Venlafaxine Hydrochloride (Page 15 of 15)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Venlafaxine Hydrochloride Extended-Release Capsules USP 37.5 mg-30 Capsules

Venlafaxine Hydrochloride 30 capsules
(click image for full-size original)

Venlafaxine Hydrochloride Extended-Release Capsules USP 75 mg-30 Capsules

Venlafaxine Hydrochloride 75mg 30 capsules
(click image for full-size original)

Venlafaxine Hydrochloride Extended-Release Capsules USP 150 mg-30 Capsules

Venlafaxine Hydrochloride 150mg 30 capsules
(click image for full-size original)
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-002
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
ETHYLCELLULOSE, UNSPECIFIED
HYPROMELLOSE 2910 (5 MPA.S)
SUCROSE
STARCH, CORN
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
SHELLAC
AMMONIA
POTASSIUM HYDROXIDE
Product Characteristics
Color gray, white Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code V;9
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-002-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:31722-002-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:31722-002-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:31722-002-01 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (31722-002-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212277 07/08/2019
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-003
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
ETHYLCELLULOSE, UNSPECIFIED
HYPROMELLOSE 2910 (5 MPA.S)
SUCROSE
STARCH, CORN
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
GELATIN
SHELLAC
AMMONIA
POTASSIUM HYDROXIDE
Product Characteristics
Color pink (Peach) , white Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code V;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-003-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:31722-003-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:31722-003-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:31722-003-01 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (31722-003-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212277 07/08/2019
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-004
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
ETHYLCELLULOSE, UNSPECIFIED
HYPROMELLOSE 2910 (5 MPA.S)
SUCROSE
STARCH, CORN
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
SHELLAC
AMMONIA
POTASSIUM HYDROXIDE
Product Characteristics
Color orange, white Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code V;11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:31722-004-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:31722-004-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:31722-004-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:31722-004-01 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (31722-004-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212277 07/08/2019
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Annora Pharma Private Limited 650980746 analysis (31722-002), analysis (31722-003), analysis (31722-004), manufacture (31722-002), manufacture (31722-003), manufacture (31722-004)

Revised: 11/2021 Camber Pharmaceuticals, Inc.

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