Eletriptan Hydrobromide (Page 6 of 6)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-20 mg (1×6) Carton

NDC 59651-104-69
Rx only
Eletriptan Hydrobromide Tablets
20 mg * AUROBINDO 6 (1 x 6) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-20 mg (1x6) Carton
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg (1×6) Carton

NDC 59651-105-69
Rx only
Eletriptan Hydrobromide Tablets
40 mg * AUROBINDO 6 (1 x 6) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 40 mg (1x6) Carton
(click image for full-size original)
ELETRIPTAN HYDROBROMIDE eletriptan hydrobromide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-104
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
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 112
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color ORANGE Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code EL;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-104-69 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (59651-104-06)
1 NDC:59651-104-06 6 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (59651-104-69)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210708 01/15/2019
ELETRIPTAN HYDROBROMIDE eletriptan hydrobromide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-105
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
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 112
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color ORANGE Score no score
Shape ROUND (biconvex) Size 8mm
Flavor Imprint Code EL;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-105-69 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (59651-105-06)
1 NDC:59651-105-06 6 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (59651-105-69)
2 NDC:59651-105-93 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 6 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (59651-105-93)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210708 02/16/2018
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650918514 ANALYSIS (59651-104), ANALYSIS (59651-105), MANUFACTURE (59651-104), MANUFACTURE (59651-105)

Revised: 05/2020 Aurobindo Pharma Limited

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