Utira-C

Product NDC
0178-0513
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0178-0513DDiscontinued by firm2026-10-05
excluded packagepackage0178-05130178-0513-01DDiscontinued by firm2026-10-05

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0178-0513-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0178-0513-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0178-0513-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0178-0513-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0178-0513-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0178-0513-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0178-0513-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0178-0513-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0178-0513-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0178-0513-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0178-0513-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0178-0513-01557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0513-01EA - Each0178-051308d0574f-9e08-48c8-8be5-8592c0b55abe12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYOSCYAMINE SULFATEACTIVE INGREDIENTF2R8V82B84UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
METHENAMINEACTIVE INGREDIENTJ50OIX95QVUTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
METHYLENE BLUEACTIVE INGREDIENTT42P99266KUTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
PHENYL SALICYLATEACTIVE INGREDIENT28A37T47QOUTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
SODIUM PHOSPHATE, MONOBASICACTIVE INGREDIENT3980JIH2SWUTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
HYOSCYAMINEACTIVE MOIETYPX44XO846XUTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
METHENAMINEACTIVE MOIETYJ50OIX95QVUTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
METHYLENE BLUE CATIONACTIVE MOIETYZMZ79891ZHUTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
PHENYL SALICYLATEACTIVE MOIETY28A37T47QOUTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRUTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JUTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UUTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKUTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDUTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AUTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990UTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APUTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
TALCINACTIVE INGREDIENT7SEV7J4R1UUTIRA-C (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, HYOSCYAMINE SULFATE) TABLET [MISSION PHARMACAL COMPANY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPUTIRA-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 NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0178-0513-0100178051301100 TABLET in 1 BOTTLE (0178-0513-01) 100 tablet2011-09-110000-00-00NoNoCurrent