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USFDA APPLICATION NUMBER - 20859 / DOSAGE - CAPSULE;ORAL - 5MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| METAXALONE(UNII: 1NMA9J598Y) (METAXALONE - UNII:1NMA9J598Y) | METAXALONE | 800mg |
Inactive Ingredients
| Ingredient Name | St. Marys Medical Park Pharmacy | A-S Medication Solutions | Lake Erie Medical DBA Quality Care Products LLC | Teva Pharmaceuticals USA, Inc. | Unit Dose Services | PD-Rx Pharmaceuticals, Inc. | A-S Medication Solutions LLC | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | Northstar Rx LLC | St Marys Medical Park Pharmacy | Bryant Ranch Prepack | Upsher-Smith Laboratories, Inc. | Preferred Pharmaceuticals Inc. |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALGINIC ACID(8C3Z4148WZ) | |||||||||||||
| ALUMINUM OXIDE(LMI26O6933) | |||||||||||||
| ANHYDROUS LACTOSE(3SY5LH9PMK) | |||||||||||||
| CALCIUM(SY7Q814VUP) | |||||||||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||||||||||||
| FD&C Blue No. 2(L06K8R7DQK) | |||||||||||||
| FD&C GREEN NO. 3(3P3ONR6O1S) | |||||||||||||
| FD&C RED NO. 40(WZB9127XOA) | |||||||||||||
| FD&C YELLOW NO. 5(I753WB2F1M) | |||||||||||||
| FERRIC OXIDE RED(1K09F3G675) | |||||||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||||||||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | |||||||||||||
| GELATIN(2G86QN327L) | |||||||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | |||||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||||
| LACTOSE(J2B2A4N98G) | |||||||||||||
| LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) | |||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||||||
| microcrystalline cellulose(OP1R32D61U) | |||||||||||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | |||||||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||||||||||||
| SHELLAC(46N107B71O) | |||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | |||||||||||||
| STARCH, CORN(O8232NY3SJ) | |||||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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