LYNOZYFIC
- Product NDC
- 61755-054
- 11-digit product format
- 617550054
- Labeler code
- 61755
- Product ID
- 61755-054_d82c287f-a94e-4831-9991-4742cdd17348
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- linvoseltamab-gcpt
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Regeneron Pharmaceuticals, Inc.
- Application
- BLA761400
- Marketing category
- BLA
- Marketing start
- 2025-07-02
- Substance
- LINVOSELTAMAB
- Active strength
- 5 mg/2.5mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LYNOZYFIC
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LINVOSELTAMAB | 5 mg/2.5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | M3CPC50MZS |
| Rxcui | 2719483, 2719490, 2719494, 2719497 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61755-054-00 | LYNOZYFIC | 2.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 2.5 | 6 | |
| 61755-054-01 | LYNOZYFIC | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61755-054-00 | ML - Milliliter | 61755-054 | db8a9aa5-1ec1-4b92-ae2c-034861e05169 | 1 | 2025-08-11 |
| 61755-054-01 | ML - Milliliter | 61755-054 | b5622ed0-2373-474c-96a9-c3ef07c8480b | 1 | 2025-08-11 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2719483 | linvoseltamab-gcpt 200 MG in 10 ML Injection | PSN | e9fd0739-1b3f-4b8b-824a-1f0a902384d3 | 6 |
| 2719494 | linvoseltamab-gcpt 5 MG in 2.5 ML Injection | PSN | e9fd0739-1b3f-4b8b-824a-1f0a902384d3 | 6 |
| 2719490 | LYNOZYFIC 200 MG in 10 ML Injection | PSN | e9fd0739-1b3f-4b8b-824a-1f0a902384d3 | 6 |
| 2719497 | LYNOZYFIC 5 MG in 2.5 ML Injection | PSN | e9fd0739-1b3f-4b8b-824a-1f0a902384d3 | 6 |
| 2719490 | 10 ML linvoseltamab-gcpt 20 MG/ML Injection [Lynozyfic] | SBD | e9fd0739-1b3f-4b8b-824a-1f0a902384d3 | 6 |
| 2719497 | 2.5 ML linvoseltamab-gcpt 2 MG/ML Injection [Lynozyfic] | SBD | e9fd0739-1b3f-4b8b-824a-1f0a902384d3 | 6 |
| 2719483 | 10 ML linvoseltamab-gcpt 20 MG/ML Injection | SCD | e9fd0739-1b3f-4b8b-824a-1f0a902384d3 | 6 |
| 2719494 | 2.5 ML linvoseltamab-gcpt 2 MG/ML Injection | SCD | e9fd0739-1b3f-4b8b-824a-1f0a902384d3 | 6 |
| 2719490 | 10 ML Lynozyfic 20 MG/ML Injection | SY | e9fd0739-1b3f-4b8b-824a-1f0a902384d3 | 6 |
| 2719497 | 2.5 ML Lynozyfic 2 MG/ML Injection | SY | e9fd0739-1b3f-4b8b-824a-1f0a902384d3 | 6 |
| 2719483 | linvoseltamab-gcpt 200 MG per 10 ML Injection | SY | e9fd0739-1b3f-4b8b-824a-1f0a902384d3 | 6 |
| 2719494 | linvoseltamab-gcpt 5 MG per 2.5 ML Injection | SY | e9fd0739-1b3f-4b8b-824a-1f0a902384d3 | 6 |
| 2719490 | Lynozyfic 200 MG per 10 ML Injection | SY | e9fd0739-1b3f-4b8b-824a-1f0a902384d3 | 6 |
| 2719497 | Lynozyfic 5 MG per 2.5 ML Injection | SY | e9fd0739-1b3f-4b8b-824a-1f0a902384d3 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61755-054-00 | 61755005400 | 2.5 mL in 1 VIAL, SINGLE-DOSE | 2.5 ml | Historical | |||
| 61755-054-01 | 61755005401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61755-054-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE (61755-054-00) | 2025-07-02 | No | No | Historical |