0076-0111 NDC - URIBEL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE)

Drug Information

Product NDC: 0076-0111

Proprietary Name: URIBEL

Non Proprietary Name: Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate

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


Administration Route(s): ORAL

Dosage Form(s): CAPSULE

Pharmacy Class(es):
  • 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]

Labeler Information

Labeler Name: Star Pharmaceuticals, LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:8/1/2010

Package Information

No. Package Code Package Description Billing Unit
10076-0111-01100 CAPSULE in 1 BOTTLE (0076-0111-01)EA
20076-0111-0220 POUCH in 1 BOX (0076-0111-02) > 1 CAPSULE in 1 POUCH

NDC Record

Field Name Field Value Definition
PRODUCT NDC0076-0111The 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 NAMEURIBELThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEMethenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine SulfateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULEThe 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 DATE8/1/2010This 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 NAMEStar Pharmaceuticals, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEMETHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH120; 40.8; 36; 10; .12 
ACTIVE INGRED UNITmg/1; mg/1; mg/1; mg/1; mg/1 
PHARM CLASSESOxidation-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] 

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