NDC Code(s) : 68788-9969-3, 68788-9969-6, 68788-9969-9, 68788-9969-1, 68788-9324-3, 68788-9324-6, 68788-9324-9, 68788-9324-1
Packager : Preferred Pharmaceuticals, Inc.

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:68788-9969(NDC:0591-5787)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORTRIPTYLINE HYDROCHLORIDE(UNII: 00FN6IH15D)
(NORTRIPTYLINE - UNII:BL03SY4LXB) 		NORTRIPTYLINE25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
GELATIN, UNSPECIFIED(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 19 mm
Flavor Imprint Code NORTRIPTYLINE;DAN;25;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68788-9969-330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product13/04/2015
2NDC:68788-9969-660 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product13/04/2015
3NDC:68788-9969-990 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product13/04/2015
4NDC:68788-9969-1100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product13/04/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073554 04/13/2015
Nortriptyline HydrochlorideNortriptyline Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-9324(NDC:0591-5788)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORTRIPTYLINE HYDROCHLORIDE(UNII: 00FN6IH15D)
(NORTRIPTYLINE - UNII:BL03SY4LXB) 		NORTRIPTYLINE50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
GELATIN, UNSPECIFIED(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)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE (opaque white) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code NORTRIPTYLINE;DAN;50;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68788-9324-330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product05/07/2015
2NDC:68788-9324-660 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product05/07/2015
3NDC:68788-9324-990 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product05/07/2015
4NDC:68788-9324-1100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product05/07/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073555 05/07/2015

PRINCIPAL DISPLAY PANEL

NDC 68788-9324
Nortriptyline
Hydrochloride
Capsules USP
25 mg*

*Each capsule contains:
Notriptyline Hydrochloride equivalent
to 25 mg Notriptyline

Usual Dosage: See package insert for
dosage and full prescribing information.

Dispense in a tight container, as definied
in the USP, with a child-resistant closure.

PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY.

Store at 20º - 25º C (68º - 77º F).
[See USP controlled room temperature.]

Manufactured By:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA
Code No. GO/DRUGS/741 173675

Distributed By: Watson Pharma, Inc.

Repackaged By: Preferred Pharmaceuticals Inc.

Nortriptyline Hydrochloride Capsules USP 25mg

PRINCIPAL DISPLAY PANEL

NDC 68788-9969

Nortriptyline
Hydrochloride
Capsules USP
50 mg*

*Each capsule contains:
Notriptyline Hydrochloride equivalent
to 50 mg Notriptyline

Usual Dosage: See package insert for
dosage and full prescribing information.

Dispense in a tight container, as definied
in the USP, with a child-resistant closure.

PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY.

Store at 20º - 25º C (68º - 77º F).
[See USP controlled room temperature.]

Manufactured By:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA
Code No. GO/DRUGS/741 173677

Distributed By: Watson Pharma, Inc.

Repackaged By: Preferred Pharmaceuticals Inc.

Nortriptyline Hydrochloride Capsules USP 50mg