NDC Code(s) : 55566-5060-1, 55566-5061-1
Packager : Ferring Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Desmopressin AcetateDesmopressin acetate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55566-5060
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Desmopressin acetate(UNII: XB13HYU18U)
(Desmopressin - UNII:ENR1LLB0FP) 		Desmopressin acetate0.1 mg
Inactive Ingredients
Ingredient Name Strength
lactose(UNII: J2B2A4N98G)
starch, potato(UNII: 8I089SAH3T)
magnesium stearate(UNII: 70097M6I30)
povidones(UNII: FZ989GH94E)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 8 mm
Flavor Imprint Code 0;1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55566-5060-1100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021795 05/05/2008
Desmopressin AcetateDesmopressin acetate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55566-5061
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Desmopressin acetate(UNII: XB13HYU18U)
(Desmopressin - UNII:ENR1LLB0FP) 		Desmopressin acetate0.2 mg
Inactive Ingredients
Ingredient Name Strength
lactose(UNII: J2B2A4N98G)
starch, potato(UNII: 8I089SAH3T)
magnesium stearate(UNII: 70097M6I30)
povidones(UNII: FZ989GH94E)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10 mm
Flavor Imprint Code 0;2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55566-5061-1100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021795 05/05/2008

PRINCIPAL DISPLAY PANEL

NDC 55566-5060-1

Desmopressin Acetate
Tablets

0.1 mg

100 Tablets
Rx only

FERRING
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 0.1 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 55566-5060-1

Desmopressin Acetate
Tablets

0.1 mg

100 Tablets
Rx only

FERRING
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 0.1 mg Tablet Bottle Carton

PRINCIPAL DISPLAY PANEL

NDC 55566-5061-1

Desmopressin Acetate
Tablets

0.2 mg

100 Tablets
Rx only

FERRING
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 0.2 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 55566-5061-1

Desmopressin Acetate
Tablets

0.2 mg

100 Tablets
Rx only

FERRING
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 0.2 mg Tablet Bottle Carton