Ellence (epirubicin hydrochloride) NDC 0009-5093

NDC codes

FDA NDC Directory

Product NDC (as listed)0009-5093Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00009-5093Add 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
0009-5093-10	00009509310	1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5093-10) / 100 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 24, 2025

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Ellence
Generic name (nonproprietary): epirubicin hydrochloride
Active ingredients: Epirubicin hydrochloride — 2 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Pharmacia & Upjohn Company LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 050778
Marketing start: Sep 15, 1999
Listing expires: Dec 31, 2027
Other FDA classes: Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 0009-5093_9ee2fe09-ff4e-4bfb-9b38-f15ea77cf1d8SPL ID 9ee2fe09-ff4e-4bfb-9b38-f15ea77cf1d8SPL set ID 0a03c798-a652-4895-b29c-3b521a89ba42RxCUI 1732182, 1732183, 1732186, 1732187UNII 22966TX7J5
Pharmacologic class: Anthracycline Topoisomerase Inhibitor

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

N400009509310 followed by a unit qualifier and the quantity

Package 00009-5093-10. 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 Jul 24, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1) ] . ELLENCE is an anthracycline topoisomerase inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 050778

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 050778
Product	Strength	Form · route	Labeler	Product NDC
Ellenceepirubicin hydrochloride	Epirubicin hydrochloride 2 mg/mL	Injection, SolutionIntravenous	Pharmacia & Upjohn Company LLC	0009-5091