Home NDC 0178-0513-01 Utira-C
Product NDC 0178-0513
Requested package NDC 0178-0513-01
11-digit product format 001780513
Labeler code 0178
Product ID 0178-0513_ec09b934-f13a-64d5-e053-2995a90ae626
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methenamine, sodium phosphate monobasic, phenyl salicylate, methylene blue, hyoscyamine sulfate
Dosage form TABLET
Route ORAL
Labeler Mission Pharmacal Company
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2011-09-11
Marketing end 0000-00-00
Substance HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC
Active strength 0 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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYOSCYAMINE SULFATE ACTIVE INGREDIENT F2R8V82B84 UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 METHENAMINE ACTIVE INGREDIENT J50OIX95QV UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 METHYLENE BLUE ACTIVE INGREDIENT T42P99266K UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 PHENYL SALICYLATE ACTIVE INGREDIENT 28A37T47QO UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 SODIUM PHOSPHATE, MONOBASIC ACTIVE INGREDIENT 3980JIH2SW UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 HYOSCYAMINE ACTIVE MOIETY PX44XO846X UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 METHENAMINE ACTIVE MOIETY J50OIX95QV UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 METHYLENE BLUE CATION ACTIVE MOIETY ZMZ79891ZH UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 PHENYL SALICYLATE ACTIVE MOIETY 28A37T47QO UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 PHOSPHATE ION ACTIVE MOIETY NK08V8K8HR UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0178-0513-01 00178051301 100 TABLET in 1 BOTTLE (0178-0513-01) 100 tablet 2011-09-11 0000-00-00 No No Current