NDC 66658-112

Kepivance

Palifermin

Kepivance is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Swedish Orphan Biovitrum Ab (publ). The primary component is Palifermin.

• Product ID: 66658-112_23803d17-1142-4037-bc4f-5d643de9d329
• NDC: 66658-112
• Product Type: Human Prescription Drug
• Proprietary Name: Kepivance
• Generic Name: Palifermin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2009-12-15
• Marketing Category: BLA / BLA
• Application Number: BLA125103
• Labeler Name: Swedish Orphan Biovitrum AB (publ)
• Substance Name: PALIFERMIN
• Active Ingredient Strength: 6 mg/1.2mL
• Pharm Classes: Fibroblast Growth Factor 7 [CS],Increased Epithelial Proliferation [PE],Mucocutaneous Epithelial Cell Growth Factor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 66658-112-03

3 VIAL, SINGLE-USE in 1 CARTON (66658-112-03) > 1.2 mL in 1 VIAL, SINGLE-USE (66658-112-01)

• Marketing Start Date: 2009-12-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66658-112-01 [66658011201]

Kepivance INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125103
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-11-14

NDC 66658-112-03 [66658011203]

Kepivance INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125103
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-12-15

NDC 66658-112-24 [66658011224]

Kepivance INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125103
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-12-15
• Marketing End Date: 2016-04-01

NDC 66658-112-06 [66658011206]

Kepivance INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125103
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-12-15

Drug Details

Active Ingredients

Ingredient	Strength
PALIFERMIN	6.25 mg/1.2mL

OpenFDA Data

• SPL SET ID: 426f6e64-2c20-4a61-6d65-7320426f6e64
• Manufacturer:
  • Swedish Orphan Biovitrum AB (publ)
• UNII:
  • QMS40680K6
• RxNorm Concept Unique ID - RxCUI:
  • 545357
  • 486510

Pharmacological Class

• Fibroblast Growth Factor 7 [CS]
• Increased Epithelial Proliferation [PE]
• Mucocutaneous Epithelial Cell Growth Factor [EPC]