Home NDC 0485-0151-01 UROGESIC BLUE
Product NDC 0485-0151
Requested package NDC 0485-0151-01
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 table Ingredient Strength METHENAMINE .12 mg/1 SODIUM PHOSPHATE, MONOBASIC 81.6 mg/1 METHYLENE BLUE 10.8 mg/1 HYOSCYAMINE SULFATE 40.8 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1050325 Internal RxNorm lookup 1251290 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYOSCYAMINE SULFATE ACTIVE INGREDIENT F2R8V82B84 UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 HYOSCYAMINE SULFATE ACTIVE INGREDIENT F2R8V82B84 UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 METHENAMINE ACTIVE INGREDIENT J50OIX95QV UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 METHENAMINE ACTIVE INGREDIENT J50OIX95QV UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 METHYLENE BLUE ACTIVE INGREDIENT T42P99266K UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 METHYLENE BLUE ACTIVE INGREDIENT T42P99266K UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 SODIUM PHOSPHATE, MONOBASIC ACTIVE INGREDIENT 3980JIH2SW UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 SODIUM PHOSPHATE, MONOBASIC ACTIVE INGREDIENT 3980JIH2SW UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 HYOSCYAMINE ACTIVE MOIETY PX44XO846X UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 HYOSCYAMINE ACTIVE MOIETY PX44XO846X UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 METHENAMINE ACTIVE MOIETY J50OIX95QV UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 METHENAMINE ACTIVE MOIETY J50OIX95QV UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 METHYLENE BLUE CATION ACTIVE MOIETY ZMZ79891ZH UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 METHYLENE BLUE CATION ACTIVE MOIETY ZMZ79891ZH UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 SODIUM CATION ACTIVE MOIETY LYR4M0NH37 UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 SODIUM CATION ACTIVE MOIETY LYR4M0NH37 UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join UROGESIC BLUE METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE EDWARDS PHARMACEUTICALS, INC. f650dd78-615c-42d3-9b2d-3a989039d80c 2026-03-05 Warnings, Adverse reactions Exact identifier ndc (package): 0485-0151-01 ndc (product): 0485-0151 ndc11 (package): 00485015101 UROGESIC BLUE METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE EDWARDS PHARMACEUTICALS, INC. d820e42d-ad2b-4e11-907b-a94d698ca285 2025-08-13 Warnings, Adverse reactions Exact identifier ndc (product): 0485-0151
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table 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 table 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