![FELBAMATE TABLET [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/efa55cb2-b625-4392-9ddb-0a8ad8ee58c4/54e4d1c3-cf8c-4fff-8280-8edcb484c76e-02.jpg)
![FELBAMATE TABLET [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/efa55cb2-b625-4392-9ddb-0a8ad8ee58c4/54e4d1c3-cf8c-4fff-8280-8edcb484c76e-03.jpg)
| NDC | 70771-1077-1, 70771-1077-3, 70771-1077-4, 70771-1077-5, 70771-1077-9, 70771-1078-1, 70771-1078-3, 70771-1078-4, 70771-1078-5, 70771-1078-8, 70771-1078-9 |
| Set ID | efa55cb2-b625-4392-9ddb-0a8ad8ee58c4 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | Anti-epileptic Agent |
| Product Number | |
| Application Number | ANDA208970 |
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FELBAMATE
felbamate tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1077 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FELBAMATE (UNII: X72RBB02N8) (FELBAMATE - UNII:X72RBB02N8) FELBAMATE 400 mg Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FD&C RED NO. 40 (UNII: WZB9127XOA) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (OFF-WHITE TO PALE YELLOW COLOR) Score 2 pieces Shape CAPSULE (CAPSULE) Size 16mm Flavor Imprint Code 10;53 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1077-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/15/2017 2 NDC:70771-1077-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/15/2017 3 NDC:70771-1077-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/15/2017 4 NDC:70771-1077-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/15/2017 5 NDC:70771-1077-4 10 in 1 CARTON 08/15/2017 5 10 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 ANDA208970 08/15/2017 FELBAMATE
felbamate tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1078 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FELBAMATE (UNII: X72RBB02N8) (FELBAMATE - UNII:X72RBB02N8) FELBAMATE 600 mg Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color PINK (LIGHT PINK TO PINK) Score 2 pieces Shape CAPSULE (CAPSULE) Size 19mm Flavor Imprint Code 10;54 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1078-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/15/2017 2 NDC:70771-1078-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/15/2017 3 NDC:70771-1078-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/15/2017 4 NDC:70771-1078-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/15/2017 5 NDC:70771-1078-4 10 in 1 CARTON 08/15/2017 5 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:70771-1078-8 180 in 1 BOTTLE; Type 0: Not a Combination Product 08/15/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208970 08/15/2017 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 863362789 ANALYSIS(70771-1077, 70771-1078) , MANUFACTURE(70771-1077, 70771-1078)
