URIBEL
- Product NDC
- 0076-0111
- 11-digit product format
- 000760111
- Labeler code
- 0076
- Product ID
- 0076-0111_46e3b17c-53c9-6082-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Star Pharmaceuticals, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2010-08-01
- Marketing end
- 0000-00-00
- Substance
- METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE
- Active strength
- 120 mg/1; mg/1; mg/1; mg/1; mg/1
- Pharmacologic 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]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0076-0111-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f4e4-f424-e053-dadaa90a57ce | Uribel ™ |
| 0076-0111-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f4e4-f424-e053-dadaa90a57ce | Uribel ™ |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0076-0111-01 | URIBEL | 100 in 1 BOTTLE | CAPSULE | 100 | 8 | |
| 0076-0111-02 | URIBEL | 1 in 1 POUCH | CAPSULE | 1 | 8 | |
| 0076-0111-02 | URIBEL | 20 in 1 BOX | CAPSULE | 20 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0076-0111-01 | EA - Each | 0076-0111 | b857eb27-817a-4fcc-b734-18fb480f4869 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0076-0111 | URIBEL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS, LLC] | 8 | Legacy NDC, 3 package rows | 20170125_fa2cc334-bd86-46cc-bc6a-12c71303f963.zip |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 0076-0111-01 | 00076011101 | 100 in 1 BOTTLE | Historical |
| 0076-0111-02 | 00076011102 | 1 in 1 POUCH | Historical |