NDC 0485-0151

UROGESIC BLUE

Methenamine, Sodium Phosphate, Monobasic, Methylene Blue, And Hyoscyamine Sulfate

UROGESIC BLUE is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Edwards Pharmaceuticals, Inc.. The primary component is Methenamine; Sodium Phosphate, Monobasic; Methylene Blue; Hyoscyamine Sulfate.

• Product ID: 0485-0151_10109075-6a32-4562-9dc8-c148a61d5d58
• NDC: 0485-0151
• Product Type: Human Prescription Drug
• Proprietary Name: UROGESIC BLUE
• Generic Name: Methenamine, Sodium Phosphate, Monobasic, Methylene Blue, And Hyoscyamine Sulfate
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2010-11-19
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: EDWARDS PHARMACEUTICALS, INC.
• Substance Name: METHENAMINE; SODIUM PHOSPHATE, MONOBASIC; METHYLENE BLUE; HYOSCYAMINE SULFATE
• Active Ingredient Strength: 82 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 0485-0151-30

30 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0151-30)

• Marketing Start Date: 2010-11-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0485-0151-30 [00485015130]

UROGESIC BLUE TABLET, COATED

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-11-19

NDC 0485-0151-01 [00485015101]

UROGESIC BLUE TABLET, COATED

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-11-19

Drug Details

Active Ingredients

Ingredient	Strength
METHENAMINE	81.6 mg/1

OpenFDA Data

• SPL SET ID: f650dd78-615c-42d3-9b2d-3a989039d80c
• Manufacturer:
  • EDWARDS PHARMACEUTICALS, INC.
• UNII:
  • 3980JIH2SW
  • J50OIX95QV
  • T42P99266K
  • F2R8V82B84
• RxNorm Concept Unique ID - RxCUI:
  • 1251290
  • 1050325

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]