FASENRA
- Product NDC
- 0310-1730
- 11-digit product format
- 003101730
- Labeler code
- 0310
- Product ID
- 0310-1730_b78fbf2b-888c-41e2-bdab-cb5cd1ebb8fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benralizumab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- BLA761070
- Marketing category
- BLA
- Marketing start
- 2017-11-14
- Substance
- BENRALIZUMAB
- Active strength
- 30 mg/mL
- Pharmacologic classes
- Interleukin 5 Receptor alpha-directed Antibody Interactions [MoA], Interleukin-5 Receptor alpha-directed Cytolytic Antibody [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FASENRA
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENRALIZUMAB | 30 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 71492GE1FX |
| Rxcui | 1989104, 1989109, 2205632, 2205634, 2679499, 2679502 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| acf12302-28d3-4d82-826e-7927090aa64d | Product name | 1 | 20180110 |
| 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 |
|---|---|---|---|---|---|---|
| 0310-1730-30 | FASENRA | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 27 | |
| 0310-1730-30 | FASENRA | 1 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 1 | 27 | |
| 0310-1730-85 | FASENRA | 1 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 1 | 27 | |
| 0310-1730-85 | FASENRA | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 27 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0310-1730-30 | ML - Milliliter | 0310-1730 | 5806568b-604f-43ac-ba0e-3dab9e4e731e | 1 | 2017-12-14 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2679499 | benralizumab 10 MG in 0.5 ML Prefilled Syringe | PSN | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 2205632 | benralizumab 30 MG in 1 mL Auto-Injector | PSN | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 1989104 | benralizumab 30 MG in 1 ML Prefilled Syringe | PSN | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 2679502 | Fasenra 10 MG in 0.5 ML Prefilled Syringe | PSN | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 2205634 | Fasenra 30 MG in 1 mL Auto-Injector | PSN | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 1989109 | Fasenra 30 MG in 1 ML Prefilled Syringe | PSN | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 2679502 | 0.5 ML benralizumab 20 MG/ML Prefilled Syringe [Fasenra] | SBD | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 2205634 | 1 ML benralizumab 30 MG/ML Auto-Injector [Fasenra] | SBD | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 1989109 | 1 ML benralizumab 30 MG/ML Prefilled Syringe [Fasenra] | SBD | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 2679499 | 0.5 ML benralizumab 20 MG/ML Prefilled Syringe | SCD | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 2205632 | 1 ML benralizumab 30 MG/ML Auto-Injector | SCD | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 1989104 | 1 ML benralizumab 30 MG/ML Prefilled Syringe | SCD | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 2679502 | 0.5 ML Fasenra 20 MG/ML Prefilled Syringe | SY | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 2205634 | 1 ML Fasenra 30 MG/ML Auto-Injector | SY | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 1989109 | 1 ML Fasenra 30 MG/ML Prefilled Syringe | SY | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 2679499 | benralizumab 10 MG per 0.5 ML Prefilled Syringe | SY | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 2205632 | benralizumab 30 MG per 1 ML Auto-Injector | SY | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 1989104 | benralizumab 30 MG per 1 ML Prefilled Syringe | SY | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 2679502 | Fasenra 10 MG per 0.5 ML Prefilled Syringe | SY | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 2205634 | Fasenra 30 MG per 1 ML Auto-Injector | SY | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
| 1989109 | Fasenra 30 MG per 1 ML Prefilled Syringe | SY | da6aca1a-19ed-44a4-abb7-696c7d58b784 | 27 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0310-1730-30 | 00310173030 | 1 SYRINGE, GLASS in 1 CARTON (0310-1730-30) / 1 mL in 1 SYRINGE, GLASS | 2017-11-14 | 0000-00-00 | No | No | Current |
| 0310-1730-85 | 00310173085 | 1 SYRINGE, GLASS in 1 CARTON (0310-1730-85) / 1 mL in 1 SYRINGE, GLASS | 2017-11-14 | 0000-00-00 | Yes | No | Current |