VENLAFAXINE HYDROCHLORIDE (Page 14 of 14)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg

Label
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Venlafaxine Hydrochloride Extended-Release Capsules, USP 75mg

label
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Venlafaxine Hydrochloride Extended-Release Capsules, USP 150mg

Label
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VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-018
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
ETHYLCELLULOSES
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
HYPROMELLOSES
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color gray (grey cap and peach body) Score no score
Shape CAPSULE (hard gelatin capsule) Size 15mm
Flavor Imprint Code 37;5;1018
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-018-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:13668-018-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:13668-018-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:13668-018-45 2600 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
5 NDC:13668-018-74 100 CAPSULE, EXTENDED RELEASE in 1 CARTON None
6 NDC:13668-018-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090899 01/06/2011
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-019
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
SILICON DIOXIDE
ETHYLCELLULOSES
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
GELATIN
HYPROMELLOSES
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color pink (pink cap and body) Score no score
Shape CAPSULE (hard gelatin capsule) Size 20mm
Flavor Imprint Code 75;1019
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-019-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:13668-019-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:13668-019-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:13668-019-46 850 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
5 NDC:13668-019-74 100 CAPSULE, EXTENDED RELEASE in 1 CARTON None
6 NDC:13668-019-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090899 01/06/2011
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-020
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
SILICON DIOXIDE
ETHYLCELLULOSES
FD&C RED NO. 40
FD&C YELLOW NO. 5
GELATIN
HYPROMELLOSES
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color orange (orange cap and body) Score no score
Shape CAPSULE (hard gelatin capsule) Size 22mm
Flavor Imprint Code 150;1020
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-020-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:13668-020-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:13668-020-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:13668-020-74 100 CAPSULE, EXTENDED RELEASE in 1 CARTON None
5 NDC:13668-020-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090899 01/06/2011
Labeler — Torrent Pharmaceuticals Limited (916488547)
Registrant — Torrent Pharma, Inc. (790033935)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 916488547 manufacture (13668-018), manufacture (13668-019), manufacture (13668-020)

Revised: 10/2019 Torrent Pharmaceuticals Limited

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