What is NDC 66658-113?

66658-113 is the product NDC for Kepivance (palifermin), Palifermin 5.16 mg/1.2mL injection, powder, lyophilized, for solution, listed with the FDA by Swedish Orphan Biovitrum AB (publ). It has 1 package NDC, shown above in 10- and 11-digit form.

Swedish Orphan Biovitrum AB (publ), NDC labeler code 66658. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Kepivance?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Kepivance NDC 66658-113 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)66658-113Labeler and product segments. Claims need a package NDC.

Product NDC at billing width66658-0113Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
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)Marketed from Aug 4, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Kepivance
Generic name (nonproprietary): palifermin
Active ingredients: Palifermin — 5.16 mg/1.2mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Swedish Orphan Biovitrum AB (publ)NDC labeler code 66658
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125103
Marketing start: Aug 4, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Fibroblast Growth Factor 7 (Chemical structure)Increased Epithelial Proliferation (Physiologic effect)
Identifiers: Product ID 66658-113_462812de-e664-609f-e063-6294a90a1e3dSPL ID 462812de-e664-609f-e063-6294a90a1e3dSPL set ID 426f6e64-2c20-4a61-6d65-7320426f6e64RxCUI 2643434, 2643436UNII QMS40680K6
Pharmacologic class: Mucocutaneous Epithelial Cell Growth Factor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N466658011303 followed by a unit qualifier and the quantity

Package 66658-0113-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Dec 17, 2025.

Indications (excerpt from the label)

Kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support. Kepivance is indicated as supportive care for preparative regimens predicted to result in ≥ WHO Grade 3 mucositis in the majority of patients. ( 1.1 ) Limitations of Use The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies ( 1.2 , 5.1 ) Kepivance was not effective in decreasing the incidence of severe mucositis in patients with hematologic malignancies receiving myelotoxic t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 66658-113

What is NDC 66658-113?: 66658-113 is the product NDC for Kepivance (palifermin), Palifermin 5.16 mg/1.2mL injection, powder, lyophilized, for solution, listed with the FDA by Swedish Orphan Biovitrum AB (publ). It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Kepivance (Palifermin).
What is the active ingredient?: Palifermin.
Who is the labeler?: Swedish Orphan Biovitrum AB (publ), NDC labeler code 66658. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Kepivance?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Kepivance (Palifermin) NDC 66658-113