kepivance

Generic: palifermin

Labeler: swedish orphan biovitrum ab (publ)
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name kepivance
Generic Name palifermin
Labeler swedish orphan biovitrum ab (publ)
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

palifermin 5.16 mg/1.2mL

Manufacturer
Swedish Orphan Biovitrum AB (publ)

Identifiers & Regulatory

Product NDC 66658-113
Product ID 66658-113_462812de-e664-609f-e063-6294a90a1e3d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125103
Listing Expiration 2026-12-31
Marketing Start 2023-08-04

Pharmacologic Class

Established (EPC)
mucocutaneous epithelial cell growth factor [epc]
Chemical Structure
fibroblast growth factor 7 [cs]
Physiologic Effect
increased epithelial proliferation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66658113
Hyphenated Format 66658-113

Supplemental Identifiers

RxCUI
2643434 2643436
UNII
QMS40680K6
NUI
M0168688 N0000175675 N0000175671

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name kepivance (source: ndc)
Generic Name palifermin (source: ndc)
Application Number BLA125103 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5.16 mg/1.2mL
source: ndc
Packaging
  • 3 VIAL, SINGLE-USE in 1 CARTON (66658-113-03) / 1.2 mL in 1 VIAL, SINGLE-USE (66658-113-01)
source: ndc

Packages (1)

66658-113-03 3 VIAL, SINGLE-USE in 1 CARTON (66658-113-03) / 1.2 mL in 1 VIAL, SINGLE-USE (66658-113-01)

Ingredients (1)

palifermin (5.16 mg/1.2mL)

Linked Drug Pages (1)

KEPIVANCE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "462812de-e664-609f-e063-6294a90a1e3d", "openfda": {"nui": ["M0168688", "N0000175675", "N0000175671"], "unii": ["QMS40680K6"], "rxcui": ["2643434", "2643436"], "spl_set_id": ["426f6e64-2c20-4a61-6d65-7320426f6e64"], "pharm_class_cs": ["Fibroblast Growth Factor 7 [CS]"], "pharm_class_pe": ["Increased Epithelial Proliferation [PE]"], "pharm_class_epc": ["Mucocutaneous Epithelial Cell Growth Factor [EPC]"], "manufacturer_name": ["Swedish Orphan Biovitrum AB (publ)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 VIAL, SINGLE-USE in 1 CARTON (66658-113-03)  / 1.2 mL in 1 VIAL, SINGLE-USE (66658-113-01)", "package_ndc": "66658-113-03", "marketing_start_date": "20230804"}], "brand_name": "KEPIVANCE", "product_id": "66658-113_462812de-e664-609f-e063-6294a90a1e3d", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Fibroblast Growth Factor 7 [CS]", "Increased Epithelial Proliferation [PE]", "Mucocutaneous Epithelial Cell Growth Factor [EPC]"], "product_ndc": "66658-113", "generic_name": "palifermin", "labeler_name": "Swedish Orphan Biovitrum AB (publ)", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KEPIVANCE", "active_ingredients": [{"name": "PALIFERMIN", "strength": "5.16 mg/1.2mL"}], "application_number": "BLA125103", "marketing_category": "BLA", "marketing_start_date": "20230804", "listing_expiration_date": "20261231"}