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NDC 57894-0449-01 TECVAYLI 10 mg/mL Details
TECVAYLI 10 mg/mL
TECVAYLI is a SUBCUTANEOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is TECLISTAMAB.
Product Information
| NDC | 57894-0449 |
|---|---|
| Product ID | 57894-449_02e74249-51cc-aa03-e063-6394a90af5ab |
| Associated GPIs | |
| GCN Sequence Number | 083977 |
| GCN Sequence Number Description | teclistamab-cqyv VIAL 30 MG/3 ML SUBCUT |
| HIC3 | V1K |
| HIC3 Description | ANTINEOPLASTICS ANTIBODY/ANTIBODY-DRUG COMPLEXES |
| GCN | 53056 |
| HICL Sequence Number | 048416 |
| HICL Sequence Number Description | TECLISTAMAB-CQYV |
| Brand/Generic | Brand |
| Proprietary Name | TECVAYLI |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | teclistamab |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/mL |
| Substance Name | TECLISTAMAB |
| Labeler Name | Janssen Biotech, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761291 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 57894-0449-01 (57894044901)
| NDC Package Code | 57894-449-01 |
|---|---|
| Billing NDC | 57894044901 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-449-01) / 3 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2022-10-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |