EVEROLIMUS (Page 9 of 9)

PRINCIPAL DISPLAY PANEL

Package Label – 2.5 mg

Rx Only NDC 70377-010-22

Everolimus Tablets 2.5 mg

Each tablet contains 2.5 mg everolimus

28 Tablets

Carton contains 4 individual blister cards of 7 tablets.

PRINCIPAL DISPLAY PANEL Package Label 2.5 mg Rx Only		NDC 70377-010-22 Everolimus Tablets Each tablet contains 2.5 mg everolimus 28 Tablets Carton contains 4 individual blister cards of 7 tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Package Label – 5 mg

Rx Only NDC 70377-011-22

Everolimus Tablets 5 mg

Each tablet contains 5 mg everolimus

28 Tablets

Carton contains 4 individual blister cards of 7 tablets.

PRINCIPAL DISPLAY PANEL Package Label 5 mg Rx Only		NDC 70377-011-22 Everolimus Tablets Each tablet contains 5 mg everolimus 28 Tablets Carton contains 4 individual blister cards of 7 tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Package Label – 7.5 mg

Rx Only NDC 70377-012-22

Everolimus Tablets

Each tablet contains 7.5 mg everolimus

28 Tablets

Carton contains 4 individual blister cards of 7 tablets.

PRINCIPAL DISPLAY PANEL Package Label 7.5 mg Rx Only		NDC 70377-012-22  Everolimus Tablets Each tablet contains 7.5 mg everolimus 28 Tablets Carton contains 4 individual blister cards of 7 tablets.
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Package Label – 10 mg

Rx Only NDC 70377-013-22

Everolimus Tablets

Each tablet contains 10 mg everolimus

28 Tablets

Carton contains 4 individual blister cards of 7 tablets.

PRINCIPAL DISPLAY PANEL Package Label 10 mg Rx Only		NDC 70377-13-22 Everolimus Tablets Each tablet contains10 mg everolimus 28 Tablets Carton contains 4 individual blister cards of 7 tablets
(click image for full-size original)
EVEROLIMUS everolimus tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-010
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Everolimus (Everolimus) Everolimus 2.5 mg
Inactive Ingredients
Ingredient Name Strength
Butylated Hydroxytoluene
Anhydrous Lactose
Hypromellose 2208 (3 Mpa.S)
Magnesium Stearate
Lactose Monohydrate
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE (flat faced beveled edge) Size 10mm
Flavor Imprint Code B2;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-010-22 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70377-010-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214182 10/01/2021
EVEROLIMUS everolimus tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-011
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Everolimus (Everolimus) Everolimus 5 mg
Inactive Ingredients
Ingredient Name Strength
Butylated Hydroxytoluene
Anhydrous Lactose
Hypromellose 2208 (3 Mpa.S)
Magnesium Stearate
Lactose Monohydrate
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE (flat faced beveled edge) Size 12mm
Flavor Imprint Code B5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-011-22 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70377-011-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214182 10/01/2021
EVEROLIMUS everolimus tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-012
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Everolimus (Everolimus) Everolimus 7.5 mg
Inactive Ingredients
Ingredient Name Strength
Anhydrous Lactose
Magnesium Stearate
Hypromellose 2208 (3 Mpa.S)
Butylated Hydroxytoluene
Lactose Monohydrate
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE (flat faced beveled edge) Size 15mm
Flavor Imprint Code B7;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-012-22 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70377-012-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214182 10/01/2021
EVEROLIMUS everolimus tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-013
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Everolimus (Everolimus) Everolimus 10 mg
Inactive Ingredients
Ingredient Name Strength
Anhydrous Lactose
Lactose Monohydrate
Magnesium Stearate
Butylated Hydroxytoluene
Hypromellose 2208 (3 Mpa.S)
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE (flat faced beveled edge) Size 17mm
Flavor Imprint Code B10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-013-22 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70377-013-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214182 10/01/2021
Labeler — Biocon Pharma Inc. (080000063)
Registrant — Biocon Pharma Limited (871412155)
Establishment
Name Address ID/FEI Operations
Biocon Limited 915076162 api manufacture (70377-010), api manufacture (70377-011), api manufacture (70377-012), api manufacture (70377-013)
Establishment
Name Address ID/FEI Operations
Biocon Pharma Limited 871412155 manufacture (70377-010), manufacture (70377-011), manufacture (70377-012), manufacture (70377-013)

Revised: 03/2022 Biocon Pharma Inc.

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