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USFDA APPLICATION NUMBER - 20281 / DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| tramadol hydrochloride(UNII: 9N7R477WCK) (tramadol - UNII:39J1LGJ30J) | tramadol hydrochloride | 50mg |
Inactive Ingredients
| Ingredient Name | A-S Medication Solutions | A-S Medication Solutions LLC | Janssen Pharmaceuticals, Inc. | Lake Erie Medical DBA Quality Care Products LLC | PD-Rx Pharmaceuticals, Inc. |
|---|---|---|---|---|---|
| carnauba wax(R12CBM0EIZ) | |||||
| cellulose, microcrystalline(OP1R32D61U) | |||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||||
| hypromelloses(3NXW29V3WO) | |||||
| lactose(J2B2A4N98G) | |||||
| lactose, unspecified form(J2B2A4N98G) | |||||
| magnesium stearate(70097M6I30) | |||||
| microcrystalline cellulose(OP1R32D61U) | |||||
| MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(461P5CJN6T) | |||||
| POLYETHYLENE GLYCOL 400(B697894SGQ) | |||||
| polyethylene glycol, unspecified(3WJQ0SDW1A) | |||||
| polyethylene glycols(3WJQ0SDW1A) | |||||
| polysorbate 80(6OZP39ZG8H) | |||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | |||||
| starch, corn(O8232NY3SJ) | |||||
| titanium dioxide(15FIX9V2JP) |
