Erlotinib (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 25 mg Tablet Bottle Label

NDC 51991-890-33

Erlotinib Tablets

25 mg

Rx Only
30 Tablets

breckenridge
A TowaCompany

Principal Display Panel -- 25 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Bottle Label

NDC 51991-891-33

Erlotinib Tablets

100 mg

Rx Only
30 Tablets

breckenridge
A TowaCompany

Principal Display Panel -- 100 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 150 mg Tablet Bottle Label

NDC 51991-892-33

Erlotinib Tablets

150 mg

Rx Only
30 Tablets

breckenridge
A TowaCompany

Principal Display Panel -- 150 mg Tablet Bottle Label
(click image for full-size original)
ERLOTINIB erlotinib hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51991-890
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
HYPROMELLOSE, UNSPECIFIED
Lactose monohydrate
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 4000
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND (Biconvex) Size 6mm
Flavor Imprint Code N;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51991-890-33 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208488 11/05/2019 07/31/2025
ERLOTINIB erlotinib hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51991-891
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
HYPROMELLOSE, UNSPECIFIED
Lactose monohydrate
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 4000
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND (Biconvex) Size 9mm
Flavor Imprint Code N;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51991-891-33 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208488 11/05/2019 07/31/2025
ERLOTINIB erlotinib hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51991-892
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
HYPROMELLOSE, UNSPECIFIED
Lactose monohydrate
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 4000
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND (Biconvex) Size 10mm
Flavor Imprint Code N;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51991-892-33 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208488 11/05/2019 07/31/2025
Labeler — Breckenridge Pharmaceutical, Inc. (150554335)
Registrant — Natco Pharma Limited (918588174)
Establishment
Name Address ID/FEI Operations
Natco Pharma Limited 918588174 MANUFACTURE (51991-890), MANUFACTURE (51991-891), MANUFACTURE (51991-892)

Revised: 01/2023 Breckenridge Pharmaceutical, Inc.

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