NDC Code(s) : 42799-962-01, 42799-962-02, 42799-963-01, 42799-963-02
Packager : Edenbridge Pharmaceuticals LLC.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

venlafaxine hydrochloride, extended release venlafaxine hydrochloride, extended release TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:42799-962
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
CARNAUBA WAX(UNII: R12CBM0EIZ)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW)(UNII: XRK36F13ZZ)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ACETATE(UNII: 32K497ZK2U)
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)(UNII: 23ZQ42JZZH)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STEARETH-20(UNII: L0Q8IK9E08)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE (imprint in blue) Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code 150mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42799-962-0130 in 1 BOTTLE Type 0: Not a Combination Product15/03/2023
2NDC:42799-962-0290 in 1 BOTTLE Type 0: Not a Combination Product15/03/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209193 03/15/2023
venlafaxine hydrochloride, extended release venlafaxine hydrochloride, extended release TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:42799-963
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE(UNII: 7D7RX5A8MO)
(VENLAFAXINE - UNII:GRZ5RCB1QG) 		VENLAFAXINE225 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX(UNII: R12CBM0EIZ)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW)(UNII: XRK36F13ZZ)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ACETATE(UNII: 32K497ZK2U)
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)(UNII: 23ZQ42JZZH)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STEARETH-20(UNII: L0Q8IK9E08)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE (imprint in blue) Score no score
Shape ROUND Size 13 mm
Flavor Imprint Code 225mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42799-963-0130 in 1 BOTTLE Type 0: Not a Combination Product15/03/2023
2NDC:42799-963-0290 in 1 BOTTLE Type 0: Not a Combination Product15/03/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209193 03/15/2023

LABELER - Edenbridge Pharmaceuticals LLC.(948715060)

PRINCIPAL DISPLAY PANEL

150-30150-30150-30150-30