NDC 58657-458

Uro-458

Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue And Hyoscyamine Sulfate

Uro-458 is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Method Pharmaceuticals, Llc. The primary component is Methenamine; Sodium Phosphate, Monobasic, Anhydrous; Phenyl Salicylate; Methylene Blue; Hyoscyamine Sulfate.

Product ID58657-458_37229472-72d0-07ee-e054-00144ff88e88
NDC58657-458
Product TypeHuman Prescription Drug
Proprietary NameUro-458
Generic NameMethenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue And Hyoscyamine Sulfate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-06-17
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameMethod Pharmaceuticals, LLC
Substance NameMETHENAMINE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE
Active Ingredient Strength81 mg/1; mg/1; mg/1; mg/1; mg/1
Pharm ClassesOsmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58657-458-90

90 TABLET in 1 BOTTLE (58657-458-90)
Marketing Start Date2016-06-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58657-458-90 [58657045890]

Uro-458 TABLET
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-17
Inactivation Date2020-01-31
Reactivation Date2020-02-11

Drug Details

Active Ingredients

IngredientStrength
METHENAMINE81 mg/1

OpenFDA Data

SPL SET ID:370dc1da-b45a-008b-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1048336
  • UPC Code
  • 0358657458904
  • Pharmacological Class

    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]
    • Oxidation-Reduction Activity [MoA]
    • Oxidation-Reduction Agent [EPC]

    NDC Crossover Matching brand name "Uro-458" or generic name "Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue And Hyoscyamine Sulfate"

    NDCBrand NameGeneric Name
    58657-458Uro-458Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate
    58657-456Uro-MPMethenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate
    15338-502UroAv-81Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate
    42291-851UroAv-81Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate
    15338-503UroAv-BMethenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate
    42291-852UroAv-BMethenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate

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