NDC Code(s) : 61786-257-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Doxazosin MesylateDoxazosin Mesylate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-257(NDC:67253-380)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXAZOSIN MESYLATE(UNII: 86P6PQK0MU)
(DOXAZOSIN - UNII:NW1291F1W8) 		DOXAZOSIN1 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE B POTATO(UNII: 27NA468985)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
LACTOSE(UNII: J2B2A4N98G)
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 10 mm
Flavor Imprint Code 1;mg;ML;P16
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-257-0230 in 1 BLISTER PACK Type 0: Not a Combination Product14/04/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076161 04/14/2015

PRINCIPAL DISPLAY PANEL

DRUG: Doxazosin Mesylate

GENERIC: Doxazosin Mesylate

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-257-02

COLOR: white

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 10 mm

IMPRINT: 1;mg;ML;P16

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • DOXAZOSIN MESYLATE 1mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • SODIUM LAURYL SULFATE
  • LACTOSE
  • MAGNESIUM STEARATE
  • SODIUM STARCH GLYCOLATE TYPE B POTATO

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