NDC Code(s) : 0179-0223-15
Packager : KAISER FOUNDATION HOSPITALS

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Nortriptyline HydrochlorideNortriptyline Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0179-0223(NDC:51862-015)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORTRIPTYLINE HYDROCHLORIDE(UNII: 00FN6IH15D)
(NORTRIPTYLINE - UNII:BL03SY4LXB) 		NORTRIPTYLINE10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
GELATIN(UNII: 2G86QN327L)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
BENZYL ALCOHOL(UNII: LKG8494WBH)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
EDETATE CALCIUM DISODIUM(UNII: 25IH6R4SGF)
SODIUM PROPIONATE(UNII: DK6Y9P42IN)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color green (opaque deep green), white (opaque white) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code NORTRIPTYLINE;DAN;10;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0179-0223-15105 in 1 BLISTER PACK Type 0: Not a Combination Product17/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073553 01/17/2017

PRINCIPAL DISPLAY PANEL

NDC 0179- 0223-15

Nortriptyline
Hydrochloride
Capsules, USP

10
mg*

PHARMACIST: Dispense the
Medication Guide provided
separately to each patient.

105 Capsules
Rx Only

PRINCIPAL DISPLAY PANEL - 10 mg Capsule Label