NDC Code(s) : 35573-300-10
Packager : Burel Pharmaceuticals, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

URAMIT MBMethenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35573-300
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHENAMINE(UNII: J50OIX95QV)
(METHENAMINE - UNII:J50OIX95QV) 		METHENAMINE118 mg
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)
(SODIUM CATION - UNII:LYR4M0NH37) 		SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE40.8 mg
PHENYL SALICYLATE(UNII: 28A37T47QO)
(PHENYL SALICYLATE - UNII:28A37T47QO) 		PHENYL SALICYLATE36 mg
METHYLENE BLUE(UNII: T42P99266K)
(METHYLENE BLUE CATION - UNII:ZMZ79891ZH) 		METHYLENE BLUE10 mg
HYOSCYAMINE SULFATE(UNII: F2R8V82B84)
(Hyoscyamine - UNII:PX44XO846X) 		HYOSCYAMINE SULFATE0.12 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: L11K75P92J)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE B POTATO(UNII: 27NA468985)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
CARBOMER 934(UNII: Z135WT9208)
Product Characteristics
Color purple Score no score
Shape capsule Size 19 mm
Flavor Imprint Code BL;300
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35573-300-10100 in 1 BOTTLE Type 0: Not a Combination Product26/06/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/26/2015 11/01/2016

PRINCIPAL DISPLAY PANEL

NDC 35573-300-10

URAMIT MB™

EACH CAPSULE CONTAINS

Methenamine 118 mg
Sodium Phosphate Monobasic 40.8 mg
Phenyl Salicylate 36 mg
Methylene Blue 10 mg
Hyoscyamine Sulfate 0.12 mg

Rx ONLY

100 Capsules

URAMIT MB™ is a trademark of Burel Pharmaceuticals, Inc

Manufactured for:
Burel Pharmaceuticals, Inc
Richland, MS 39218

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label