RYSTIGGO
- Product NDC
- 50474-981
- 11-digit product format
- 504740981
- Labeler code
- 50474
- Product ID
- 50474-981_48d5f5c1-c45c-cb63-e063-6394a90a31c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROZANOLIXIZUMAB
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- UCB, Inc.
- Application
- BLA761286
- Marketing category
- BLA
- Marketing start
- 2024-06-14
- Substance
- ROZANOLIXIZUMAB
- Active strength
- 140 mg/mL
- Pharmacologic classes
- Neonatal Fc Receptor Blocker [EPC], Neonatal Fc Receptor Blockers [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RYSTIGGO
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ROZANOLIXIZUMAB | 140 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | P7186074QC |
| Rxcui | 2642288, 2642294, 2685614, 2685615, 2685616, 2685617, 2685618, 2685619 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 27acca31-f9bf-4551-a3a7-821bf95dbf74 | Product name | 1 | 20231030 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50474-981-83 | RYSTIGGO | 3 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 3 | 10 | |
| 50474-981-83 | RYSTIGGO | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50474-981-83 | ML - Milliliter | 50474-981 | 098b33e6-bea8-4d62-876a-b87c812d408e | 1 | 2024-07-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2642288 | rozanolixizumab-noli 280 MG in 2 ML Injection | PSN | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685614 | rozanolixizumab-noli 420 MG in 3 ML Injection | PSN | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685616 | rozanolixizumab-noli 560 MG in 4 ML Injection | PSN | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685618 | rozanolixizumab-noli 840 MG in 6 ML Injection | PSN | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2642294 | RYSTIGGO 280 MG in 2 ML Injection | PSN | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685615 | RYSTIGGO 420 MG in 3 ML Injection | PSN | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685617 | RYSTIGGO 560 MG in 4 ML Injection | PSN | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685619 | RYSTIGGO 840 MG in 6 ML Injection | PSN | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2642294 | 2 ML rozanolixizumab-noli 140 MG/ML Injection [Rystiggo] | SBD | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685615 | 3 ML rozanolixizumab-noli 140 MG/ML Injection [Rystiggo] | SBD | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685617 | 4 ML rozanolixizumab-noli 140 MG/ML Injection [Rystiggo] | SBD | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685619 | 6 ML rozanolixizumab-noli 140 MG/ML Injection [Rystiggo] | SBD | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2642288 | 2 ML rozanolixizumab-noli 140 MG/ML Injection | SCD | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685614 | 3 ML rozanolixizumab-noli 140 MG/ML Injection | SCD | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685616 | 4 ML rozanolixizumab-noli 140 MG/ML Injection | SCD | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685618 | 6 ML rozanolixizumab-noli 140 MG/ML Injection | SCD | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2642294 | 2 ML Rystiggo 140 MG/ML Injection | SY | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2642288 | rozanolixizumab-noli 280 MG per 2 ML Injection | SY | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685614 | rozanolixizumab-noli 420 MG per 3 ML Injection | SY | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685616 | rozanolixizumab-noli 560 MG per 4 ML Injection | SY | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685618 | rozanolixizumab-noli 840 MG per 6 ML Injection | SY | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2642294 | Rystiggo 280 MG per 2 ML Injection | SY | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685615 | Rystiggo 420 MG per 3 ML Injection | SY | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685617 | Rystiggo 560 MG per 4 ML Injection | SY | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
| 2685619 | Rystiggo 840 MG per 6 ML Injection | SY | 3c0eb8c2-c042-4954-b451-3baa77f5e6d1 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 50474-981-83 | 50474098183 | 1 VIAL, GLASS in 1 CARTON (50474-981-83) / 3 mL in 1 VIAL, GLASS | 2024-07-15 | No | No | Current |