Kepivance palifermin 6.25 mg/1.2mL Injection, Powder, Lyophilized, For Solution, 6 vials
by Swedish Orphan Biovitrum AB (publ) · 6 VIAL, SINGLE-USE in 1 CARTON (66658-112-06) / 1.2 mL in 1 VIAL, SINGLE-USE (66658-112-01)
NDC 66658-0112-06
🏷️ FDA NDC (as labeled)
66658-112-06
billing pads the product segment with a zero
This package
Contains6 vials
Pack sizes2 compare ↓
Also comes in:
3 vials 66658-0112-03
Rx only
Brand
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
66658-112-06
Product NDC
66658-112
11-digit billing NDC
66658011206
NCPDP billing unit
EA — each (per item)
Application #
BLA125103
Established class (EPC)
Fibroblast Growth Factor 7 [CS], Increased Epithelial Proliferation [PE], Mucocutaneous Epithelial Cell Growth Factor
DEA schedule
Non-controlled
Marketing category
BLA
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Dec 2024)
Route
INTRAVENOUS
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance
PALIFERMIN
GCN Seq No
058485
GCN
23928
HICL code
026792
Ingredient (HICL)
Palifermin
HIC1 code
L
Therapeutic class — broad (HIC1)
Skin/Subcutaneous Tissue
HIC2 code
L5
Therapeutic class — intermediate (HIC2)
Keratolytics/Keratoplastics
HIC3 code
L5M
Therapeutic class — specific (HIC3)
Keratinocyte Growth Factor (Kgf)
AHFS code
84:16.00.00
AHFS class
Cell Stimulants And Proliferants
FDB label name
KEPIVANCE 6.25 MG VIAL
FDB brand name
Kepivance
Legend status
F — Federal legend — prescription drug or device
Biologic (Purple Book)
351(a)
Why two NDCs?
The FDA registers this code as 66658-112-06 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 66658-0112-06. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏭 Manufacturer & labeler
LabelerSwedish Orphan Biovitrum AB (publ)
FDA applicationBLA125103 (BLA)
Labeler code66658
Product typeHuman Prescription Drug
Portfolio16 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
Label name KEPIVANCE 6.25 MG VIAL Ingredient Palifermin
📖 What it is MedlinePlus · NLM
Palifermin is used to prevent and to speed the healing of severe sores in the mouth and throat that may be caused by chemotherapy and radiation therapy used to treat cancers of the blood or bone marrow (soft fatty material in the middle of bones that makes blood cells). Palifermin may not be safe to use to prevent and treat mouth sores in patients who have other types of cancer. Palifermin is in a class of medications called human keratinocyte growth factors. It works by stimulating the growth of cells in the mouth and throat.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- Kepivance is given to help protect the lining of your mouth and throat during the intense chemotherapy or radiation you receive before your stem cell transplant. That treatment can...
- What exactly is Kepivance for, and why am I getting it?
- Kepivance is given as a quick IV injection by your care team — not as a pill you take at home. You'll receive it once a day for 3 days before your chemotherapy starts, and then onc...
- The most common side effects are skin-related: rash, redness, itching, and swelling. You may also notice a thickened or discolored feeling in your mouth or on your tongue, a change...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Palifermin — tap one for details:
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about palifermin?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size:
3 vials
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Kepivance 6.25 mg/1.2mLthis 66658-0112-06 | Swedish | 6 vials | — | — | Discontinued | — |
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & biosimilar status
🏛️
2004
First FDA approval
Dec 2004
📍
2026
Currently FDA-listed
22 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
FDA Purple Book — biosimilars & interchangeables
ⓘ
Reference product
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for KEPIVANCE (this brand).
Top reported reactions
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 66658-0112-03 | 3 VIAL, SINGLE-USE in 1 CARTON (66658-112-03) / 1.2 mL in 1 VIAL, SINGLE-USE (66658-112-01) | 2009-12-15 | Discontinued by firm |
| 66658-0112-06 You're viewing this | 6 VIAL, SINGLE-USE in 1 CARTON (66658-112-06) / 1.2 mL in 1 VIAL, SINGLE-USE (66658-112-01) | 2009-12-15 | Discontinued by firm |
Pack size FAQ
What quantity is in NDC 66658-0112-06?
NDC 66658-0112-06 contains 6 vials — 6 vial, single-use in 1 carton / 1.2 ml in 1 vial, single-use.
What is the difference between NDC 66658-0112-06 and NDC 66658-0112-03?
Both are Kepivance palifermin 6.25 mg/1.2mL Injection, Powder, Lyophilized, For Solution — the drug itself is identical. NDC 66658-0112-06 is the 6 vials package, while NDC 66658-0112-03 is the 3 vials package.
What NDC number is used to bill for this package of Kepivance palifermin 6.25 mg/1.2mL Injection, Powder, Lyophilized, For Solution?
Bill NDC 66658-0112-06 — the 11-digit billing format is 66658011206. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 About this NDC listing & data coverage
Finished prescription product
No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA. |
| Package photos | — Not published for this NDC The FDA label for this product carries no photos. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 66658-112-06, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 66658-0112-06, written without dashes as 66658011206. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 66658-0112-06, the first segment (66658) is the labeler code FDA assigned to Swedish Orphan Biovitrum AB (publ); the middle segment (0112) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 3 vials (66658-0112-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Swedish Orphan Biovitrum AB (publ) is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 Full prescribing information FDA SPL
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.