Prescription Drug Information: Venlafaxine Hydrochloride (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP
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VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-1728(NDC:68382-035)
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
CETOSTEARYL ALCOHOL
GELATIN
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
Product Characteristics
Color orange (PEACH) , white (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 20mm
Flavor Imprint Code ZA;36;75;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-1728-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090174 06/01/2011
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 relabel (68071-1728)

Revised: 04/2021 NuCare Pharmaceuticals,Inc.

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