ERLOTINIB- erlotinib tablet, film coated 
Zydus Lifesciences Limited

----------

Erlotinib Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Erlotinib Tablets, 25 mg

30 tablets

NDC 70771-1521-3

Rx only

25 mg label

Erlotinib Tablets, 100 mg

30 tablets

NDC 70771-1522-3

Rx only

100 mg label

Erlotinib Tablets, 150 mg

30 tablets

NDC 70771-1523-3

Rx only

150 mg label
ERLOTINIB 
erlotinib tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1521
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ERLOTINIB HYDROCHLORIDE (UNII: DA87705X9K) (ERLOTINIB - UNII:J4T82NDH7E) ERLOTINIB25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (Off-white) Scoreno score
ShapeROUND (Round) Size6mm
FlavorImprint Code 913
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1521-330 in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
2NDC:70771-1521-990 in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
3NDC:70771-1521-73 in 1 CARTON04/30/2020
3NDC:70771-1521-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21306504/30/2020
ERLOTINIB 
erlotinib tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1522
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ERLOTINIB HYDROCHLORIDE (UNII: DA87705X9K) (ERLOTINIB - UNII:J4T82NDH7E) ERLOTINIB100 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (Off-white) Scoreno score
ShapeROUND (Round) Size9mm
FlavorImprint Code 914
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1522-330 in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
2NDC:70771-1522-990 in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
3NDC:70771-1522-73 in 1 CARTON04/30/2020
3NDC:70771-1522-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21306504/30/2020
ERLOTINIB 
erlotinib tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1523
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ERLOTINIB HYDROCHLORIDE (UNII: DA87705X9K) (ERLOTINIB - UNII:J4T82NDH7E) ERLOTINIB150 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (Off-white) Scoreno score
ShapeROUND (Round) Size11mm
FlavorImprint Code 915
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1523-330 in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
2NDC:70771-1523-990 in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
3NDC:70771-1523-73 in 1 CARTON04/30/2020
3NDC:70771-1523-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21306504/30/2020
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1521, 70771-1522, 70771-1523) , MANUFACTURE(70771-1521, 70771-1522, 70771-1523)

Revised: 11/2024
Document Id: 9d253beb-cd1f-45df-9b23-c521269d419f
Set id: daaa1329-3a3f-439c-b13d-b301daa234d4
Version: 3
Effective Time: 20241128
 
Zydus Lifesciences Limited