Home NDC 66658-113 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base KEPIVANCE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PALIFERMIN 5.16 mg/1.2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QMS40680K6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2643434 Internal RxNorm lookup 2643436 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66658-113-01 KEPIVANCE 1.2 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 1.2 22 66658-113-03 KEPIVANCE 3 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 3 22
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded palifermin ACTIVE INGREDIENT QMS40680K6 KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] 10 palifermin ACTIVE MOIETY QMS40680K6 KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] 10 histidine INACTIVE INGREDIENT 4QD397987E KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] 10 mannitol INACTIVE INGREDIENT 3OWL53L36A KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] 10 polysorbate 20 INACTIVE INGREDIENT 7T1F30V5YH KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] 10 sucrose INACTIVE INGREDIENT C151H8M554 KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66658-113 KEPIVANCE (PALIFERMIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] 21 Current NDC, 2 package rows 20241222_426f6e64-2c20-4a61-6d65-7320426f6e64.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125103 Kepivance palifermin 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 66658-113-01 66658011301 1.2 mL in 1 VIAL, SINGLE-USE 1.2 ml Historical 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 Current