NDC 68152-109

EVOMELA

Melphalan

EVOMELA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Spectrum Pharmaceuticals, Inc.. The primary component is Melphalan Hydrochloride.

Product ID68152-109_a2bff599-74e3-4d75-8978-38c2d51945e4
NDC68152-109
Product TypeHuman Prescription Drug
Proprietary NameEVOMELA
Generic NameMelphalan
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-03-31
Marketing CategoryNDA / NDA
Application NumberNDA207155
Labeler NameSpectrum Pharmaceuticals, Inc.
Substance NameMELPHALAN HYDROCHLORIDE
Active Ingredient Strength50 mg/10mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68152-109-00

1 VIAL in 1 CARTON (68152-109-00) > 20 mL in 1 VIAL
Marketing Start Date2016-03-31
Marketing End Date2022-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68152-109-00 [68152010900]

EVOMELA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA207155
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-31

Drug Details

Active Ingredients

IngredientStrength
MELPHALAN HYDROCHLORIDE50 mg/10mL

OpenFDA Data

SPL SET ID:c5d68b96-14bd-4605-b6d2-2bf8b0c5ca8a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1745090
  • 311487
  • Pharmacological Class

    • Alkylating Activity [MoA]
    • Alkylating Drug [EPC]
    • Alkylating Activity [MoA]
    • Alkylating Drug [EPC]

    NDC Crossover Matching brand name "EVOMELA" or generic name "Melphalan"

    NDCBrand NameGeneric Name
    68152-109EVOMELAMelphalan
    69605-001EVOMELAMelphalan
    72893-001EVOMELAMelphalan
    52609-0001ALKERANmelphalan

    Trademark Results [EVOMELA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EVOMELA
    EVOMELA
    86508057 4994159 Live/Registered
    ACROTECH BIOPHARMA LLC
    2015-01-20

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