ERLOTINIB HYDROCHLORIDE (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 25 mg

NDC 62332-565-30
Erlotinib Tablets
25 mg
Rx only
30 Tablets
Alembic

30 Tablets
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 100 mg

NDC 62332-566-30

Erlotinib Tablets

100 mg

Rx only

30 Tablets

Alembic

30 Tablets
(click image for full-size original)

30 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 150 mg

NDC 62332-567-30

Erlotinib Tablets

150 mg

Rx only

30 Tablets

Alembic

30 Tablets
(click image for full-size original)

ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-565
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
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 5mm
Flavor Imprint Code L55
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-565-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:62332-565-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214719 07/09/2021
ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-566
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
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code L630
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-566-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:62332-566-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214719 07/09/2021
ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-567
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
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex) Size 10mm
Flavor Imprint Code L631
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-567-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:62332-567-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214719 07/09/2021
Labeler — Alembic Pharmaceuticals Inc. (079288842)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 675480402 MANUFACTURE (62332-565), MANUFACTURE (62332-566), MANUFACTURE (62332-567)

Revised: 07/2021 Alembic Pharmaceuticals Inc.

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