NDC Code(s) : 61786-833-02
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:61786-833(NDC:51672-4001)
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
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C GREEN NO. 3(UNII: 3P3ONR6O1S)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
ALUMINUM OXIDE(UNII: LMI26O6933)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color green (Opaque, light green) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code TARO;NTP10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-833-0230 in 1 BLISTER PACK Type 0: Not a Combination Product19/08/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075520 08/19/2016

PRINCIPAL DISPLAY PANEL

DRUG: Nortriptyline Hydrochloride

GENERIC: Nortriptyline Hydrochloride

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 61786-833-02

COLOR: green

SHAPE: CAPSULE

SCORE: No score

SIZE: 18 mm

IMPRINT: TARO;NTP10

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • Nortriptyline Hydrochloride 10mg in 1

INACTIVE INGREDIENT(S):

  • FD&C Blue NO. 1
  • ferrosoferric oxide
  • shellac
  • FD&C Blue NO. 2
  • FD&C Red NO. 40
  • aluminum oxide
  • sodium lauryl sulfate
  • FD&C Green NO. 3
  • magnesium stearate
  • silicon dioxide
  • gelatin
  • D&C Yellow NO. 10
  • starch, corn
  • titanium dioxide

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