Kalbitor
- Product NDC
- 47783-101
- 11-digit product format
- 477830101
- Labeler code
- 47783
- Product ID
- 47783-101_1992039f-246f-4057-899b-987d45df152f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ecallantide
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- BLA125277
- Marketing category
- BLA
- Marketing start
- 2010-02-02
- Substance
- ECALLANTIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Kallikrein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47783-101-01 | Kalbitor | 3 in 1 CARTON | INJECTION, SOLUTION | 3 | | 19 |
| 47783-101-01 | Kalbitor | 1 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 1 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ECALLANTIDE | ACTIVE INGREDIENT | 5Q6TZN2HNM | KALBITOR (ECALLANTIDE) INJECTION, SOLUTION [DYAX CORP.] | 10 | |
| ECALLANTIDE | ACTIVE MOIETY | 5Q6TZN2HNM | KALBITOR (ECALLANTIDE) INJECTION, SOLUTION [DYAX CORP.] | 10 | |
| POTASSIUM CHLORIDE | INACTIVE INGREDIENT | 660YQ98I10 | KALBITOR (ECALLANTIDE) INJECTION, SOLUTION [DYAX CORP.] | 10 | |
| POTASSIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 4J9FJ0HL51 | KALBITOR (ECALLANTIDE) INJECTION, SOLUTION [DYAX CORP.] | 10 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | KALBITOR (ECALLANTIDE) INJECTION, SOLUTION [DYAX CORP.] | 10 | |
| SODIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | 94255I6E2T | KALBITOR (ECALLANTIDE) INJECTION, SOLUTION [DYAX CORP.] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47783-101 | KALBITOR (ECALLANTIDE) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 18 | Current NDC, Legacy NDC, 2 package rows | 20231222_f56aec67-c662-477c-b866-bfc23e8809cf.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 |
|---|
| 47783-101-01 | 47783010101 | 3 VIAL, GLASS in 1 CARTON (47783-101-01) / 1 mL in 1 VIAL, GLASS | 2010-02-02 | 0000-00-00 | No | No | Current |