Raxibacumab
- Product NDC
- 71655-103
- 11-digit product format
- 716550103
- Labeler code
- 71655
- Product ID
- 71655-103_5b24ce09-93c6-115b-e063-6394a90aa9f2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- raxibacumab
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Emergent BioDefense Operations Lansing
- 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
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
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 |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125349 | | raxibacumab | 351(a) | Rx | 2026-09-01 |
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 |