NDC 48783-112

Monsels Solution

Ferric Subsulfate

Monsels Solution is a Topical Paste in the Human Prescription Drug category. It is labeled and distributed by Premier Dental Products Company. The primary component is Ferric Subsulfate.

Product ID48783-112_938bf724-6293-4f64-8e1a-5a000f47180f
NDC48783-112
Product TypeHuman Prescription Drug
Proprietary NameMonsels Solution
Generic NameFerric Subsulfate
Dosage FormPaste
Route of AdministrationTOPICAL
Marketing Start Date2014-06-10
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NamePremier Dental Products Company
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 Through2022-12-31

Packaging

NDC 48783-112-08

14 g in 1 VIAL, SINGLE-DOSE (48783-112-08)
Marketing Start Date2014-06-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 48783-112-08 [48783011208]

Monsels Solution PASTE
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-06-10

Drug Details

Active Ingredients

IngredientStrength
FERRIC SUBSULFATE210 mg/g

OpenFDA Data

SPL SET ID:7a9923af-b8ed-4dc5-b6ae-2f42f83eb3db
Manufacturer
UNII

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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