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 — 100 mg Tablet Bottle Label

NDC 51991-891-33

Erlotinib Tablets

100 mg

Rx Only
30 Tablets

breckenridge
A TowaCompany

PRINCIPAL DISPLAY PANEL — 150 mg Tablet Bottle Label

NDC 51991-892-33

Erlotinib Tablets

150 mg

Rx Only
30 Tablets

breckenridge
A TowaCompany

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.