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 ID0009-5091_00ba8044-31f3-4c9f-9fd7-172e2ac036f9
NDC0009-5091
Product TypeHuman Prescription Drug
Proprietary NameEllence
Generic NameEpirubicin Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1999-09-15
Marketing CategoryNDA / NDA
Application NumberNDA050778
Labeler NamePharmacia & Upjohn Company LLC
Substance NameEPIRUBICIN HYDROCHLORIDE
Active Ingredient Strength2 mg/mL
Pharm ClassesAnthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0009-5091-01

1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-01) > 25 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date1999-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0009-5091-01 [00009509101]

Ellence INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA050778
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1999-09-15

Drug Details

Active Ingredients

IngredientStrength
EPIRUBICIN HYDROCHLORIDE2 mg/mL

OpenFDA Data

SPL SET ID:0a03c798-a652-4895-b29c-3b521a89ba42
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0009-5091Ellenceepirubicin hydrochloride
    0009-5093Ellenceepirubicin hydrochloride
    0115-1675Epirubicin HydrochlorideEpirubicin Hydrochloride
    0143-9202Epirubicin HydrochlorideEpirubicin Hydrochloride
    0143-9203Epirubicin HydrochlorideEpirubicin Hydrochloride
    25021-203Epirubicin Hydrochlorideepirubicin hydrochloride
    45963-608Epirubicin HydrochlorideEpirubicin Hydrochloride
    59923-701EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDE
    63323-151Epirubicin Hydrochlorideepirubicin hydrochloride
    66758-042Epirubicin HydrochlorideEpirubicin Hydrochloride

    Trademark Results [Ellence]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ELLENCE
    ELLENCE
    75681188 2443310 Live/Registered
    PFIZER INC.
    1999-04-12

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