Ebanga
- Product NDC
- 71655-578
- 11-digit product format
- 716550578
- Labeler code
- 71655
- Product ID
- 71655-578_cd0fd8d1-d716-4b80-ab41-1e524ed11072
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ansuvimab
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Emergent Manufacturing Operations Baltimore, LLC
- Application
- BLA761172
- Marketing category
- BLA
- Marketing start
- 2020-12-21
- Substance
- ANSUVIMAB
- Active strength
- 400 mg/8mL
- Pharmacologic classes
- Zaire Ebolavirus Glycoprotein-directed Antibody Interactions [MoA], Zaire Ebolavirus Glycoprotein-directed 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
- Ebanga
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ANSUVIMAB | 400 mg/8mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TG8IQ19NG2 |
| Rxcui | 2472156, 2472161 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71655-578-01 | Ebanga | 8 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 8 | | 2 |
| 71655-578-02 | Ebanga | 36 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 36 | | 2 |
| 71655-578-03 | Ebanga | 1 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 71655-578-04 | Ebanga | 4 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 4 | | 2 |
| 71655-578-08 | Ebanga | 8 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 8 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71655-578 | EBANGA (ANSUVIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EMERGENT MANUFACTURING OPERATIONS BALTIMORE, LLC] | 1 | Current NDC, 5 package rows | 20250117_de220c8f-ffcb-4522-a6a2-c7d6ce5de1b5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71655-578-01 | 71655057801 | 8 mL in 1 VIAL, GLASS | 8 ml | | | | Historical |
| 71655-578-02 | 71655057802 | 36 in 1 CARTON | | | | | Historical |
| 71655-578-03 | 71655057803 | 1 CARTON in 1 BOX (71655-578-03) / 36 VIAL, GLASS in 1 CARTON (71655-578-02) / 8 mL in 1 VIAL, GLASS (71655-578-01) | 1 carton | 2020-12-21 | No | No | Historical |
| 71655-578-04 | 71655057804 | 4 CARTON in 1 BOX (71655-578-04) / 36 VIAL, GLASS in 1 CARTON (71655-578-02) / 8 mL in 1 VIAL, GLASS (71655-578-01) | 4 carton | 2020-12-21 | No | No | Historical |
| 71655-578-08 | 71655057808 | 8 CARTON in 1 BOX (71655-578-08) / 36 VIAL, GLASS in 1 CARTON (71655-578-02) / 8 mL in 1 VIAL, GLASS (71655-578-01) | 8 carton | 2020-12-21 | No | No | Historical |