ELETRIPTAN HYDROBROMIDE - eletriptan hydrobromide tablet, film coated 
Zydus Lifesciences Limited

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ELETRIPTAN HYDROBROMIDE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eletriptan hydrobromide Tablets, 20 mg

NDC 70771-1107-3

Rx only

30 Tablets

ELETRIPTAN HYDROBROMIDE TABLET

Eletriptan hydrobromide Tablets, 40 mg

NDC 70771-1108-3

Rx only

30 Tablets

Eletriptan hydrobromide tablet
ELETRIPTAN HYDROBROMIDE 
eletriptan hydrobromide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1107
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ELETRIPTAN HYDROBROMIDE (UNII: M41W832TA3) (ELETRIPTAN - UNII:22QOO9B8KI) ELETRIPTAN20 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE 112 (UNII: X7XJ6RM9Q2)  
POVIDONE K30 (UNII: U725QWY32X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorORANGE (ORANGE TO MOTTLED ORANGE) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code 922
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1107-330 in 1 BOTTLE; Type 0: Not a Combination Product07/12/2017
2NDC:70771-1107-01000 in 1 BOTTLE; Type 0: Not a Combination Product07/12/2017
3NDC:70771-1107-410 in 1 CARTON07/12/2017
3NDC:70771-1107-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:70771-1107-61 in 1 CARTON07/12/2017
46 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20640907/12/2017
ELETRIPTAN HYDROBROMIDE 
eletriptan hydrobromide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1108
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ELETRIPTAN HYDROBROMIDE (UNII: M41W832TA3) (ELETRIPTAN - UNII:22QOO9B8KI) ELETRIPTAN40 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE 112 (UNII: X7XJ6RM9Q2)  
POVIDONE K30 (UNII: U725QWY32X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorBROWN (BROWN) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code 923
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1108-330 in 1 BOTTLE; Type 0: Not a Combination Product07/12/2017
2NDC:70771-1108-5500 in 1 BOTTLE; Type 0: Not a Combination Product07/12/2017
3NDC:70771-1108-410 in 1 CARTON07/12/2017
3NDC:70771-1108-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:70771-1108-61 in 1 CARTON07/12/2017
46 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20640907/12/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1107, 70771-1108) , MANUFACTURE(70771-1107, 70771-1108)

Revised: 8/2022
Document Id: 84ad48e6-e0f6-46ae-80b4-3784d8b8dd7a
Set id: 481ae7d4-9e57-424a-9d07-2920954b6ddc
Version: 6
Effective Time: 20220825
 
Zydus Lifesciences Limited