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USFDA APPLICATION NUMBER - 21692 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 | 300mg | 100mg |
Inactive Ingredients
| Ingredient Name | Janssen Pharmaceuticals, Inc. | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | Patriot Pharmaceuticals, LLC | REMEDYREPACK INC. |
|---|---|---|---|---|
| dibutyl sebacate(4W5IH7FLNY) | ||||
| ETHYLCELLULOSE (100 MPA.S)(47MLB0F1MV) | ||||
| MAGNESIUM STEARATE(70097M6I30) | ||||
| polyvinyl alcohol(532B59J990) | ||||
| POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | ||||
| POVIDONE(FZ989GH94E) | ||||
| silicon dioxide(ETJ7Z6XBU4) | ||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||
| SODIUM STEARYL FUMARATE(7CV7WJK4UI) | ||||
| STARCH, CORN(O8232NY3SJ) | ||||
| XANTHAN GUM(TTV12P4NEE) |
