NDC Code(s) : 49349-505-02
Packager : REMEDYREPACK 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:49349-505(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(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:49349-505-0230 in 1 BLISTER PACK Type 0: Not a Combination Product10/08/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073554 08/10/2010

PRINCIPAL DISPLAY PANEL

DRUG: Nortriptyline Hydrochloride

GENERIC: Nortriptyline Hydrochloride

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 49349-505-02

COLOR: green

SHAPE: CAPSULE

SCORE: No score

SIZE: 19 mm

IMPRINT: NORTRIPTYLINE;DAN;25;mg

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • NORTRIPTYLINE HYDROCHLORIDE 25mg in 1

INACTIVE INGREDIENT(S):

  • BENZYL ALCOHOL
  • BUTYLPARABEN
  • EDETATE CALCIUM DISODIUM
  • SILICON DIOXIDE
  • D&C YELLOW NO. 10
  • FD&C BLUE NO. 1
  • SODIUM PROPIONATE
  • GELATIN
  • MAGNESIUM STEARATE
  • SODIUM LAURYL SULFATE
  • STARCH, CORN
  • METHYLPARABEN
  • PROPYLPARABEN
  • TITANIUM DIOXIDE

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