NDC 0076-0111

URIBEL

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

URIBEL is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Star Pharmaceuticals, Llc. The primary component is Methenamine; Sodium Phosphate, Monobasic, Monohydrate; Phenyl Salicylate; Methylene Blue; Hyoscyamine Sulfate.

• Product ID: 0076-0111_46e3b17c-53c9-6082-e054-00144ff8d46c
• NDC: 0076-0111
• Product Type: Human Prescription Drug
• Proprietary Name: URIBEL
• Generic Name: Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2010-08-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Star Pharmaceuticals, LLC
• Substance Name: METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE
• Active Ingredient Strength: 120 mg/1; mg/1; mg/1; mg/1; mg/1
• Pharm Classes: Oxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 0076-0111-02

20 POUCH in 1 BOX (0076-0111-02) > 1 CAPSULE in 1 POUCH

• Marketing Start Date: 2010-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0076-0111-02 [00076011102]

URIBEL CAPSULE

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-08-01
• Inactivation Date: 2020-01-31

NDC 0076-0111-01 [00076011101]

URIBEL CAPSULE

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-08-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
METHENAMINE	120 mg/1

OpenFDA Data

• SPL SET ID: fa2cc334-bd86-46cc-bc6a-12c71303f963
• Manufacturer:
  • Star Pharmaceuticals, LLC
• UNII:
  • 593YOG76RN
  • J50OIX95QV
  • T42P99266K
  • 28A37T47QO
  • F2R8V82B84
• RxNorm Concept Unique ID - RxCUI:
  • 1087367
  • 1087365

Pharmacological Class

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

NDC Crossover Matching brand name "URIBEL" or generic name "Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, And Hyoscyamine Sulfate"

NDC	Brand Name	Generic Name
0076-0111	URIBEL	Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
0178-0740	URIBEL	Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
0076-0902	Phosphasal	Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
44523-742	Phosphasal	Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
0682-0334	Urimar-T	Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
79043-334	Urimar-T	methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine sulfate
54859-701	Urin	Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
79043-450	URO-SP	Methenamine, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, and HYOSCYAMINE SULFATE
0076-0903	Ustell	Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
44523-743	Ustell	Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate