UROGESIC BLUE
- Product NDC
- 0485-0151
- 11-digit product format
- 004850151
- Labeler code
- 0485
- Product ID
- 0485-0151_3c4170bc-d3bf-74df-e063-6294a90ad846
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, and HYOSCYAMINE SULFATE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- EDWARDS PHARMACEUTICALS, INC.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2010-11-19
- Substance
- HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; SODIUM PHOSPHATE, MONOBASIC
- Active strength
- .12; 81.6; 10.8; 40.8 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- 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]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- UROGESIC BLUE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYOSCYAMINE SULFATE | .12 mg/1 |
| METHENAMINE | 81.6 mg/1 |
| METHYLENE BLUE | 10.8 mg/1 |
| SODIUM PHOSPHATE, MONOBASIC | 40.8 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | F2R8V82B84, J50OIX95QV, T42P99266K, 3980JIH2SW |
| Rxcui | 1050325, 1251290 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0485-0151-01 | 2025-08-19 | C162847 | 48780-1 | 3b156c62-2599-fb37-e063-e6dba90a4e07 | UROGESIC-BLUE™ |
| 0485-0151-30 | 2025-08-15 | C162847 | 48780-1 | 3b156c62-32f5-fb37-e063-e6dba90a4e07 | UROGESIC-BLUE™ |
| 0485-0151-01 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-2599-fb37-e063-e6dba90a4e07 | UROGESIC-BLUE™ |
| 0485-0151-30 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-32f5-fb37-e063-e6dba90a4e07 | UROGESIC-BLUE™ |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0485-0151-01 | UROGESIC BLUE | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | 6 | |
| 0485-0151-30 | UROGESIC BLUE | 30 in 1 BOTTLE, PLASTIC | TABLET, COATED | 30 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0485-0151-01 | EA - Each | 0485-0151 | b6d2b268-e65b-455d-ae8b-87dfc7c59fdb | 1 | 2013-03-03 |
| 0485-0151-30 | EA - Each | 0485-0151 | a14ff71e-902f-47cc-aeed-0822723514c2 | 1 | 2015-03-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0485-0151 | UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20230111_f650dd78-615c-42d3-9b2d-3a989039d80c.zip |
| 0485-0151 | UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20230115_d820e42d-ad2b-4e11-907b-a94d698ca285.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1050325 | methenamine 81.6 MG / sodium phosphate, monobasic 40.8 MG / methylene blue 10.8 MG / hyoscyamine sulfate 0.12 MG Oral Tablet | PSN | f650dd78-615c-42d3-9b2d-3a989039d80c | 6 |
| 1251290 | UROGESIC-BLUE 81.6 MG / 40.8 MG / 10.8 MG / 0.12 MG Oral Tablet, Reformulated Apr 2012 | PSN | f650dd78-615c-42d3-9b2d-3a989039d80c | 6 |
| 1251290 | hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / sodium phosphate, monobasic 40.8 MG Oral Tablet [Urogesic Blue Reformulated Apr 2012] | SBD | f650dd78-615c-42d3-9b2d-3a989039d80c | 6 |
| 1050325 | hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / sodium phosphate, monobasic 40.8 MG Oral Tablet | SCD | f650dd78-615c-42d3-9b2d-3a989039d80c | 6 |
| 1251290 | Urogesic Blue (hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / sodium phosphate, monobasic 40.8 MG) Oral Tablet, Reformulated Apr 2012 | SY | f650dd78-615c-42d3-9b2d-3a989039d80c | 6 |
| 1050325 | methenamine 81.6 MG / sodium phosphate, monobasic 40.8 MG / methylene blue 10.8 MG / hyoscyamine sulfate 0.12 MG Oral Tablet | PSN | d820e42d-ad2b-4e11-907b-a94d698ca285 | 4 |
| 1251290 | UROGESIC-BLUE 81.6 MG / 40.8 MG / 10.8 MG / 0.12 MG Oral Tablet, Reformulated Apr 2012 | PSN | d820e42d-ad2b-4e11-907b-a94d698ca285 | 4 |
| 1251290 | hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / sodium phosphate, monobasic 40.8 MG Oral Tablet [Urogesic Blue Reformulated Apr 2012] | SBD | d820e42d-ad2b-4e11-907b-a94d698ca285 | 4 |
| 1050325 | hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / sodium phosphate, monobasic 40.8 MG Oral Tablet | SCD | d820e42d-ad2b-4e11-907b-a94d698ca285 | 4 |
| 1251290 | Urogesic Blue (hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / sodium phosphate, monobasic 40.8 MG) Oral Tablet, Reformulated Apr 2012 | SY | d820e42d-ad2b-4e11-907b-a94d698ca285 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0485-0151-01 | 00485015101 | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0151-01) | 2010-11-19 | 0000-00-00 | No | No | Current |
| 0485-0151-30 | 00485015130 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0151-30) | 2010-11-19 | 0000-00-00 | No | No | Current |