ANDEMBRY
- Product NDC
- 63833-925
- 11-digit product format
- 638330925
- Labeler code
- 63833
- Product ID
- 63833-925_a15c0e04-117a-434d-8b34-b664701b787f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Garadacimab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- CSL
- Application
- BLA761367
- Marketing category
- BLA
- Marketing start
- 2025-06-16
- Substance
- GARADACIMAB
- Active strength
- 200 mg/1.2mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ANDEMBRY
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GARADACIMAB | 200 mg/1.2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 32W6AJL0DY |
| Rxcui | 2717175, 2717182 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63833-925-01 | ANDEMBRY | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
| 63833-925-20 | ANDEMBRY | 1.2 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 1.2 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63833-925-01 | 63833092501 | 1 SYRINGE, GLASS in 1 CARTON (63833-925-01) / 1.2 mL in 1 SYRINGE, GLASS (63833-925-20) | | 2025-06-16 | No | No | Historical |
| 63833-925-20 | 63833092520 | 1.2 mL in 1 SYRINGE, GLASS | 1.2 ml | | | | Historical |