![ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/481ae7d4-9e57-424a-9d07-2920954b6ddc/8cbfff26-bdf1-425c-a96c-e32c82c0934f-04.jpg)
![ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/481ae7d4-9e57-424a-9d07-2920954b6ddc/8cbfff26-bdf1-425c-a96c-e32c82c0934f-05.jpg)
| NDC | 70771-1107-0, 70771-1107-2, 70771-1107-3, 70771-1107-4, 70771-1107-6, 70771-1108-2, 70771-1108-3, 70771-1108-4, 70771-1108-5, 70771-1108-6 |
| Set ID | 481ae7d4-9e57-424a-9d07-2920954b6ddc |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA206409 |
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ELETRIPTAN HYDROBROMIDE
eletriptan hydrobromide tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1107 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELETRIPTAN HYDROBROMIDE (UNII: M41W832TA3) (ELETRIPTAN - UNII:22QOO9B8KI) ELETRIPTAN 20 mg Inactive Ingredients Ingredient Name Strength 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 Color ORANGE (ORANGE TO MOTTLED ORANGE) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code 922 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1107-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/12/2017 2 NDC:70771-1107-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/12/2017 3 NDC:70771-1107-4 10 in 1 CARTON 07/12/2017 3 NDC:70771-1107-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:70771-1107-6 1 in 1 CARTON 07/12/2017 4 6 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 ANDA206409 07/12/2017 ELETRIPTAN HYDROBROMIDE
eletriptan hydrobromide tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1108 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELETRIPTAN HYDROBROMIDE (UNII: M41W832TA3) (ELETRIPTAN - UNII:22QOO9B8KI) ELETRIPTAN 40 mg Inactive Ingredients Ingredient Name Strength 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 Color BROWN (BROWN) Score no score Shape ROUND (ROUND) Size 8mm Flavor Imprint Code 923 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1108-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/12/2017 2 NDC:70771-1108-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/12/2017 3 NDC:70771-1108-4 10 in 1 CARTON 07/12/2017 3 NDC:70771-1108-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:70771-1108-6 1 in 1 CARTON 07/12/2017 4 6 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 ANDA206409 07/12/2017 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 863362789 ANALYSIS(70771-1107, 70771-1108) , MANUFACTURE(70771-1107, 70771-1108)
