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USFDA APPLICATION NUMBER - 13217 / DOSAGE - TABLET;ORAL - 800MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| Metaxalone(UNII: 1NMA9J598Y) (Metaxalone - UNII:1NMA9J598Y) | Metaxalone | 800mg |
Inactive Ingredients
| Ingredient Name | Preferred Pharmaceuticals Inc. | St. Mary's Medical Park Pharmacy | Unit Dose Services | A-S Medication Solutions | Bryant Ranch Prepack | American Health Packaging | AvKARE | BluePoint Laboratories | Clinical Solutions Wholesale | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | Gemini Laboratories, LLC | Lake Erie Medical DBA Quality Care Products LLC | Preferred Pharmaceuticals, Inc. | Solis Generic Pharmaceuticals LLC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ACACIA(5C5403N26O) | ||||||||||||||
| ALGINIC ACID(8C3Z4148WZ) | ||||||||||||||
| AMMONIUM ALGINATE(Q9QKJ39Q3X) | ||||||||||||||
| CALCIUM ALGINATE(8P20S56HZI) | ||||||||||||||
| CALCIUM CARBONATE(H0G9379FGK) | ||||||||||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||||||||||
| COPOVIDONE K25-31(D9C330MD8B) | ||||||||||||||
| FD&C RED NO. 40(WZB9127XOA) | ||||||||||||||
| FERRIC OXIDE RED(1K09F3G675) | ||||||||||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||||||||||
| HYPROMELLOSES(3NXW29V3WO) | ||||||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||||||||||
| POVIDONE(FZ989GH94E) | ||||||||||||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | ||||||||||||||
| POVIDONES(FZ989GH94E) | ||||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||||||||||
| SODIUM ALGINATE(C269C4G2ZQ) | ||||||||||||||
| SODIUM STARCH GLYCOLATE TYPE A CORN(AG9B65PV6B) | ||||||||||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | ||||||||||||||
| SODIUM STEARYL FUMARATE(7CV7WJK4UI) | ||||||||||||||
| STARCH, CORN(O8232NY3SJ) |
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