Prescription Drug Information: Desvenlafaxine

DESVENLAFAXINE- desvenlafaxine tablet, extended release
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68382-469-67 in bottle of 14 tablets in unit-of-use package

Desvenlafaxine Extended-release Tablets, 50 mg

14 tablets

Rx only

Zydus

Desvenlafaxine tablets
(click image for full-size original)

NDC 68382-741-67 in bottle of 14 tablets in unit-of-use package

Desvenlafaxine Extended-release Tablets, 100 mg

14 tablets

Rx only

Zydus

Desvenlafaxine tablets
(click image for full-size original)
DESVENLAFAXINE
desvenlafaxine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1311
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESVENLAFAXINE (DESVENLAFAXINE) DESVENLAFAXINE 50 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
STEARIC ACID
TALC
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape SQUARE (SQUARE) Size 9mm
Flavor Imprint Code 469
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1311-7 14 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1311-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70771-1311-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:70771-1311-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
5 NDC:70771-1311-5 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
6 NDC:70771-1311-0 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
7 NDC:70771-1311-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1311-2)
7 NDC:70771-1311-2 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (70771-1311-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204020 05/08/2018
DESVENLAFAXINE
desvenlafaxine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1312
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESVENLAFAXINE (DESVENLAFAXINE) DESVENLAFAXINE 100 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
STEARIC ACID
TALC
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color ORANGE (ORANGE) Score no score
Shape SQUARE (SQUARE) Size 9mm
Flavor Imprint Code 741
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1312-7 14 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1312-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70771-1312-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:70771-1312-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
5 NDC:70771-1312-5 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
6 NDC:70771-1312-0 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
7 NDC:70771-1312-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1312-2)
7 NDC:70771-1312-2 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (70771-1312-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204020 05/08/2018
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (70771-1311), ANALYSIS (70771-1312), MANUFACTURE (70771-1311), MANUFACTURE (70771-1312)

Revised: 08/2020 Cadila Healthcare Limited

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