urelle

Generic: hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name urelle
Generic Name hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate
Labeler viatris specialty llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hyoscyamine sulfate .12 mg/1, methenamine 81 mg/1, methylene blue 10.8 mg/1, phenyl salicylate 32.4 mg/1, sodium phosphate, monobasic, monohydrate 40.8 mg/1

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 0037-6321
Product ID 0037-6321_a8f8f4f1-ad2a-40af-9089-764a459fb8fd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2015-01-12

Pharmacologic Class

Classes
oxidation-reduction activity [moa] oxidation-reduction agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00376321
Hyphenated Format 0037-6321

Supplemental Identifiers

RxCUI
1048336 1048340
UNII
F2R8V82B84 J50OIX95QV T42P99266K 28A37T47QO 593YOG76RN

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name urelle (source: ndc)
Generic Name hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .12 mg/1
  • 81 mg/1
  • 10.8 mg/1
  • 32.4 mg/1
  • 40.8 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (0037-6321-90)
source: ndc

Packages (1)

0037-6321-90 90 TABLET in 1 BOTTLE (0037-6321-90)

Ingredients (5)

hyoscyamine sulfate (.12 mg/1) methenamine (81 mg/1) methylene blue (10.8 mg/1) phenyl salicylate (32.4 mg/1) sodium phosphate, monobasic, monohydrate (40.8 mg/1)

Linked Drug Pages (1)

URELLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a8f8f4f1-ad2a-40af-9089-764a459fb8fd", "openfda": {"unii": ["F2R8V82B84", "J50OIX95QV", "T42P99266K", "28A37T47QO", "593YOG76RN"], "rxcui": ["1048336", "1048340"], "spl_set_id": ["1d80a11c-6f86-403b-85d4-32ec1924dbe9"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (0037-6321-90)", "package_ndc": "0037-6321-90", "marketing_start_date": "20150112"}], "brand_name": "URELLE", "product_id": "0037-6321_a8f8f4f1-ad2a-40af-9089-764a459fb8fd", "dosage_form": "TABLET", "pharm_class": ["Oxidation-Reduction Activity [MoA]", "Oxidation-Reduction Agent [EPC]"], "product_ndc": "0037-6321", "generic_name": "hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "URELLE", "active_ingredients": [{"name": "HYOSCYAMINE SULFATE", "strength": ".12 mg/1"}, {"name": "METHENAMINE", "strength": "81 mg/1"}, {"name": "METHYLENE BLUE", "strength": "10.8 mg/1"}, {"name": "PHENYL SALICYLATE", "strength": "32.4 mg/1"}, {"name": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE", "strength": "40.8 mg/1"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20150112", "listing_expiration_date": "20261231"}