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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. | REMEDYREPACK 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) |
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