ellence

Generic: epirubicin hydrochloride

Labeler: pharmacia & upjohn company llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ellence
Generic Name epirubicin hydrochloride
Labeler pharmacia & upjohn company llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

epirubicin hydrochloride 2 mg/mL

Manufacturer
Pharmacia & Upjohn Company LLC

Identifiers & Regulatory

Product NDC 0009-5091
Product ID 0009-5091_fb8fdcc7-9949-486f-a487-0eebd44cb40e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050778
Listing Expiration 2026-12-31
Marketing Start 1999-09-15

Pharmacologic Class

Classes
anthracycline topoisomerase inhibitor [epc] anthracyclines [cs] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00095091
Hyphenated Format 0009-5091

Supplemental Identifiers

RxCUI
1732182 1732183 1732186 1732187
UNII
22966TX7J5

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ellence (source: ndc)
Generic Name epirubicin hydrochloride (source: ndc)
Application Number NDA050778 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-01) / 25 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-25) / 25 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

0009-5091-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-01) / 25 mL in 1 VIAL, SINGLE-DOSE 0009-5091-25 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-25) / 25 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

epirubicin hydrochloride (2 mg/mL)

Linked Drug Pages (1)

Ellence ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fb8fdcc7-9949-486f-a487-0eebd44cb40e", "openfda": {"unii": ["22966TX7J5"], "rxcui": ["1732182", "1732183", "1732186", "1732187"], "spl_set_id": ["0a03c798-a652-4895-b29c-3b521a89ba42"], "manufacturer_name": ["Pharmacia & Upjohn Company LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-01)  / 25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0009-5091-01", "marketing_start_date": "19990915"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-25)  / 25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0009-5091-25", "marketing_start_date": "20250324"}], "brand_name": "Ellence", "product_id": "0009-5091_fb8fdcc7-9949-486f-a487-0eebd44cb40e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "0009-5091", "generic_name": "epirubicin hydrochloride", "labeler_name": "Pharmacia & Upjohn Company LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ellence", "active_ingredients": [{"name": "EPIRUBICIN HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "NDA050778", "marketing_category": "NDA", "marketing_start_date": "19990915", "listing_expiration_date": "20261231"}