NDC 70868-218

Urised

Methenamine, Phenyl Salicylate, Methylene Blue, Benzoic Acid, Atropine Sulfate , Hyoscyamine

Urised is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Key Therapeutics. The primary component is Methenamine; Phenyl Salicylate; Methylene Blue; Benzoic Acid; Atropine Sulfate; Hyoscyamine.

• Product ID: 70868-218_0d9f647e-5a81-4ac2-a73d-407a55f1186d
• NDC: 70868-218
• Product Type: Human Prescription Drug
• Proprietary Name: Urised
• Generic Name: Methenamine, Phenyl Salicylate, Methylene Blue, Benzoic Acid, Atropine Sulfate , Hyoscyamine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-01-17
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Key Therapeutics
• Substance Name: METHENAMINE; PHENYL SALICYLATE; METHYLENE BLUE; BENZOIC ACID; ATROPINE SULFATE; HYOSCYAMINE
• Active Ingredient Strength: 41 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
• Pharm Classes: Oxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70868-218-10

100 TABLET in 1 BOTTLE (70868-218-10)

• Marketing Start Date: 2019-01-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70868-218-10 [70868021810]

Urised TABLET

• Marketing Category: UNAPPROVED DRUG OTHER
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-17

Drug Details

Active Ingredients

Ingredient	Strength
METHENAMINE	40.8 mg/1

OpenFDA Data

• SPL SET ID: d8e5364a-ac4c-4715-979b-21c9f535d12c
• Manufacturer:
  • Key Therapeutics
• UNII:
  • J50OIX95QV
  • T42P99266K
  • PX44XO846X
  • 28A37T47QO
  • 03J5ZE7KA5
  • 8SKN0B0MIM
• RxNorm Concept Unique ID - RxCUI:
  • 1046914
  • 1046820

Pharmacological Class

• Oxidation-Reduction Activity [MoA]
• Oxidation-Reduction Agent [EPC]
• Ammonium Ion Binding Activity [MoA]
• Nitrogen Binding Agent [EPC]
• Anticholinergic [EPC]
• Cholinergic Antagonists [MoA]
• Cholinergic Muscarinic Antagonist [EPC]
• Cholinergic Muscarinic Antagonists [MoA]
• Oxidation-Reduction Activity [MoA]
• Oxidation-Reduction Agent [EPC]
• Ammonium Ion Binding Activity [MoA]
• Nitrogen Binding Agent [EPC]
• Anticholinergic [EPC]
• Cholinergic Antagonists [MoA]
• Cholinergic Muscarinic Antagonist [EPC]
• Cholinergic Muscarinic Antagonists [MoA]