USFDA APPLICATION NUMBER - 21278 / DOSAGE - TABLET;ORAL - 10MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
DEXMETHYLPHENIDATE HYDROCHLORIDE(UNII: 1678OK0E08) (DEXMETHYLPHENIDATE - UNII:M32RH9MFGP) | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10mg | 5mg | 2.5mg |
Inactive Ingredients
Ingredient Name | Avera McKennan Hospital | KVK-TECH, INC | Teva Pharmaceuticals USA, Inc. | Tris Pharma Inc | A-S Medication Solutions LLC | West-ward Pharmaceutical Corp | Neolpharma, Inc. | Sandoz Inc | Sun Pharmaceutical Industries, Inc. | Bryant Ranch Prepack | Golden State Medical Supply, Inc. |
---|---|---|---|---|---|---|---|---|---|---|---|
ALUMINUM OXIDE(LMI26O6933) | |||||||||||
ANHYDROUS LACTOSE(3SY5LH9PMK) | |||||||||||
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||
D&C YELLOW NO. 10(35SW5USQ3G) | |||||||||||
FD&C BLUE NO. 1(H3R47K3TBD) | |||||||||||
FD&C BLUE NO. 2(L06K8R7DQK) | |||||||||||
FD&C RED NO. 3(PN2ZH5LOQY) | |||||||||||
GELATIN(2G86QN327L) | |||||||||||
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||
MAGNESIUM STEARATE(70097M6I30) | |||||||||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||||
SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||
SODIUM LAURYL SULFATE(368GB5141J) | |||||||||||
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | |||||||||||
STARCH, CORN(O8232NY3SJ) | |||||||||||
STARCH, PREGELATINIZED CORN(O8232NY3SJ) | |||||||||||
TALC(7SEV7J4R1U) | |||||||||||
TITANIUM DIOXIDE(15FIX9V2JP) |
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