FDA.reportPublic FDA data

URIBEL TABS

Product NDC
0178-0745
11-digit product format
001780745
Labeler code
0178
Product ID
0178-0745_5dd35e13-2db2-67a8-e063-6294a90a6874
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Mission Pharmacal Company
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-11-07
Marketing end
2027-10-31
Substance
HYOSCYAMINE SULFATE; PHENYL SALICYLATE; METHENAMINE; METHYLENE BLUE; BENZOIC ACID
Active strength
.12; 36.2; 81.6; 10.8; 9 mg/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
URIBEL TABS

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMINE SULFATE.12 mg/1
PHENYL SALICYLATE36.2 mg/1
METHENAMINE81.6 mg/1
METHYLENE BLUE10.8 mg/1
BENZOIC ACID9 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
260b0da6-d3d7-262f-a60f-d4b36d5f1b4dProduct name620251210
c39b72c3-7732-4ed2-a995-e6aa3a665a54Product name320250819
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0745-01URIBEL TABS100 in 1 BOTTLETABLET, COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0745-01EA - Each0178-0745926c7a12-77ff-49f7-b40b-76f789bcb74f12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0745URIBEL TABS (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [MISSION PHARMACAL COMPANY]3Current NDC, 1 package rows20240123_09821e01-1135-e75c-e063-6294a90a3451.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1037234methenamine 81.6 MG / phenyl salicylate 36.2 MG / methylene blue 10.8 MG / benzoic acid 9 MG / hyoscyamine sulfate 0.12 MG Oral TabletPSN09821e01-1135-e75c-e063-6294a90a34514
2670308Uribel Tabs 81.6 MG / 9 MG / 36.2 MG / 10.8 MG / 0.12 MG Oral TabletPSN09821e01-1135-e75c-e063-6294a90a34514
2670308benzoic acid 9 MG / hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG Oral Tablet [Uribel Tabs]SBD09821e01-1135-e75c-e063-6294a90a34514
1037234benzoic acid 9 MG / hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG Oral TabletSCD09821e01-1135-e75c-e063-6294a90a34514
2670308Uribel Tabs (benzoic acid 9 MG / hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG) Oral TabletSY09821e01-1135-e75c-e063-6294a90a34514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0178-0745-0100178074501100 TABLET, COATED in 1 BOTTLE (0178-0745-01) 2023-11-072027-10-31NoNoHistorical