Prescription drug · NDA
Ellence (Epirubicin hydrochloride) NDC 0009-5091
Epirubicin hydrochloride 2 mg/mL · Injection, Solution · Intravenous · Pharmacia & Upjohn Company LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0009-5091-25 | 00009509125 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-25) / 25 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 LLCNDC labeler code 0009
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050778
- Marketing start
- Listing expires
- Other FDA classes
- Anthracyclines (Chemical structure)Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 0009-5091_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.
- NDC on a medical claim
N400009509125followed by a unit qualifier and the quantityPackage 00009-5091-25. 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 . 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.
About NDC 0009-5091
- What is NDC 0009-5091?
- 0009-5091 is the product NDC for Ellence (epirubicin hydrochloride), Epirubicin hydrochloride 2 mg/mL injection, solution, listed with the FDA by Pharmacia & Upjohn Company LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ellence (Epirubicin hydrochloride).
- What is the active ingredient?
- Epirubicin hydrochloride.
- Who is the labeler?
- Pharmacia & Upjohn Company LLC, NDC labeler code 0009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ellence?
- 1 other product NDC are listed under this name. See all Ellence NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ellence products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ellenceepirubicin hydrochloride | Epirubicin hydrochloride 2 mg/mL | Injection, SolutionIntravenous | Pharmacia & Upjohn Company LLC | 0009-5093 | 00009-5093-10 |
Other NDCs under NDA 050778
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ellenceepirubicin hydrochloride | Epirubicin hydrochloride 2 mg/mL | Injection, SolutionIntravenous | Pharmacia & Upjohn Company LLC | 0009-5093 |