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USFDA APPLICATION NUMBER - 18029 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49) | METHYLPHENIDATE HYDROCHLORIDE | 20mg | 5mg | 20mg | 10mg |
Inactive Ingredients
| Ingredient Name | Sandoz Inc |
|---|---|
| CETOSTEARYL ALCOHOL(2DMT128M1S) | |
| D&C YELLOW NO. 10(35SW5USQ3G) | |
| FD&C GREEN NO. 3(3P3ONR6O1S) | |
| LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) | |
| MAGNESIUM STEARATE(70097M6I30) | |
| METHYL ALCOHOL(Y4S76JWI15) | |
| MINERAL OIL(T5L8T28FGP) | |
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |
| POVIDONE, UNSPECIFIED(FZ989GH94E) | |
| SUCROSE(C151H8M554) | |
| TALC(7SEV7J4R1U) | |
| TITANIUM DIOXIDE(15FIX9V2JP) | |
| TRAGACANTH(2944357O2O) | |
| ZEIN(80N308T1NN) |
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