Venlafaxine Hydrochloride (Page 12 of 12)

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — LABEL — 37.5 MG

Rx only
NDC 16714-903-02
Venlafaxine Hydrochloride Extended-Release Tablets
37.5 mg
PHARMACIST: Dispense the Medication Guide provided separately to each patient.



90 Tablets
NORTHSTAR

venlafaxine-label-37-5mg
(click image for full-size original)
venlafaxine-label-37-5mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — LABEL — 75 MG

Rx only
NDC 16714-904-02

Venlafaxine Hydrochloride Extended-Release Tablets
75 mg
PHARMACIST: Dispense the Medication Guide provided separately to each patient.



90 Tablets
NORTHSTAR

venlafaxine-label-75mg
(click image for full-size original)

venlafaxine-label-75mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — LABEL — 150 MG

Rx only
NDC 16714-905-02
Venlafaxine Hydrochloride Extended-Release Tablets
150 mg
PHARMACIST: D ispense the Medication Guide provided separately to each patient.



90 Tablets
NORTHSTAR

venlafaxine-label-150mg
(click image for full-size original)

venlafaxine-label-150mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — LABEL — 225 MG

Rx only
NDC 16714-038-02
Venlafaxine Hydrochloride Extended-Release Tablets
225 mg
PHARMACIST: D ispense the Medication Guide provided separately to each patient.



90 Tablets
NORTHSTAR

venlafaxine-label-225mg
(click image for full-size original)

VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-903
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 37.5 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2208 (4000 MPA.S)
POVIDONE K30
LACTOSE MONOHYDRATE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
TALC
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (120 .MU.M)
SILICON DIOXIDE
SODIUM LAURYL SULFATE
FD&C RED NO. 40
MANNITOL
DIBUTYL SEBACATE
TRIETHYL CITRATE
POLYSORBATE 20
POLYETHYLENE GLYCOL 3350
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
Product Characteristics
Color PINK, WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 760
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-903-01 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:16714-903-02 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091272 04/10/2019
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-904
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 75 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2208 (4000 MPA.S)
POVIDONE K30
LACTOSE MONOHYDRATE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
TALC
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (120 .MU.M)
SILICON DIOXIDE
SODIUM LAURYL SULFATE
FD&C RED NO. 40
MANNITOL
DIBUTYL SEBACATE
TRIETHYL CITRATE
POLYSORBATE 20
POLYETHYLENE GLYCOL 3350
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
Product Characteristics
Color PINK, WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 759
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-904-01 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:16714-904-02 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091272 04/10/2019
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-905
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 150 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2208 (4000 MPA.S)
POVIDONE K30
LACTOSE MONOHYDRATE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
TALC
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (120 .MU.M)
SILICON DIOXIDE
SODIUM LAURYL SULFATE
FD&C RED NO. 40
MANNITOL
DIBUTYL SEBACATE
TRIETHYL CITRATE
POLYSORBATE 20
POLYETHYLENE GLYCOL 3350
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
Product Characteristics
Color PINK, WHITE Score no score
Shape OVAL Size 16mm
Flavor Imprint Code 758
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-905-01 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:16714-905-02 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091272 04/10/2019
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-038
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 225 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2208 (4000 MPA.S)
POVIDONE K30
LACTOSE MONOHYDRATE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
TALC
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (120 .MU.M)
SILICON DIOXIDE
SODIUM LAURYL SULFATE
FD&C RED NO. 40
MANNITOL
DIBUTYL SEBACATE
TRIETHYL CITRATE
POLYSORBATE 20
POLYETHYLENE GLYCOL 3350
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
Product Characteristics
Color PINK, WHITE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code 794
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-038-01 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:16714-038-02 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091272 10/21/2020
Labeler — NorthStar RxLLC (830546433)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 725959238 ANALYSIS (16714-038), ANALYSIS (16714-903), ANALYSIS (16714-904), ANALYSIS (16714-905), MANUFACTURE (16714-038), MANUFACTURE (16714-903), MANUFACTURE (16714-904), MANUFACTURE (16714-905)

Revised: 10/2020 NorthStar RxLLC

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