins in the white blood cells) in people 25 years of age or younger that has returned or is unresponsive to other treatment(s). It is also used to treat a certain type of non-Hodgkin's lymphoma (type of cancer that begins in a type of white blood cells that normally fights infection) and follicular lymphoma (FL; a slow-growing cancer that begins in the white blood cells) in adults that has returned or is unresponsive after treatment with at least two other medications. Tisagenlecleucel injection is in a class of medications called autologous cellular immunotherapy, a type of medication prepared using cells from the patient's own blood. It works by causing the body's immune system (a group of cells, tissues, and organs that protects the body from attack by bacteria, viruses, cancer cells, and other substances that cause disease) to fight the cancer cells.
Related Packages: 00078-0846-19Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tisagenlecleucel Injection
Product Information
| NDC | 00078-0846 |
|---|---|
| Product ID | 0078-0846_08df395a-a319-42f9-b39b-2582b6644997 |
| Associated GPIs | 21651075001820 |
| GCN Sequence Number | 077696 |
| GCN Sequence Number Description | tisagenlecleucel PLAST. BAG 2.5X10EXP8 INTRAVEN |
| HIC3 | V35 |
| HIC3 Description | ANTINEOPLASTIC - CAR-T CELL IMMUNOTHERAPY |
| GCN | 43799 |
| HICL Sequence Number | 044483 |
| HICL Sequence Number Description | TISAGENLECLEUCEL |
| Brand/Generic | Brand |
| Proprietary Name | KYMRIAH |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | tisagenlecleucel |
| Product Type | CELLULAR THERAPY |
| Dosage Form | INJECTION, SUSPENSION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 2000000 |
| Active Ingredient Units | 1-Jan |
| Substance Name | TISAGENLECLEUCEL |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Pharmaceutical Class | CD19 Receptor Interactions [MoA], CD19-directed Chimeric Antigen Receptor [EPC], CD19-specific Chimeric Antigen Receptor [CS], Genetically-modified Autologous T Cells [EPC], Increased T Lymphocyte Activation [PE], T Lymphocytes, Cultured, Autologous, Gene |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125646 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00078-0846-19 (00078084619)
| NDC Package Code | 0078-0846-19 |
|---|---|
| Billing NDC | 00078084619 |
| Package | 1 INJECTION, SUSPENSION in 1 BAG (0078-0846-19) |
| Marketing Start Date | 2017-08-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |