Erlotinib (Page 8 of 8)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

25mg Tablets:

25mg-container
(click image for full-size original)
25mg-carton
(click image for full-size original)

100mg Tablets:

100mg-container
(click image for full-size original)
100mg-carton
(click image for full-size original)

150 mg Tablets:

150mg-container
(click image for full-size original)
150mg-carton
(click image for full-size original)

ERLOTINIB
erlotinib tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59923-727
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERLOTINIB HYDROCHLORIDE (ERLOTINIB) ERLOTINIB 150 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
LACTOSE MONOHYDRATE
SODIUM LAURYL SULFATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color white Score no score
Shape ROUND Size 11mm
Flavor Imprint Code S11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59923-727-30 1 BOTTLE in 1 BOX contains a BOTTLE
1 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the BOX (59923-727-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211960 05/01/2020
ERLOTINIB
erlotinib tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59923-725
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERLOTINIB HYDROCHLORIDE (ERLOTINIB) ERLOTINIB 25 mg
Inactive Ingredients
Ingredient Name Strength
TITANIUM DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
SODIUM LAURYL SULFATE
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code S13
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59923-725-30 1 BOTTLE in 1 BOX contains a BOTTLE
1 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the BOX (59923-725-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211960 05/01/2020
ERLOTINIB
erlotinib tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59923-726
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERLOTINIB HYDROCHLORIDE (ERLOTINIB) ERLOTINIB 100 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score no score
Shape ROUND Size 9mm
Flavor Imprint Code S12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59923-726-30 1 BOTTLE in 1 BOX contains a BOTTLE
1 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the BOX (59923-726-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211960 05/01/2020
Labeler — Areva Pharmaceuticals (833189835)
Establishment
Name Address ID/FEI Operations
Shilpa Medicare Limited 650644136 manufacture (59923-725), manufacture (59923-726), manufacture (59923-727)

Revised: 01/2021 Areva Pharmaceuticals

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