PLUVICTO
- Product NDC
- 0078-1217
- 11-digit product format
- 000781217
- Labeler code
- 0078
- Product ID
- 0078-1217_4d7d1071-153c-4073-9a10-1a4185778dfe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lutetium Lu 177 vipivotide tetraxetan
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA215833
- Marketing category
- NDA
- Marketing start
- 2022-03-23
- Substance
- LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
- Active strength
- 27 mCi/mL
- Pharmacologic classes
- Radioligand Activity [MoA], Radioligand Therapeutic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PLUVICTO
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN | 27 mCi/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | G6UF363ECX |
| Rxcui | 2597057, 2597060 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 1813d81f-58b3-46f7-a4d5-e1c8faa90407 | Product name | 1 | 20230103 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0078-1217-61 | PLUVICTO | 7.5 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 7.5 | 3 | |
| 0078-1217-61 | PLUVICTO | 1 in 1 PACKAGE | INJECTION, SOLUTION | 1 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0078-1217-61 | EA - Each | 0078-1217 | eb44016b-abe1-4350-8e59-b04825f01a9e | 1 | 2026-02-05 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2597057 | lutetium Lu 177 vipivotide tetraxetan 1000 MBq/mL Injection | PSN | 14908037-2892-4d98-a053-253ce35afb1a | 3 |
| 2597060 | PLUVICTO 1000 MBq/mL (27 MCI/ML) Injection | PSN | 14908037-2892-4d98-a053-253ce35afb1a | 3 |
| 2597060 | 12.5 ML lutetium Lu 177 vipivotide tetraxetan 27 MCI/ML Injection [Pluvicto] | SBD | 14908037-2892-4d98-a053-253ce35afb1a | 3 |
| 2597057 | 12.5 ML lutetium Lu 177 vipivotide tetraxetan 27 MCI/ML Injection | SCD | 14908037-2892-4d98-a053-253ce35afb1a | 3 |
| 2597057 | lutetium Lu 177 vipivotide tetraxetan 200 mCi per 12.5 ML Injection | SY | 14908037-2892-4d98-a053-253ce35afb1a | 3 |
| 2597057 | lutetium Lu 177 vipivotide tetraxetan 7.4 GBq per 12.5 ML Injection | SY | 14908037-2892-4d98-a053-253ce35afb1a | 3 |
| 2597060 | Pluvicto 200 mCi per 12.5 ML Injection | SY | 14908037-2892-4d98-a053-253ce35afb1a | 3 |
| 2597060 | Pluvicto 7.4 GBq per 12.5 ML Injection | SY | 14908037-2892-4d98-a053-253ce35afb1a | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 0078-1217-61 | 00078121761 | 1 VIAL, GLASS in 1 PACKAGE (0078-1217-61) / 7.5 mL in 1 VIAL, GLASS | 2026-01-15 | No | No | Historical |