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USFDA APPLICATION NUMBER - 16620 / DOSAGE - CAPSULE;ORAL - 100MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| NITROFURANTOIN(UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L) | NITROFURANTOIN | 50mg |
Inactive Ingredients
| Ingredient Name | REMEDYREPACK INC. | American Health Packaging | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | Liberty Pharmaceuticals, Inc. | NuCare Pharmaceuticals,Inc. | NCS HealthCare of KY, Inc dba Vangard Labs | Lake Erie Medical DBA Quality Care Products LLC | PD-Rx Pharmaceuticals, Inc. | Teva Pharmaceuticals USA, Inc. | Unit Dose Services | A-S Medication Solutions | A-S Medication Solutions LLC | BluePoint Laboratories | Bryant Ranch Prepack | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | Mylan Institutional Inc. | Mylan Pharmaceuticals Inc. | NuCare Pharmaceuticals, Inc. | Preferred Pharmaceuticals Inc. | REMEDYREPACK INC. | NuCare Pharmaceuticals Industries, Inc. |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALGINIC ACID(8C3Z4148WZ) | |||||||||||||||||||||
| ALUMINUM OXIDE(LMI26O6933) | |||||||||||||||||||||
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J) | |||||||||||||||||||||
| ANHYDROUS LACTOSE(3SY5LH9PMK) | |||||||||||||||||||||
| BUTYL ALCOHOL(8PJ61P6TS3) | |||||||||||||||||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||||||||||||
| D&C RED NO. 33(9DBA0SBB0L) | |||||||||||||||||||||
| 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) | |||||||||||||||||||||
| INDIGOTINDISULFONATE SODIUM(D3741U8K7L) | |||||||||||||||||||||
| 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) |
