Nortriptyline Hydrochloride (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 25 mg Capsule Bottle Label

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NORTRIPTYLINE HYDROCHLORIDE
nortriptyline hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-254(NDC:51672-4002)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLINE) NORTRIPTYLINE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C GREEN NO. 3
SODIUM LAURYL SULFATE
SHELLAC
FERROSOFERRIC OXIDE
FD&C BLUE NO. 2
ALUMINUM OXIDE
FD&C RED NO. 40
FD&C BLUE NO. 1
Product Characteristics
Color WHITE (Opaque, ivory) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code TARO;NTP25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53217-254-02 120 CAPSULE in 1 BOTTLE None
2 NDC:53217-254-30 30 CAPSULE in 1 BOTTLE None
3 NDC:53217-254-60 60 CAPSULE in 1 BOTTLE None
4 NDC:53217-254-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075520 05/08/2000
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 11/2016 Aidarex Pharmaceuticals LLC

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