NDC 48992-001

Monsels Solution

Ferric Subsulfate

Monsels Solution is a Topical Paste in the Human Prescription Drug category. It is labeled and distributed by Gynex Corporation. The primary component is Ferric Subsulfate.

Product ID48992-001_87bf38d0-9013-47d7-b8a8-c925b3d51832
NDC48992-001
Product TypeHuman Prescription Drug
Proprietary NameMonsels Solution
Generic NameFerric Subsulfate
Dosage FormPaste
Route of AdministrationTOPICAL
Marketing Start Date2020-03-13
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameGynex Corporation
Substance NameFERRIC SUBSULFATE
Active Ingredient Strength210 mg/g
Pharm ClassesIron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 48992-001-01

14 g in 1 VIAL, SINGLE-DOSE (48992-001-01)
Marketing Start Date2020-03-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 48992-001-01 [48992000101]

Monsels Solution PASTE
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-13

Drug Details

Active Ingredients

IngredientStrength
FERRIC SUBSULFATE210 mg/g

OpenFDA Data

SPL SET ID:170ce265-2951-47a6-8f56-a27cc39cbdf8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 831162
  • Pharmacological Class

    • Iron [CS]
    • Parenteral Iron Replacement [EPC]
    • Phosphate Binder [EPC]
    • Phosphate Chelating Activity [MoA]

    NDC Crossover Matching brand name "Monsels Solution" or generic name "Ferric Subsulfate"

    NDCBrand NameGeneric Name
    10481-0112MONSELS SOLUTIONFERRIC SUBSULFATE
    42721-112Monsels solutionFerric Sub Sulfate 20%
    48783-112Monsels SolutionFerric Subsulfate
    48992-001Monsels SolutionFerric Subsulfate
    70880-112Monsels SolutionFerric Subsulfate
    59365-5006Ferric SubsulfateFerric Subsulfate
    59365-6065Ferric SubsulfateFerric Subsulfate
    66915-301StiptikFerric Subsulfate

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