NDC Code(s) : 61786-319-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Venlafaxine HydrochlorideVenlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-319(NDC:65862-697)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE(UNII: 7D7RX5A8MO)
(VENLAFAXINE - UNII:GRZ5RCB1QG) 		VENLAFAXINE150 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE (20 MPA.S)(UNII: BJG0S321QY)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color orange (Opaque Dark Orange) Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code E;89
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-319-0230 in 1 BLISTER PACK Type 0: Not a Combination Product06/01/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200834 06/01/2015

PRINCIPAL DISPLAY PANEL

DRUG: Venlafaxine Hydrochloride

GENERIC: Venlafaxine Hydrochloride

DOSAGE: CAPSULE, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 61786-319-02

COLOR: orange

SHAPE: CAPSULE

SCORE: No score

SIZE: 21 mm

IMPRINT: E;89

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • VENLAFAXINE HYDROCHLORIDE 150mg in 1

INACTIVE INGREDIENT(S):

  • ETHYLCELLULOSE (20 MPA.S)
  • TITANIUM DIOXIDE
  • GELATIN, UNSPECIFIED
  • FERROSOFERRIC OXIDE
  • SODIUM LAURYL SULFATE
  • FERRIC OXIDE RED
  • HYPROMELLOSE 2910 (5 MPA.S)
  • SHELLAC
  • SUCROSE
  • STARCH, CORN
  • TALC

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