KEPIVANCE
- Product NDC
- 66658-113
- 11-digit product format
- 666580113
- Labeler code
- 66658
- Product ID
- 66658-113_462812de-e664-609f-e063-6294a90a1e3d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- palifermin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Swedish Orphan Biovitrum AB (publ)
- Application
- BLA125103
- Marketing category
- BLA
- Marketing start
- 2023-08-04
- Substance
- PALIFERMIN
- Active strength
- 5.16 mg/1.2mL
- Pharmacologic classes
- Fibroblast Growth Factor 7 [CS], Increased Epithelial Proliferation [PE], Mucocutaneous Epithelial Cell Growth Factor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| QMS40680K6 | PALIFERMIN | 162394-19-6 | PALIFERMIN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 66658-113-03 | 66658011303 | 3 VIAL, SINGLE-USE in 1 CARTON (66658-113-03) / 1.2 mL in 1 VIAL, SINGLE-USE (66658-113-01) | 2023-08-04 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| KEPIVANCE | Swedish Orphan Biovitrum AB (publ) | 2025-12-17 | HUMAN PRESCRIPTION DRUG LABEL | 22 |