Raxibacumab
- Product NDC
- 71655-103
- 11-digit product format
- 716550103
- Labeler code
- 71655
- Product ID
- 71655-103_867ea1a9-2710-483d-a9ef-5b1d6a579f3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- raxibacumab
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Emergent Manufacturing Operations Baltimore LLC
- Application
- BLA125349
- Marketing category
- BLA
- Marketing start
- 2012-12-14
- Substance
- RAXIBACUMAB
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Anthrax Protective Antigen-directed Antibody Interactions [MoA], Anthrax Protective Antigen-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
- Raxibacumab
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RAXIBACUMAB | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 794PGL549S |
| Rxcui | 1366571 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71655-103-01 | Raxibacumab | 1 in 1 CARTON | INJECTION | 1 | | 4 |
| 71655-103-01 | Raxibacumab | 34 mL in 1 VIAL, SINGLE-USE | INJECTION | 34 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71655-103 | RAXIBACUMAB INJECTION [EMERGENT MANUFACTURING OPERATIONS BALTIMORE LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250112_f6927e91-bb46-47b3-ab66-f9d8a9d7b12a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71655-103-01 | 71655010301 | 1 VIAL, SINGLE-USE in 1 CARTON (71655-103-01) / 34 mL in 1 VIAL, SINGLE-USE | 2012-12-14 | 0000-00-00 | No | No | Current |