Loargys
- Product NDC
- 81583-102
- 11-digit product format
- 815830102
- Labeler code
- 81583
- Product ID
- 81583-102_d5ceabf2-43a0-4746-9371-d98a39cf6cfc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pegzilarginase-nbln
- Dosage form
- INJECTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Immedica Pharma US Inc.
- Application
- BLA761211
- Marketing category
- BLA
- Marketing start
- 2026-03-09
- Substance
- PEGZILARGINASE
- Active strength
- 2 mg/.4mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Loargys
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PEGZILARGINASE | 2 mg/.4mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 4YV4KW88GD |
| Rxcui | 2738655, 2738662, 2738664, 2738665 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| efd58dcf-540a-4531-8766-e713129ca6f2 | Product name | 1 | 20250307 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81583-102-01 | Loargys | 1 in 1 CARTON | INJECTION | 1 | 1 | |
| 81583-102-01 | Loargys | 0.4 mL in 1 VIAL | INJECTION | 0.4 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2738665 | Loargys 2 MG in 0.4 ML Injection | PSN | d5ceabf2-43a0-4746-9371-d98a39cf6cfc | 1 |
| 2738662 | Loargys 5 MG in 1 ML Injection | PSN | d5ceabf2-43a0-4746-9371-d98a39cf6cfc | 1 |
| 2738664 | pegzilarginase-nbln 2 MG in 0.4 ML Injection | PSN | d5ceabf2-43a0-4746-9371-d98a39cf6cfc | 1 |
| 2738655 | pegzilarginase-nbln 5 MG in 1 ML Injection | PSN | d5ceabf2-43a0-4746-9371-d98a39cf6cfc | 1 |
| 2738665 | 0.4 ML pegzilarginase-nbln 5 MG/ML Injection [Loargys] | SBD | d5ceabf2-43a0-4746-9371-d98a39cf6cfc | 1 |
| 2738662 | 1 ML pegzilarginase-nbln 5 MG/ML Injection [Loargys] | SBD | d5ceabf2-43a0-4746-9371-d98a39cf6cfc | 1 |
| 2738664 | 0.4 ML pegzilarginase-nbln 5 MG/ML Injection | SCD | d5ceabf2-43a0-4746-9371-d98a39cf6cfc | 1 |
| 2738655 | 1 ML pegzilarginase-nbln 5 MG/ML Injection | SCD | d5ceabf2-43a0-4746-9371-d98a39cf6cfc | 1 |
| 2738665 | Loargys 2 MG per 0.4 ML Injection | SY | d5ceabf2-43a0-4746-9371-d98a39cf6cfc | 1 |
| 2738662 | Loargys 5 MG per 1 ML Injection | SY | d5ceabf2-43a0-4746-9371-d98a39cf6cfc | 1 |
| 2738665 | Loargys 5 MG/ML per 0.4 ML Injection | SY | d5ceabf2-43a0-4746-9371-d98a39cf6cfc | 1 |
| 2738662 | Loargys 5 MG/ML per 1 ML Injection | SY | d5ceabf2-43a0-4746-9371-d98a39cf6cfc | 1 |
| 2738664 | pegzilarginase-nbln 2 MG per 0.4 ML Injection | SY | d5ceabf2-43a0-4746-9371-d98a39cf6cfc | 1 |
| 2738655 | pegzilarginase-nbln 5 MG per 1 ML Injection | SY | d5ceabf2-43a0-4746-9371-d98a39cf6cfc | 1 |
| 2738664 | pegzilarginase-nbln 5 MG/ML per 0.4 ML Injection | SY | d5ceabf2-43a0-4746-9371-d98a39cf6cfc | 1 |
| 2738655 | pegzilarginase-nbln 5 MG/ML per 1 ML Injection | SY | d5ceabf2-43a0-4746-9371-d98a39cf6cfc | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 81583-102-01 | 81583010201 | 1 VIAL in 1 CARTON (81583-102-01) / .4 mL in 1 VIAL | 1 vial | 2026-03-09 | No | No | Current |