FDA.reportPublic FDA data

Kepivance

Product NDC
66658-112
Requested package NDC
66658-112-03
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage66658-11266658-112-03DDiscontinued by firm2026-08-17

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66658-112-01EA - Each66658-1128e662888-3652-4e21-bf83-e2d1b055340c12013-02-13
66658-112-03EA - Each66658-112833670be-d969-416e-9939-047f98c26b4c12012-07-24
66658-112-06EA - Each66658-112e86d693e-4c82-4407-8f08-e5434c6a8a9412012-07-24

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KEPIVANCEPALIFERMINSwedish Orphan Biovitrum AB (publ)426f6e64-2c20-4a61-6d65-7320426f6e642025-12-17Warnings, Adverse reactionsExact identifier
application number: BLA125103

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125103Kepivancepalifermin351(a)Rx2026-07-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66658-112-03666580112033 VIAL, SINGLE-USE in 1 CARTON (66658-112-03) > 1.2 mL in 1 VIAL, SINGLE-USE (66658-112-01) 2009-12-150000-00-00NoNoCurrent