Desmopressin acetate tablet

Ingredients and appearance - Product information

Desmopressin acetate tablet- Desmopressin acetate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68001-325
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Desmopressin acetate ( UNII: XB13HYU18U)( Desmopressin - UNII: ENR1LLB0FP ) 0.1 mgin 1

Inactive Ingredients

Ingredient Name Code
Starch, potato ( UNII: 8I089SAH3T)
Talc ( UNII: 7SEV7J4R1U)
Magnesium stearate ( UNII: 70097M6I30)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Povidone ( UNII: FZ989GH94E)

Product Characteristics

Color white (white to off-white) Size 9 mm
Shape OVAL Score 2
Imprint Code S

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 68001-325-00 100 in 1 BOTTLE 2017/04/30

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA201831 USA 2017/04/30

Desmopressin acetate tablet- Desmopressin acetate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68001-326
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Desmopressin acetate ( UNII: XB13HYU18U)( Desmopressin - UNII: ENR1LLB0FP ) 0.2 mgin 1

Inactive Ingredients

Ingredient Name Code
Povidone ( UNII: FZ989GH94E)
Starch, potato ( UNII: 8I089SAH3T)
Talc ( UNII: 7SEV7J4R1U)
Magnesium stearate ( UNII: 70097M6I30)
Lactose monohydrate ( UNII: EWQ57Q8I5X)

Product Characteristics

Color white (white to off-white) Size 8 mm
Shape ROUND Score 2
Imprint Code I

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 68001-326-00 100 in 1 BOTTLE 2017/04/30

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA201831 USA 2017/04/30

Labeler - BluePoint Laboratories( 985523874)

Establishment

Name ID/FEI Business Operations
BluePoint Laboratories 985523874 analysis( 68001-325, 68001-326), manufacture( 68001-325, 68001-326)