| PRODUCT NDC | 0076-0111 | The 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 NAME | HUMAN PRESCRIPTION DRUG | Indicates 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 NAME | URIBEL | The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| NON PROPRIETARY NAME | Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| DOSAGE FORM NAME | CAPSULE | The translation of the dosage form Code submitted by the firm. |
| ROUTE NAME | ORAL | The translation of the route code submitted by the firm, indicating route of administration. |
| START MARKETING DATE | 8/1/2010 | This is the date that the labeler indicates was the start of its marketing of the drug product. |
| MARKETING CATEGORY NAME | UNAPPROVED DRUG OTHER | Product 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 NAME | Star Pharmaceuticals, LLC | Name of Company corresponding to the labeler code segment of the Product NDC. |
| SUBSTANCE NAME | METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE | This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| ACTIVE NUMERATOR STRENGTH | 120; 40.8; 36; 10; .12 | |
| ACTIVE INGRED UNIT | mg/1; mg/1; mg/1; mg/1; mg/1 | |
| PHARM CLASSES | 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] | |