NDC Code(s) : 49349-106-02
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:49349-106
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE(UNII: 3U9A0FE9N5)
(DOXEPIN - UNII:5ASJ6HUZ7D) 		DOXEPIN75 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
STARCH, CORN(UNII: O8232NY3SJ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C GREEN NO. 3(UNII: 3P3ONR6O1S)
Product Characteristics
Color green Score 2 pieces
Shape CAPSULE (CAPSULE) Size 18 mm
Flavor Imprint Code MYLAN;5375
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-106-0230 in 1 BLISTER PACK Type 0: Not a Combination Product02/12/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070792 12/02/2010 12/03/2011

PRINCIPAL DISPLAY PANEL

DRUG: DOXEPIN HYDROCHLORIDE

GENERIC: DOXEPIN HYDROCHLORIDE

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 49349-106-02

STRENGTH:75 mg

COLOR: green

SHAPE: CAPSULE

SCORE: Two even pieces

SIZE: 18 mm

IMPRINT: MYLAN;5375

QTY: 30

/xml/0306cdb2-f143-4f55-9d63-f0508c842609/MM2.jpg





/xml/0306cdb2-f143-4f55-9d63-f0508c842609/MM2.jpg