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NDC 57894-0111-01 CARVYKTI 100000000 1-Jan Details
CARVYKTI 100000000 1-Jan
CARVYKTI is a INTRAVENOUS INJECTION, SUSPENSION in the CELLULAR THERAPY category. It is labeled and distributed by Janssen Biotech, Inc. The primary component is CILTACABTAGENE AUTOLEUCEL.
MedlinePlus Drug Summary
Ciltacabtagene autoleucel is used to treat multiple myeloma (a type of cancer of the bone marrow) in adults that has returned or that did not respond to at least 4 other treatments. Ciltacabtagene autoleucel 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: 57894-0111-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ciltacabtagene Autoleucel Injection
Product Information
| NDC | 57894-0111 |
|---|---|
| Product ID | 57894-111_0d94e55a-8ea5-c58a-e063-6394a90ada9e |
| Associated GPIs | 21651025101820 |
| GCN Sequence Number | 083125 |
| GCN Sequence Number Description | ciltacabtagene autoleucel PLAST. BAG 1X10EXP8 INTRAVEN |
| HIC3 | V35 |
| HIC3 Description | ANTINEOPLASTIC - CAR-T CELL IMMUNOTHERAPY |
| GCN | 52002 |
| HICL Sequence Number | 047873 |
| HICL Sequence Number Description | CILTACABTAGENE AUTOLEUCEL |
| Brand/Generic | Brand |
| Proprietary Name | CARVYKTI |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ciltacabtagene autoleucel |
| Product Type | CELLULAR THERAPY |
| Dosage Form | INJECTION, SUSPENSION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 100000000 |
| Active Ingredient Units | 1-Jan |
| Substance Name | CILTACABTAGENE AUTOLEUCEL |
| Labeler Name | Janssen Biotech, Inc |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125746 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 57894-0111-01 (57894011101)
| NDC Package Code | 57894-111-01 |
|---|---|
| Billing NDC | 57894011101 |
| Package | 1 INJECTION, SUSPENSION in 1 BAG (57894-111-01) |
| Marketing Start Date | 2022-02-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |