NDC Code(s) : 49349-463-02, 49349-463-24
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Doxepin Hydrochloridedoxepin hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-463
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE(UNII: 3U9A0FE9N5)
(DOXEPIN - UNII:5ASJ6HUZ7D) 		DOXEPIN100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C GREEN NO. 3(UNII: 3P3ONR6O1S)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color green Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code MYLAN;6410
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-463-0230 in 1 BLISTER PACK Type 0: Not a Combination Product12/10/2010
2NDC:49349-463-24200 in 1 CANISTER Type 0: Not a Combination Product12/10/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070791 10/12/2010 12/12/2013

PRINCIPAL DISPLAY PANEL

DRUG: Doxepin Hydrochloride

GENERIC: doxepin hydrochloride

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 49349-463-02

COLOR: green

SHAPE: CAPSULE

SCORE: No score

SIZE: 19 mm

IMPRINT: MYLAN;6410

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • DOXEPIN HYDROCHLORIDE 100mg in 1

INACTIVE INGREDIENT(S):

  • FD&C BLUE NO. 1
  • FD&C BLUE NO. 2
  • FERROSOFERRIC OXIDE
  • FD&C GREEN NO. 3
  • FD&C RED NO. 40
  • PROPYLENE GLYCOL
  • SHELLAC
  • SILICON DIOXIDE
  • CELLULOSE, MICROCRYSTALLINE
  • GELATIN
  • MAGNESIUM STEARATE
  • STARCH, CORN
  • D&C YELLOW NO. 10
  • SODIUM LAURYL SULFATE
  • TITANIUM DIOXIDE

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