Kalliga (Page 11 of 11)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.15 mg/0.03 mg Pouch Label

NDC 65862-887-28
KalligaTM
(Desogestrel and Ethinyl
Estradiol Tablets USP)
0.15 mg/0.03 mg
Each white to off-white tablet contains 0.15 mg desogestrel and
0.03 mg ethinyl estradiol USP. Each green tablet contains inert
ingredients.
Dosage: One tablet daily as prescribed. See package insert.
Rx only 1 Pouch of 28 Tablets
AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 0.15 mg/0.03 mg Pouch Label
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.15 mg/0.03 mg Blister Carton

NDC 65862-887-92
KalligaTM
(Desogestrel and Ethinyl
Estradiol Tablets USP)
0.15 mg/0.03 mg
Each white to off-white tablet contains 0.15 mg desogestrel and 0.03 mg ethinyl
estradiol USP. Each green tablet contains inert ingredients.
Dosage: One tablet daily as prescribed. See package insert.
Rx only 6 Pouches Each Containing 28 Tablets
AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 0.15 mg/0.03 mg Blister Carton
(click image for full-size original)

KALLIGA desogestrel and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-887
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-887-92 6 POUCH in 1 CARTON contains a POUCH (65862-887-28)
1 NDC:65862-887-28 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (65862-887-92) and contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within a POUCH (65862-887-28) and a CARTON (65862-887-92)
2 NDC:65862-887-88 3 POUCH in 1 CARTON contains a POUCH
2 1 BLISTER PACK in 1 POUCH This package is contained within the CARTON (65862-887-88) and contains a BLISTER PACK
2 1 KIT in 1 BLISTER PACK This package is contained within a POUCH and a CARTON (65862-887-88)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
KALLIGA desogestrel and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESOGESTREL (DESOGESTREL) DESOGESTREL 0.15 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.03 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
LACTOSE MONOHYDRATE
STARCH, POTATO
POVIDONE K30
STEARIC ACID
.ALPHA.-TOCOPHEROL
Product Characteristics
Color WHITE (White to off-White) Score no score
Shape ROUND (Biconvex-Beveled Edge) Size 5mm
Flavor Imprint Code S;25
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207081 05/17/2017
Part 2 of 2
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
Product Characteristics
Color GREEN Score no score
Shape ROUND (Mottled, Biconvex, Beveled Edge) Size 5mm
Flavor Imprint Code S;7
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207081 05/17/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207081 05/17/2017
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-887), MANUFACTURE (65862-887)

Revised: 12/2021 Aurobindo Pharma Limited

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