BioThrax
- Product NDC
- 64678-211
- 11-digit product format
- 646780211
- Labeler code
- 64678
- Product ID
- 64678-211_548ed5a0-4263-4c30-997d-24db0c078ddf
- Type
- VACCINE
- Nonproprietary name
- Anthrax Vaccine Adsorbed
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR; SUBCUTANEOUS
- Labeler
- Emergent BioDefense Operations Lansing, LLC
- Application
- BLA103821
- Marketing category
- BLA
- Marketing start
- 1970-11-04
- Substance
- BACILLUS ANTHRACIS STRAIN V770-NP1-R ANTIGENS
- Active strength
- 100 ug/mL
- Pharmacologic classes
- Actively Acquired Immunity [PE], Anthrax Vaccines [Chemical/Ingredient], Live Attenuated Bacillus Anthracis Vaccine [EPC], Vaccines, Attenuated [Chemical/Ingredient]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BioThrax
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BACILLUS ANTHRACIS STRAIN V770-NP1-R ANTIGENS | 100 ug/mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64678-211-01 | BioThrax | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 14 |
| 64678-211-05 | BioThrax | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SUSPENSION | 5 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BACILLUS ANTHRACIS STRAIN V770-NP1-R ANTIGENS | ACTIVE INGREDIENT | 873OI62848 | BIOTHRAX (BACILLUS ANTHRACIS) INJECTION, SUSPENSION [EMERGENT BIODEFENSE OPERATIONS LANSING, LLC] | 8 | |
| BACILLUS ANTHRACIS STRAIN V770-NP1-R ANTIGENS | ACTIVE MOIETY | 873OI62848 | BIOTHRAX (BACILLUS ANTHRACIS) INJECTION, SUSPENSION [EMERGENT BIODEFENSE OPERATIONS LANSING, LLC] | 8 | |
| ALUMINUM HYDROXIDE | INACTIVE INGREDIENT | 5QB0T2IUN0 | BIOTHRAX (BACILLUS ANTHRACIS) INJECTION, SUSPENSION [EMERGENT BIODEFENSE OPERATIONS LANSING, LLC] | 8 | |
| BENZETHONIUM CHLORIDE | INACTIVE INGREDIENT | PH41D05744 | BIOTHRAX (BACILLUS ANTHRACIS) INJECTION, SUSPENSION [EMERGENT BIODEFENSE OPERATIONS LANSING, LLC] | 8 | |
| FORMALDEHYDE | INACTIVE INGREDIENT | 1HG84L3525 | BIOTHRAX (BACILLUS ANTHRACIS) INJECTION, SUSPENSION [EMERGENT BIODEFENSE OPERATIONS LANSING, LLC] | 8 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | BIOTHRAX (BACILLUS ANTHRACIS) INJECTION, SUSPENSION [EMERGENT BIODEFENSE OPERATIONS LANSING, LLC] | 8 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BIOTHRAX (BACILLUS ANTHRACIS) INJECTION, SUSPENSION [EMERGENT BIODEFENSE OPERATIONS LANSING, LLC] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64678-211 | BIOTHRAX (ANTHRAX VACCINE ADSORBED) INJECTION, SUSPENSION [EMERGENT BIODEFENSE OPERATIONS LANSING, LLC] | 12 | Current NDC, Legacy NDC, 2 package rows | 20250511_e0b11800-8922-11df-b3d7-0002a5d5c51b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64678-211-01 | 64678021101 | 1 VIAL, MULTI-DOSE in 1 CARTON (64678-211-01) / 5 mL in 1 VIAL, MULTI-DOSE (64678-211-05) | | 1970-11-04 | 0000-00-00 | No | No | Current |
| 64678-211-05 | 64678021105 | 5 mL in 1 VIAL, MULTI-DOSE | 5 ml | | | | | Historical |