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USFDA APPLICATION NUMBER - 16620 / DOSAGE - CAPSULE;ORAL - 25MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| NITROFURANTOIN(UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L) | NITROFURANTOIN | 50mg |
Inactive Ingredients
| Ingredient Name | REMEDYREPACK INC. | A-S Medication Solutions | American Health Packaging | BluePoint Laboratories | Bryant Ranch Prepack | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | Lake Erie Medical DBA Quality Care Products LLC | Mylan Institutional Inc. | Mylan Pharmaceuticals Inc. | NuCare Pharmaceuticals, Inc. | PD-Rx Pharmaceuticals, Inc. | Preferred Pharmaceuticals Inc. | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | NuCare Pharmaceuticals Industries, Inc. | REMEDYREPACK INC. |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALGINIC ACID(8C3Z4148WZ) | |||||||||||||||
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J) | |||||||||||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||||||||||||||
| DIPROPYLENE GLYCOL(E107L85C40) | |||||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||||||||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | |||||||||||||||
| 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) | |||||||||||||||
| HYDRATED SILICA(Y6O7T4G8P9) | |||||||||||||||
| HYPROMELLOSES(3NXW29V3WO) | |||||||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||||||
| LACTOSE(J2B2A4N98G) | |||||||||||||||
| LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) | |||||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||||||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | |||||||||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||||||||||||||
| SHELLAC(46N107B71O) | |||||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | |||||||||||||||
| STARCH, CORN(O8232NY3SJ) | |||||||||||||||
| TALC(7SEV7J4R1U) | |||||||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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