Eletriptan Hydrobromide

ELETRIPTAN HYDROBROMIDE- eletriptan hydrobromide tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eletriptan hydrobromide Tablets, 20 mg

NDC 70771-1107-3

Rx only

30 Tablets

Eletriptan hydrobromide Tablets, 40 mg

NDC 70771-1108-3

Rx only

30 Tablets

ELETRIPTAN HYDROBROMIDE eletriptan hydrobromide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1107 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELETRIPTAN HYDROBROMIDE (ELETRIPTAN) ELETRIPTAN 20 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C BLUE NO. 2–ALUMINUM LAKE FD&C YELLOW NO. 6 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 112 POVIDONE K30 TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color ORANGE (ORANGE TO MOTTLED ORANGE) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code 922 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70771-1107-3 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:70771-1107-0 1000 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:70771-1107-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1107-2) 3 NDC:70771-1107-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1107-4) 4 NDC:70771-1107-6 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 4 6 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1107-6)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206409 07/12/2017

ELETRIPTAN HYDROBROMIDE eletriptan hydrobromide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1108 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELETRIPTAN HYDROBROMIDE (ELETRIPTAN) ELETRIPTAN 40 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 112 POVIDONE K30 TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color BROWN (BROWN) Score no score Shape ROUND (ROUND) Size 8mm Flavor Imprint Code 923 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70771-1108-3 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:70771-1108-5 500 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:70771-1108-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1108-2) 3 NDC:70771-1108-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1108-4) 4 NDC:70771-1108-6 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 4 6 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1108-6)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206409 07/12/2017

Labeler — Cadila Healthcare Limited (918596198)

Registrant — Cadila Healthcare Limited (918596198)

Establishment
Name	Address	ID/FEI	Operations
Cadila Healthcare Limited		863362789	ANALYSIS (70771-1107), ANALYSIS (70771-1108), MANUFACTURE (70771-1107), MANUFACTURE (70771-1108)

Revised: 08/2020 Cadila Healthcare Limited