USFDA APPLICATION NUMBER - 20064 / DOSAGE - CAPSULE;ORAL - 75MG;25MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
NITROFURANTOIN MONOHYDRATE(UNII: E1QI2CQQ1I) (NITROFURANTOIN - UNII:927AH8112L) | NITROFURANTOIN | 75mg |
NITROFURANTOIN(UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L) | NITROFURANTOIN | 25mg |
Inactive Ingredients
Ingredient Name | AvKARE, Inc. | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | Preferred Pharmaceuticals Inc. | REMEDYREPACK INC. | St. Mary's Medical Park Pharmacy | Avera McKennan Hospital | Mylan Institutional Inc. | Mylan Pharmaceuticals Inc. | NuCare Pharmaceuticals, Inc. | REMEDYREPACK INC. | Actavis Pharma, Inc. | A-S Medication Solutions | American Health Packaging | BluePoint Laboratories | Bryant Ranch Prepack | Preferred Pharmaceuticals, Inc. |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
ALCOHOL(3K9958V90M) | ||||||||||||||||
ALGINIC ACID(8C3Z4148WZ) | ||||||||||||||||
AMMONIA(5138Q19F1X) | ||||||||||||||||
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J) | ||||||||||||||||
BUTYL ALCOHOL(8PJ61P6TS3) | ||||||||||||||||
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J) | ||||||||||||||||
CARBOMER 934(Z135WT9208) | ||||||||||||||||
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)(F68VH75CJC) | ||||||||||||||||
CARBOMER HOMOPOLYMER TYPE A(F68VH75CJC) | ||||||||||||||||
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)(K6MOM3T5YL) | ||||||||||||||||
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)(Z135WT9208) | ||||||||||||||||
CARBOXYMETHYLCELLULOSE(05JZI7B19X) | ||||||||||||||||
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||||||||||||
D&C RED NO. 28(767IP0Y5NH) | ||||||||||||||||
D&C YELLOW NO. 10(35SW5USQ3G) | ||||||||||||||||
FD&C BLUE NO. 1(H3R47K3TBD) | ||||||||||||||||
FD&C BLUE NO. 2(L06K8R7DQK) | ||||||||||||||||
FD&C RED NO. 3(PN2ZH5LOQY) | ||||||||||||||||
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) | ||||||||||||||||
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||||||||||||
HYPROMELLOSES(3NXW29V3WO) | ||||||||||||||||
ISOPROPYL ALCOHOL(ND2M416302) | ||||||||||||||||
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||||||||||||
LACTOSE(J2B2A4N98G) | ||||||||||||||||
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) | ||||||||||||||||
MAGNESIUM STEARATE(70097M6I30) | ||||||||||||||||
MALTODEXTRIN(7CVR7L4A2D) | ||||||||||||||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||||||||||||
POTASSIUM HYDROXIDE(WZH3C48M4T) | ||||||||||||||||
POVIDONE(FZ989GH94E) | ||||||||||||||||
POVIDONE, UNSPECIFIED(FZ989GH94E) | ||||||||||||||||
POVIDONES(FZ989GH94E) | ||||||||||||||||
PROPYLENE GLYCOL(6DC9Q167V3) | ||||||||||||||||
SHELLAC(46N107B71O) | ||||||||||||||||
SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||||||||||||
SODIUM ALGINATE(C269C4G2ZQ) | ||||||||||||||||
SODIUM HYDROXIDE(55X04QC32I) | ||||||||||||||||
SODIUM LAURYL SULFATE(368GB5141J) | ||||||||||||||||
STARCH, CORN(O8232NY3SJ) | ||||||||||||||||
SUCROSE(C151H8M554) | ||||||||||||||||
TALC(7SEV7J4R1U) | ||||||||||||||||
TITANIUM DIOXIDE(15FIX9V2JP) | ||||||||||||||||
WATER(059QF0KO0R) |
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