TALVEY
- Product NDC
- 57894-470
- 11-digit product format
- 578940470
- Labeler code
- 57894
- Product ID
- 57894-470_40aadf9f-8468-bd68-e063-6394a90a32a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- talquetamab
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Janssen Biotech, Inc.
- Application
- BLA761342
- Marketing category
- BLA
- Marketing start
- 2023-08-09
- Substance
- TALQUETAMAB
- Active strength
- 40 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TALVEY
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TALQUETAMAB | 40 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 4W3KFI3TN3 |
| Rxcui | 2644452, 2644458, 2644461, 2644464 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2775fd8-872b-4f90-a0a1-0413a682ca35 | Product name | 1 | 20240909 |
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 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 |
|---|---|---|---|---|---|---|
| 57894-470-01 | TALVEY | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | 5 | |
| 57894-470-01 | TALVEY | 1 in 1 CARTON | INJECTION | 1 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57894-470-01 | ML - Milliliter | 57894-470 | 037634c6-5abc-42fb-af3e-08e1d8aacfb0 | 1 | 2023-09-05 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2644452 | talquetamab-tgvs 3 MG in 1.5 ML Injection | PSN | 9001355e-003d-4d4e-b4ce-337e0fd14952 | 5 |
| 2644461 | talquetamab-tgvs 40 MG in 1 ML Injection | PSN | 9001355e-003d-4d4e-b4ce-337e0fd14952 | 5 |
| 2644458 | Talvey 3 MG in 1.5 ML Injection | PSN | 9001355e-003d-4d4e-b4ce-337e0fd14952 | 5 |
| 2644464 | Talvey 40 MG in 1 ML Injection | PSN | 9001355e-003d-4d4e-b4ce-337e0fd14952 | 5 |
| 2644464 | 1 ML talquetamab-tgvs 40 MG/ML Injection [Talvey] | SBD | 9001355e-003d-4d4e-b4ce-337e0fd14952 | 5 |
| 2644458 | 1.5 ML talquetamab-tgvs 2 MG/ML Injection [Talvey] | SBD | 9001355e-003d-4d4e-b4ce-337e0fd14952 | 5 |
| 2644461 | 1 ML talquetamab-tgvs 40 MG/ML Injection | SCD | 9001355e-003d-4d4e-b4ce-337e0fd14952 | 5 |
| 2644452 | 1.5 ML talquetamab-tgvs 2 MG/ML Injection | SCD | 9001355e-003d-4d4e-b4ce-337e0fd14952 | 5 |
| 2644464 | 1 ML Talvey 40 MG/ML Injection | SY | 9001355e-003d-4d4e-b4ce-337e0fd14952 | 5 |
| 2644458 | 1.5 ML Talvey 2 MG/ML Injection | SY | 9001355e-003d-4d4e-b4ce-337e0fd14952 | 5 |
| 2644452 | talquetamab-tgvs 3 MG per 1.5 ML Injection | SY | 9001355e-003d-4d4e-b4ce-337e0fd14952 | 5 |
| 2644461 | talquetamab-tgvs 40 MG per 1 ML Injection | SY | 9001355e-003d-4d4e-b4ce-337e0fd14952 | 5 |
| 2644458 | Talvey 3 MG per 1.5 ML Injection | SY | 9001355e-003d-4d4e-b4ce-337e0fd14952 | 5 |
| 2644464 | Talvey 40 MG per 1 ML Injection | SY | 9001355e-003d-4d4e-b4ce-337e0fd14952 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 57894-470-01 | 57894047001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-470-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 2023-08-09 | No | No | Current |