SOGROYA
- Product NDC
- 0169-2030
- 11-digit product format
- 001692030
- Labeler code
- 0169
- Product ID
- 0169-2030_02935ecf-5395-4b9b-9b2f-75d59ca651f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- somapacitan-beco
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Novo Nordisk
- Application
- BLA761156
- Marketing category
- BLA
- Marketing start
- 2023-05-01
- Substance
- SOMAPACITAN
- Active strength
- 6.7 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SOGROYA
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SOMAPACITAN | 6.7 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 8FOJ430U94 |
| Rxcui | 2557398, 2557403, 2571802, 2571805, 2636951, 2636954 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3db24f33-28f1-4bf1-b5d1-be169942b92a | Product name | 3 | 20240507 |
| 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 |
|---|---|---|---|---|---|---|
| 0169-2030-11 | SOGROYA | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 8 | |
| 0169-2030-11 | SOGROYA | 1.5 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 1.5 | 8 | |
| 0169-2030-90 | SOGROYA | 1.5 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 1.5 | 8 | |
| 0169-2030-90 | SOGROYA | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0169-2030-11 | ML - Milliliter | 0169-2030 | 376a3cc2-f74d-4ec9-ab87-1be15ff6dff7 | 1 | 2023-06-06 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2557403 | Sogroya 10 MG in 1.5 ML Pen Injector | PSN | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2636954 | Sogroya 15 MG in 1.5 ML Pen Injector | PSN | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2571805 | Sogroya 5 MG in 1.5 ML Pen Injector | PSN | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2557398 | somapacitan-beco 10 MG in 1.5 ML Pen Injector | PSN | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2636951 | somapacitan-beco 15 MG in 1.5 ML Pen Injector | PSN | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2571802 | somapacitan-beco 5 MG in 1.5 ML Pen Injector | PSN | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2636954 | 1.5 ML somapacitan-beco 10 MG/ML Pen Injector [Sogroya] | SBD | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2571805 | 1.5 ML somapacitan-beco 3.3 MG/ML Pen Injector [Sogroya] | SBD | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2557403 | 1.5 ML somapacitan-beco 6.7 MG/ML Pen Injector [Sogroya] | SBD | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2636951 | 1.5 ML somapacitan-beco 10 MG/ML Pen Injector | SCD | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2571802 | 1.5 ML somapacitan-beco 3.3 MG/ML Pen Injector | SCD | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2557398 | 1.5 ML somapacitan-beco 6.7 MG/ML Pen Injector | SCD | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2636954 | 1.5 ML Sogroya 10 MG/ML Pen Injector | SY | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2557403 | 1.5 ML Sogroya 6.7 MG/ML Pen Injector | SY | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2557403 | Sogroya 10 MG per 1.5 ML Pen Injector | SY | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2636954 | Sogroya 15 MG per 1.5 ML Pen Injector | SY | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2571805 | Sogroya 3.3 MG/ML per 1.5 ML Pen Injector | SY | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2571805 | Sogroya 5 MG per 1.5 ML Pen Injector | SY | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2636951 | somapacitan-beco 15 MG per 1.5 ML Pen Injector | SY | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2571802 | somapacitan-beco 3.3 MG/ML per 1.5 ML Pen Injector | SY | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
| 2571802 | somapacitan-beco 5 MG per 1.5 ML Pen Injector | SY | eadd03b4-adc3-4b88-8a24-9d205c5b85aa | 8 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0169-2030-11 | 00169203011 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-2030-11) / 1.5 mL in 1 SYRINGE, PLASTIC | 2023-05-01 | 0000-00-00 | No | No | Current |
| 0169-2030-90 | 00169203090 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-2030-90) / 1.5 mL in 1 SYRINGE, PLASTIC | 2023-05-01 | 0000-00-00 | No | No | Current |