CYFENDUS
- Product NDC
- 71665-001
- 11-digit product format
- 716650001
- Labeler code
- 71665
- Product ID
- 71665-001_9b987e1d-cdc5-4ecb-a61c-153549194065
- Type
- VACCINE
- Nonproprietary name
- Anthrax Vaccine Adsorbed, Adjuvanted
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- Emergent Product Development Gaithersburg Inc.
- Application
- BLA125761
- Marketing category
- BLA
- Marketing start
- 2023-09-19
- 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
- CYFENDUS
- 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 |
|---|
| 71665-001-01 | CYFENDUS | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SUSPENSION | 5 | | 6 |
| 71665-001-02 | CYFENDUS | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71665-001 | CYFENDUS (ANTHRAX VACCINE ADSORBED, ADJUVANTED) INJECTION, SUSPENSION [EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.] | 4 | Current NDC, 2 package rows | 20250511_d4f29180-7c76-40ac-9341-cf62702c4090.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 |
|---|
| 71665-001-01 | 71665000101 | 5 mL in 1 VIAL, MULTI-DOSE | 5 ml | | | | Historical |
| 71665-001-02 | 71665000102 | 1 VIAL, MULTI-DOSE in 1 CARTON (71665-001-02) / 5 mL in 1 VIAL, MULTI-DOSE (71665-001-01) | | 2023-09-19 | No | No | Historical |