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USFDA APPLICATION NUMBER - 200534 / DOSAGE - CAPSULE;ORAL - 5MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570) | OXYCODONE HYDROCHLORIDE | 5mg |
Inactive Ingredients
| Ingredient Name | American Health Packaging | Novel Laboratories, Inc. | Bryant Ranch Prepack | KVK-TECH, INC. |
|---|---|---|---|---|
| ANHYDROUS LACTOSE(3SY5LH9PMK) | ||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||
| FD&C RED NO. 40(WZB9127XOA) | ||||
| FD&C YELLOW NO. 6(H77VEI93A8) | ||||
| FERRIC OXIDE RED(1K09F3G675) | ||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||
| FERROSOFERRIC OXIDE(XM0M87F357) | ||||
| GELATIN(2G86QN327L) | ||||
| GELATIN, UNSPECIFIED(2G86QN327L) | ||||
| LACTOSE(J2B2A4N98G) | ||||
| Lactose, Unspecified Form(J2B2A4N98G) | ||||
| MAGNESIUM STEARATE(70097M6I30) | ||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | ||||
| SHELLAC(46N107B71O) | ||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||
| Sodium Lauryl Sulfate(368GB5141J) | ||||
| Sodium Starch Glycolate Type A Potato(5856J3G2A2) | ||||
| STARCH, CORN(O8232NY3SJ) | ||||
| STEARIC ACID(4ELV7Z65AP) | ||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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