URELLE
- Product NDC
- 0037-6321
- 11-digit product format
- 000376321
- Labeler code
- 0037
- Product ID
- 0037-6321_a8f8f4f1-ad2a-40af-9089-764a459fb8fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Viatris Specialty LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2015-01-12
- Substance
- HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
- Active strength
- .12; 81; 10.8; 32.4; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- URELLE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYOSCYAMINE SULFATE | .12 mg/1 |
| METHENAMINE | 81 mg/1 |
| METHYLENE BLUE | 10.8 mg/1 |
| PHENYL SALICYLATE | 32.4 mg/1 |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 40.8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F2R8V82B84, J50OIX95QV, T42P99266K, 28A37T47QO, 593YOG76RN |
| Rxcui | 1048336, 1048340 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0037-6321-90 | URELLE | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYOSCYAMINE SULFATE | ACTIVE INGREDIENT | F2R8V82B84 | URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] | 1 | |
| METHENAMINE | ACTIVE INGREDIENT | J50OIX95QV | URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] | 1 | |
| METHYLENE BLUE | ACTIVE INGREDIENT | T42P99266K | URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] | 1 | |
| PHENYL SALICYLATE | ACTIVE INGREDIENT | 28A37T47QO | URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] | 1 | |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | ACTIVE INGREDIENT | 593YOG76RN | URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] | 1 | |
| HYOSCYAMINE | ACTIVE MOIETY | PX44XO846X | URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] | 1 | |
| METHENAMINE | ACTIVE MOIETY | J50OIX95QV | URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] | 1 | |
| METHYLENE BLUE CATION | ACTIVE MOIETY | ZMZ79891ZH | URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] | 1 | |
| PHENYL SALICYLATE | ACTIVE MOIETY | 28A37T47QO | URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] | 1 | |
| PHOSPHATE ION | ACTIVE MOIETY | NK08V8K8HR | URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0037-6321 | URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS] | 3 | Current NDC, Legacy NDC, 1 package rows | 20181205_1d80a11c-6f86-403b-85d4-32ec1924dbe9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0037-6321-90 | 00037632190 | 90 TABLET in 1 BOTTLE (0037-6321-90) | 90 tablet | 2015-01-12 | 0000-00-00 | No | No | Current |