ERLOTINIB tablet, film coated

Erlotinib by

Drug Labeling and Warnings

Erlotinib by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Erlotinib Tablets, 25 mg

30 tablets

NDC: 70771-1521-3

Rx only

Erlotinib Tablets, 100 mg

30 tablets

NDC: 70771-1522-3

Rx only

Erlotinib Tablets, 150 mg

30 tablets

NDC: 70771-1523-3

Rx only

INGREDIENTS AND APPEARANCE

ERLOTINIB 
erlotinib tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1521
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ERLOTINIB HYDROCHLORIDE (UNII: DA87705X9K) (ERLOTINIB - UNII:J4T82NDH7E)	ERLOTINIB	25 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (Off-white)	Score	no score
Shape	ROUND (Round)	Size	6mm
Flavor		Imprint Code	913
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1521-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020
2	NDC: 70771-1521-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020
3	NDC: 70771-1521-7	3 in 1 CARTON	04/30/2020
3	NDC: 70771-1521-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213065	04/30/2020

ERLOTINIB 
erlotinib tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1522
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ERLOTINIB HYDROCHLORIDE (UNII: DA87705X9K) (ERLOTINIB - UNII:J4T82NDH7E)	ERLOTINIB	100 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (Off-white)	Score	no score
Shape	ROUND (Round)	Size	9mm
Flavor		Imprint Code	914
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1522-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020
2	NDC: 70771-1522-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020
3	NDC: 70771-1522-7	3 in 1 CARTON	04/30/2020
3	NDC: 70771-1522-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213065	04/30/2020

ERLOTINIB 
erlotinib tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1523
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ERLOTINIB HYDROCHLORIDE (UNII: DA87705X9K) (ERLOTINIB - UNII:J4T82NDH7E)	ERLOTINIB	150 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (Off-white)	Score	no score
Shape	ROUND (Round)	Size	11mm
Flavor		Imprint Code	915
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1523-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020
2	NDC: 70771-1523-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020
3	NDC: 70771-1523-7	3 in 1 CARTON	04/30/2020
3	NDC: 70771-1523-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213065	04/30/2020

Labeler - Cadila Healthcare Limited (918596198)

Registrant - Cadila Healthcare Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Cadila Healthcare Limited		863362789	ANALYSIS(70771-1521, 70771-1522, 70771-1523) , MANUFACTURE(70771-1521, 70771-1522, 70771-1523)