NDC 0009-5091

Ellence

Epirubicin Hydrochloride

Ellence is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmacia & Upjohn Company Llc. The primary component is Epirubicin Hydrochloride.

• Product ID: 0009-5091_00ba8044-31f3-4c9f-9fd7-172e2ac036f9
• NDC: 0009-5091
• Product Type: Human Prescription Drug
• Proprietary Name: Ellence
• Generic Name: Epirubicin Hydrochloride
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1999-09-15
• Marketing Category: NDA / NDA
• Application Number: NDA050778
• Labeler Name: Pharmacia & Upjohn Company LLC
• Substance Name: EPIRUBICIN HYDROCHLORIDE
• Active Ingredient Strength: 2 mg/mL
• Pharm Classes: Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0009-5091-01

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

• Marketing Start Date: 1999-09-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0009-5091-01 [00009509101]

Ellence INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA050778
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1999-09-15

Drug Details

Active Ingredients

Ingredient	Strength
EPIRUBICIN HYDROCHLORIDE	2 mg/mL

OpenFDA Data

• SPL SET ID: 0a03c798-a652-4895-b29c-3b521a89ba42
• Manufacturer:
  • Pharmacia and Upjohn Company LLC
• UNII:
  • 22966TX7J5
• RxNorm Concept Unique ID - RxCUI:
  • 1732183
  • 1732182
  • 1732187
  • 1732186

Pharmacological Class

• Anthracycline Topoisomerase Inhibitor [EPC]
• Anthracyclines [CS]
• Topoisomerase Inhibitors [MoA]

NDC Crossover Matching brand name "Ellence" or generic name "Epirubicin Hydrochloride"

NDC	Brand Name	Generic Name
0009-5091	Ellence	epirubicin hydrochloride
0009-5093	Ellence	epirubicin hydrochloride
0115-1675	Epirubicin Hydrochloride	Epirubicin Hydrochloride
0143-9202	Epirubicin Hydrochloride	Epirubicin Hydrochloride
0143-9203	Epirubicin Hydrochloride	Epirubicin Hydrochloride
25021-203	Epirubicin Hydrochloride	epirubicin hydrochloride
45963-608	Epirubicin Hydrochloride	Epirubicin Hydrochloride
59923-701	EPIRUBICIN HYDROCHLORIDE	EPIRUBICIN HYDROCHLORIDE
63323-151	Epirubicin Hydrochloride	epirubicin hydrochloride
66758-042	Epirubicin Hydrochloride	Epirubicin Hydrochloride