Vivelle-Dot (Page 10 of 10)

PRINCIPAL DISPLAY PANEL

Package Label – 0.1 mg

Rx Only NDC 0078-0346-42

Vivelle-Dot® (estradiol transdermal system)

Delivers 0.1 mg/day

Includes 8 Systems

PRINCIPAL DISPLAY PANEL
Package Label – 0.1 mg 
Rx Only		NDC 0078-0346-42
Vivelle Dot® (estradiol transdermal system)
Delivers 0.1 mg/day
Includes 8 Systems
(click image for full-size original)

VIVELLE-DOT estradiol patch, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0365
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.025 mg in 1 d
Inactive Ingredients
Ingredient Name Strength
OLEYL ALCOHOL
POVIDONE
ISOPROPYL ALCOHOL
NITROGEN
DIPROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0365-42 8 POUCH in 1 BOX contains a POUCH (0078-0365-62)
1 NDC:0078-0365-62 1 PATCH in 1 POUCH This package is contained within the BOX (0078-0365-42) and contains a PATCH
1 3.5 d in 1 PATCH This package is contained within a POUCH (0078-0365-62) and a BOX (0078-0365-42)
2 NDC:0078-0365-45 3 BOX in 1 CARTON contains a BOX
2 8 POUCH in 1 BOX This package is contained within the CARTON (0078-0365-45) and contains a POUCH
2 1 PATCH in 1 POUCH This package is contained within the BOX and contains a PATCH
2 3.5 d in 1 PATCH This package is contained within a POUCH and a BOX and a CARTON (0078-0365-45)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020538 01/08/1999
VIVELLE-DOT estradiol patch, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0343
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.0375 mg in 1 d
Inactive Ingredients
Ingredient Name Strength
OLEYL ALCOHOL
POVIDONE
ISOPROPYL ALCOHOL
NITROGEN
DIPROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0343-45 3 BOX in 1 CARTON contains a BOX (0078-0343-42)
1 NDC:0078-0343-42 8 POUCH in 1 BOX This package is contained within the CARTON (0078-0343-45) and contains a POUCH (0078-0343-62)
1 NDC:0078-0343-62 1 PATCH in 1 POUCH This package is contained within the BOX (0078-0343-42) and contains a PATCH
1 3.5 d in 1 PATCH This package is contained within a POUCH (0078-0343-62) and a BOX (0078-0343-42) and a CARTON (0078-0343-45)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020538 01/08/1999
VIVELLE-DOT estradiol patch, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0344
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.05 mg in 1 d
Inactive Ingredients
Ingredient Name Strength
OLEYL ALCOHOL
POVIDONE
ISOPROPYL ALCOHOL
NITROGEN
DIPROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0344-45 3 BOX in 1 CARTON contains a BOX (0078-0344-42)
1 NDC:0078-0344-42 8 POUCH in 1 BOX This package is contained within the CARTON (0078-0344-45) and contains a POUCH (0078-0344-62)
1 NDC:0078-0344-62 1 PATCH in 1 POUCH This package is contained within the BOX (0078-0344-42) and contains a PATCH
1 3.5 d in 1 PATCH This package is contained within a POUCH (0078-0344-62) and a BOX (0078-0344-42) and a CARTON (0078-0344-45)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020538 01/08/1999
VIVELLE-DOT estradiol patch, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0345
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.075 mg in 1 d
Inactive Ingredients
Ingredient Name Strength
OLEYL ALCOHOL
POVIDONE
ISOPROPYL ALCOHOL
NITROGEN
DIPROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0345-42 8 POUCH in 1 BOX contains a POUCH (0078-0345-62)
1 NDC:0078-0345-62 1 PATCH in 1 POUCH This package is contained within the BOX (0078-0345-42) and contains a PATCH
1 3.5 d in 1 PATCH This package is contained within a POUCH (0078-0345-62) and a BOX (0078-0345-42)
2 NDC:0078-0345-45 3 BOX in 1 CARTON contains a BOX
2 8 POUCH in 1 BOX This package is contained within the CARTON (0078-0345-45) and contains a POUCH
2 1 PATCH in 1 POUCH This package is contained within the BOX and contains a PATCH
2 3.5 d in 1 PATCH This package is contained within a POUCH and a BOX and a CARTON (0078-0345-45)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020538 01/08/1999
VIVELLE-DOT estradiol patch, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0346
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.1 mg in 1 d
Inactive Ingredients
Ingredient Name Strength
OLEYL ALCOHOL
POVIDONE
ISOPROPYL ALCOHOL
NITROGEN
DIPROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0346-42 8 POUCH in 1 BOX contains a POUCH (0078-0346-62)
1 NDC:0078-0346-62 1 PATCH in 1 POUCH This package is contained within the BOX (0078-0346-42) and contains a PATCH
1 3.5 d in 1 PATCH This package is contained within a POUCH (0078-0346-62) and a BOX (0078-0346-42)
2 NDC:0078-0346-45 3 BOX in 1 CARTON contains a BOX
2 8 POUCH in 1 BOX This package is contained within the CARTON (0078-0346-45) and contains a POUCH
2 1 PATCH in 1 POUCH This package is contained within the BOX and contains a PATCH
2 3.5 d in 1 PATCH This package is contained within a POUCH and a BOX and a CARTON (0078-0346-45)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020538 01/08/1999
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 06/2020 Novartis Pharmaceuticals Corporation

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