
USFDA APPLICATION NUMBER - 50405 / DOSAGE - CAPSULE;ORAL - EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| CEPHALEXIN(UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677) | CEPHALEXIN ANHYDROUS | 750mg | 500mg | 250mg |
Inactive Ingredients
| Ingredient Name | Pragma Pharmaceuticals, LLC | Shionogi Inc. | Fera Pharmaceuticals, LLC |
|---|---|---|---|
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311) | |||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(K679OBS311) | |||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||
| DIMETHICONE(92RU3N3Y1O) | |||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||
| FD&C YELLOW NO. 6(H77VEI93A8) | |||
| GELATIN(2G86QN327L) | |||
| GELATIN, UNSPECIFIED(2G86QN327L) | |||
| MAGNESIUM STEARATE(70097M6I30) | |||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||
| TITANIUM DIOXIDE(15FIX9V2JP) |