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 ID: 58657-458_37229472-72d0-07ee-e054-00144ff88e88
• NDC: 58657-458
• Product Type: Human Prescription Drug
• Proprietary Name: Uro-458
• Generic Name: Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue And Hyoscyamine Sulfate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-06-17
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Method Pharmaceuticals, LLC
• Substance Name: METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE
• Active Ingredient Strength: 81 mg/1; mg/1; mg/1; mg/1; mg/1
• Pharm Classes: 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 Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58657-458-90

90 TABLET in 1 BOTTLE (58657-458-90)

• Marketing Start Date: 2016-06-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58657-458-90 [58657045890]

Uro-458 TABLET

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-06-17
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-11

Drug Details

Active Ingredients

Ingredient	Strength
METHENAMINE	81 mg/1

OpenFDA Data

• SPL SET ID: 370dc1da-b45a-008b-e054-00144ff8d46c
• Manufacturer:
  • Method Pharmaceuticals, LLC
• UNII:
  • J50OIX95QV
  • T42P99266K
  • 28A37T47QO
  • KH7I04HPUU
  • F2R8V82B84
• 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"

NDC	Brand Name	Generic Name
58657-458	Uro-458	Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate
58657-456	Uro-MP	Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate
15338-502	UroAv-81	Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate
42291-851	UroAv-81	Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate
15338-503	UroAv-B	Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate
42291-852	UroAv-B	Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate