
USFDA APPLICATION NUMBER - 16620 / DOSAGE - CAPSULE;ORAL - 50MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| NITROFURANTOIN(UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L) | NITROFURANTOIN | 50mg |
Inactive Ingredients
| Ingredient Name | A-S Medication Solutions LLC | Bryant Ranch Prepack | NCS HealthCare of KY, Inc dba Vangard Labs | Teva Pharmaceuticals USA, Inc. | A-S Medication Solutions | American Health Packaging | BluePoint Laboratories | Lake Erie Medical DBA Quality Care Products LLC | Mylan Institutional Inc. | Mylan Pharmaceuticals Inc. | NuCare Pharmaceuticals, Inc. | PD-Rx Pharmaceuticals, Inc. | Preferred Pharmaceuticals Inc. | REMEDYREPACK INC. | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | NuCare Pharmaceuticals Industries, Inc. |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALUMINUM OXIDE(LMI26O6933) | ||||||||||||||||
| ANHYDROUS LACTOSE(3SY5LH9PMK) | ||||||||||||||||
| BUTYL ALCOHOL(8PJ61P6TS3) | ||||||||||||||||
| D&C RED NO. 33(9DBA0SBB0L) | ||||||||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||||||||||||||
| 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) | ||||||||||||||||
| 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) |