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NDC 69488-0010-61 PLUVICTO 27 mCi/mL Details
PLUVICTO 27 mCi/mL
PLUVICTO is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Advanced Accelerator Applications USA, Inc. The primary component is LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN.
MedlinePlus Drug Summary
Lutetium Lu 177 vipivotide tetraxetan injection is used to treat a certain type of prostate cancer (cancer of a male reproductive gland) that has spread to other parts of the body and that has already been treated with other medications. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to cancer cells which damages and kills these cells.
Related Packages: 69488-0010-61Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Lutetium Lu 177 Vipivotide Tetraxetan Injection
Product Information
| NDC | 69488-0010 |
|---|---|
| Product ID | 69488-010_fc9c3c57-55b4-4586-a8c4-fde74e46a895 |
| Associated GPIs | 21600045802020 |
| GCN Sequence Number | 083207 |
| GCN Sequence Number Description | Lu-177 vipivotide tetraxetan VIAL 27 MCI/ML INTRAVEN |
| HIC3 | V1G |
| HIC3 Description | RADIOACTIVE THERAPEUTIC AGENTS |
| GCN | 52100 |
| HICL Sequence Number | 047914 |
| HICL Sequence Number Description | LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN |
| Brand/Generic | Brand |
| Proprietary Name | PLUVICTO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | lutetium Lu 177 vipivotide tetraxetan |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 27 |
| Active Ingredient Units | mCi/mL |
| Substance Name | LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN |
| Labeler Name | Advanced Accelerator Applications USA, Inc |
| Pharmaceutical Class | Radioligand Activity [MoA], Radioligand Therapeutic Agent [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA215833 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69488-0010-61 (69488001061)
| NDC Package Code | 69488-010-61 |
|---|---|
| Billing NDC | 69488001061 |
| Package | 1 VIAL, GLASS in 1 PACKAGE (69488-010-61) / 7.5 mL in 1 VIAL, GLASS |
| Marketing Start Date | 2022-03-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |