0178-0740 NDC - URIBEL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE)

Drug Information

Product NDC: 0178-0740

Proprietary Name: URIBEL

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

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


Administration Route(s): ORAL

Dosage Form(s): CAPSULE

Pharmacy Class(es):
  • Increased Large Intestinal Motility [PE];
  • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE];
  • Osmotic Activity [MoA];
  • Osmotic Laxative [EPC];
  • Oxidation-Reduction Activity [MoA];
  • Oxidation-Reduction Agent [EPC]

Labeler Information

Labeler Name: Mission Pharmacal Company
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:4/15/2019

Package Information

No. Package Code Package Description Billing Unit
10178-0740-01100 CAPSULE in 1 BOTTLE (0178-0740-01)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0178-0740The 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 DATE4/15/2019This 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 NAMEMission Pharmacal CompanyName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEHYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH.12; 118; 10; 36; 40.8 
ACTIVE INGRED UNITmg/1; mg/1; mg/1; mg/1; mg/1 
PHARM CLASSESIncreased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC] 

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This page was last updated on: 2/1/2023