Desmopressin Acetate (Page 4 of 4)

PRINCIPAL DISPLAY PANEL

NDC 16714-883-01

Desmopressin Acetate Tablets

0.1 mg — 100 Tablets

desmopressin-ace-0pt1mg-bottle-100-tab-label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 16714-884-01

Desmopressin Acetate Tablets

0.2 mg — 100 Tablets

desmopressin-ace-0pt2mg-bottle-100-tab-label
(click image for full-size original)
DESMOPRESSIN ACETATE desmopressin acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-883
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESMOPRESSIN ACETATE (DESMOPRESSIN) DESMOPRESSIN ACETATE 0.1 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, POTATO
TALC
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
LACTOSE MONOHYDRATE
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code S
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-883-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201831 05/28/2015
DESMOPRESSIN ACETATE desmopressin acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-884
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESMOPRESSIN ACETATE (DESMOPRESSIN) DESMOPRESSIN ACETATE 0.2 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, POTATO
TALC
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
LACTOSE MONOHYDRATE
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-884-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201831 05/28/2015
Labeler — Northstar Rx LLC (830546433)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Ltd. 677318665 ANALYSIS (16714-883), ANALYSIS (16714-884), MANUFACTURE (16714-883), MANUFACTURE (16714-884)

Revised: 11/2018 Northstar Rx LLC

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