Kepivance
- Product NDC
- 66658-112
- 11-digit product format
- 666580112
- Labeler code
- 66658
- Product ID
- 66658-112_23803d17-1142-4037-bc4f-5d643de9d329
- 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
- 2009-12-15
- Marketing end
- 0000-00-00
- Substance
- PALIFERMIN
- Active strength
- 6 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 66658-112-03 | 66658011203 | 3 VIAL, SINGLE-USE in 1 CARTON (66658-112-03) > 1.2 mL in 1 VIAL, SINGLE-USE (66658-112-01) | 2009-12-15 | 0000-00-00 | No | No | Current |
| 66658-112-06 | 66658011206 | 6 VIAL, SINGLE-USE in 1 CARTON (66658-112-06) > 1.2 mL in 1 VIAL, SINGLE-USE (66658-112-01) | 2009-12-15 | 0000-00-00 | No | No | Current |