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USFDA APPLICATION NUMBER - 21437 / DOSAGE - TABLET;ORAL - 50MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| EPLERENONE(UNII: 6995V82D0B) (EPLERENONE - UNII:6995V82D0B) | EPLERENONE | 25mg |
Inactive Ingredients
| Ingredient Name | Apotex Corp | Avera McKennan Hospital | American Health Packaging | Mylan Pharmaceuticals Inc. | Slate Run Pharmaceuticals, LLC | Upsher-Smith Laboratories, LLC |
|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | ||||||
| FD&C YELLOW NO. 5(I753WB2F1M) | ||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | ||||||
| FERRIC OXIDE RED(1K09F3G675) | ||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||
| HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | ||||||
| HYPROMELLOSE 2208 (15000 MPA.S)(Z78RG6M2N2) | ||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||
| HYPROMELLOSES(3NXW29V3WO) | ||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||
| LACTOSE(J2B2A4N98G) | ||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||
| POLYDEXTROSE(VH2XOU12IE) | ||||||
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | ||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | ||||||
| POLYSORBATE 80(6OZP39ZG8H) | ||||||
| POVIDONE K30(U725QWY32X) | ||||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||||
| TALC(7SEV7J4R1U) | ||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | ||||||
| TRIACETIN(XHX3C3X673) |
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