NDC 0037-6321

URELLE

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

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

Product ID0037-6321_3c4ac6f5-f382-4cf7-aa0d-87959fa0c705
NDC0037-6321
Product TypeHuman Prescription Drug
Proprietary NameURELLE
Generic NameHyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, And Sodium Phosphate, Monobasic, Monohydrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-01-12
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameMeda Pharmaceuticals
Substance NameHYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Active Ingredient Strength0 mg/1; mg/1; mg/1; mg/1; mg/1
Pharm ClassesOxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0037-6321-90

90 TABLET in 1 BOTTLE (0037-6321-90)
Marketing Start Date2015-01-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0037-6321-90 [00037632190]

URELLE TABLET
Marketing CategoryUnapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-12

Drug Details

Active Ingredients

IngredientStrength
HYOSCYAMINE SULFATE.12 mg/1

OpenFDA Data

SPL SET ID:1d80a11c-6f86-403b-85d4-32ec1924dbe9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1048336
  • 1048340

    • Pharmacological Class

    • Oxidation-Reduction Activity [MoA]
    • Oxidation-Reduction Agent [EPC]
    • Oxidation-Reduction Activity [MoA]
    • Oxidation-Reduction Agent [EPC]

    Trademark Results [URELLE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    URELLE
    URELLE
    85481729 4220875 Dead/Cancelled
    DSM IP Assets B.V.
    2011-11-28
    URELLE
    URELLE
    77860362 3806629 Live/Registered
    MEDA PHARMA S.A.R.L.
    2009-10-29
    URELLE
    URELLE
    76405748 2697669 Dead/Cancelled
    AZUR PHARMA INTERNATIONAL II LIMITED
    2002-05-10
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