0037-6321 NDC - URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE)

Drug Information

Product NDC: 0037-6321

Proprietary Name: URELLE

Non Proprietary Name: hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate

Active Ingredient(s):
  • .12 mg/1 HYOSCYAMINE SULFATE;
  • 81 mg/1 METHENAMINE;
  • 10.8 mg/1 METHYLENE BLUE;
  • 32.4 mg/1 PHENYL SALICYLATE;
  • 40.8 mg/1 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE


Administration Route(s): ORAL

Dosage Form(s): TABLET

Pharmacy Class(es):
  • Oxidation-Reduction Activity [MoA];
  • Oxidation-Reduction Agent [EPC]

Labeler Information

Labeler Name: Meda Pharmaceuticals
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:1/12/2015

Package Information

No. Package Code Package Description Billing Unit
10037-6321-9090 TABLET in 1 BOTTLE (0037-6321-90)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0037-6321The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEURELLEThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEhyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/12/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEMeda PharmaceuticalsName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEHYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH.12; 81; 10.8; 32.4; 40.8 
ACTIVE INGRED UNITmg/1; mg/1; mg/1; mg/1; mg/1 
PHARM CLASSESOxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC] 

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 5/17/2019