NDC 42023-149

Melphalan Hydrochloride

Melphalan Hydrochloride

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

Product ID42023-149_67fde26e-6c43-4a79-bd9f-ec383f964cf4
NDC42023-149
Product TypeHuman Prescription Drug
Proprietary NameMelphalan Hydrochloride
Generic NameMelphalan Hydrochloride
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-08-26
Marketing CategoryANDA / ANDA
Application NumberANDA204773
Labeler NamePar Pharmaceutical, Inc.
Substance NameMELPHALAN
Active Ingredient Strength50 mg/10mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42023-149-01

10 mL in 1 VIAL (42023-149-01)
Marketing Start Date2016-08-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42023-149-01 [42023014901]

Melphalan Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204773
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-08-26
Marketing End Date2019-04-30

Drug Details

Active Ingredients

IngredientStrength
MELPHALAN50 mg/10mL

OpenFDA Data

SPL SET ID:1922268b-f093-4a35-8549-8450d4660921
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311487
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    10139-321Melphalan HydrochlorideMelphalan Hydrochloride
    25021-221Melphalan HydrochlorideMelphalan Hydrochloride
    42023-149Melphalan HydrochlorideMelphalan Hydrochloride
    43598-027Melphalan HydrochlorideMelphalan Hydrochloride
    43598-392Melphalan HydrochlorideMelphalan Hydrochloride
    45963-686Melphalan HydrochlorideMelphalan Hydrochloride
    50742-477MELPHALAN HYDROCHLORIDEMELPHALAN HYDROCHLORIDE
    54288-109Melphalan hydrochlorideMelphalan Hydrochloride
    67457-195Melphalan HydrochlorideMelphalan Hydrochloride
    67457-215Melphalan HydrochlorideMelphalan Hydrochloride
    67457-579Melphalan HydrochlorideMelphalan Hydrochloride
    68083-259Melphalan hydrochlorideMelphalan hydrochloride
    70700-278MELPHALAN HYDROCHLORIDEMELPHALAN HYDROCHLORIDE
    70860-214Melphalan Hydrochloridemelphalan hydrochloride
    71288-112Melphalan hydrochlorideMelphalan hydrochloride
    71288-132Melphalan hydrochlorideMelphalan hydrochloride
    72266-128Melphalan hydrochlorideMelphalan hydrochloride
    72611-779melphalan hydrochloridemelphalan hydrochloride
    52609-3001ALKERANmelphalan hydrochloride
    54288-106MelphalanMelphalan Hydrochloride
    63323-760MelphalanMelphalan Hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.