Last Updated: May 14, 2026

List of Excipients in API nitrofurantoin monohydrate


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Excipients in NDA-approved (novel) drugs containing nitrofurantoin monohydrate

Glossary
Company Tradename Ingredient NDC Excipient Potential Generic Entry
PharmPak, Inc. NITROFURANTOIN MONO nitrofurantoin monohydrate 54348-849 CARBOMER HOMOPOLYMER TYPE B
PharmPak, Inc. NITROFURANTOIN MONO nitrofurantoin monohydrate 54348-849 D&C YELLOW NO. 10
PharmPak, Inc. NITROFURANTOIN MONO nitrofurantoin monohydrate 54348-849 FD&C BLUE NO. 1
PharmPak, Inc. NITROFURANTOIN MONO nitrofurantoin monohydrate 54348-849 FD&C RED NO. 40
>Company >Tradename >Ingredient >NDC >Excipient >Potential Generic Entry

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Excipients in ANDA-approved (generic) drugs containing nitrofurantoin monohydrate

Company Ingredient NDC Excipient
Mylan Pharmaceuticals Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 0378-3422 ALGINIC ACID
Mylan Pharmaceuticals Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 0378-3422 ANHYDROUS DIBASIC CALCIUM PHOSPHATE
Mylan Pharmaceuticals Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 0378-3422 CELLULOSE, MICROCRYSTALLINE
Mylan Pharmaceuticals Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 0378-3422 D&C YELLOW NO. 10
>Company >Ingredient >NDC >Excipient

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Detailed excipient profiles for nitrofurantoin monohydrate

Excipient focus: ALCOHOL

Excipient focus: ALGINIC ACID

Excipient focus: AMMONIA

Excipient focus: ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Excipient focus: BUTYL ALCOHOL

Excipient focus: CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

nitrofurantoin monohydrate drug variants not containing CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

Company Ingredient NDC
PharmPak, Inc. nitrofurantoin monohydrate 54348-849
Direct_Rx nitrofurantoin monohydrate 61919-021
Mylan Pharmaceuticals Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 0378-3422
Central Texas Community Health Centers nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 76413-115
>Company >Ingredient >NDC

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Excipient focus: CARBOMER 934

nitrofurantoin monohydrate drug variants not containing CARBOMER 934

Company Ingredient NDC
PharmPak, Inc. nitrofurantoin monohydrate 54348-849
Mylan Pharmaceuticals Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 0378-3422
Physicians Total Care Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 54868-6203
Central Texas Community Health Centers nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 76413-115
>Company >Ingredient >NDC

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Excipient focus: CARBOMER HOMOPOLYMER TYPE B

nitrofurantoin monohydrate drug variants not containing CARBOMER HOMOPOLYMER TYPE B

Company Ingredient NDC
Mylan Pharmaceuticals Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 0378-3422
Physicians Total Care Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 54868-6203
Central Texas Community Health Centers nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 76413-115
RedPharm Drug, Inc. nitrofurantoin monohydrate/ macrocrystalline 67296-0737
>Company >Ingredient >NDC

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Excipient focus: CARBOXYMETHYLCELLULOSE

Excipient focus: CELLULOSE, MICROCRYSTALLINE

Excipient focus: CROSPOVIDONE

Excipient focus: D&C YELLOW NO. 10

Excipient focus: FD&C BLUE NO. 1

Excipient focus: FD&C BLUE NO. 2

Excipient focus: FD&C RED NO. 40

Excipient focus: FD&C YELLOW NO. 6

Excipient focus: FERRIC OXIDE RED

Excipient focus: FERRIC OXIDE YELLOW

nitrofurantoin monohydrate drug variants containing FERRIC OXIDE YELLOW

Company Ingredient NDC
Mylan Pharmaceuticals Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 0378-3422
Physicians Total Care Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 54868-6203
Central Texas Community Health Centers nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 76413-115
AvKARE nitrofurantoin monohydrate/macrocrystals 42291-574
>Company >Ingredient >NDC

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Excipient focus: FERROSOFERRIC OXIDE

nitrofurantoin monohydrate drug variants containing FERROSOFERRIC OXIDE

Company Ingredient NDC
Mylan Pharmaceuticals Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 0378-3422
Physicians Total Care Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 54868-6203
Central Texas Community Health Centers nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 76413-115
AvKARE nitrofurantoin monohydrate/macrocrystals 42291-574
>Company >Ingredient >NDC

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Excipient focus: GELATIN

Excipient focus: HYPROMELLOSE

Excipient focus: HYPROMELLOSES

Excipient focus: ISOPROPYL ALCOHOL

Excipient focus: LACTOSE

Excipient focus: LACTOSE MONOHYDRATE

Excipient focus: MAGNESIUM STEARATE

Excipient focus: MALTODEXTRIN

Excipient focus: POTASSIUM HYDROXIDE

Excipient focus: POVIDONE

nitrofurantoin monohydrate drug variants not containing POVIDONE

Company Ingredient NDC
Mylan Pharmaceuticals Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 0378-3422
Physicians Total Care Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 54868-6203
Central Texas Community Health Centers nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 76413-115
Aidarex Pharmaceuticals LLC nitrofurantoin monohydrate/macrocrystalline 33261-160
>Company >Ingredient >NDC

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Excipient focus: POVIDONES

Excipient focus: PROPYLENE GLYCOL

nitrofurantoin monohydrate drug variants containing PROPYLENE GLYCOL

Company Ingredient NDC
Mylan Pharmaceuticals Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 0378-3422
Physicians Total Care Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 54868-6203
Central Texas Community Health Centers nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 76413-115
AvKARE nitrofurantoin monohydrate/macrocrystals 42291-574
>Company >Ingredient >NDC

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Excipient focus: SHELLAC

nitrofurantoin monohydrate drug variants containing SHELLAC

Company Ingredient NDC
Mylan Pharmaceuticals Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 0378-3422
Physicians Total Care Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 54868-6203
Central Texas Community Health Centers nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 76413-115
AvKARE nitrofurantoin monohydrate/macrocrystals 42291-574
>Company >Ingredient >NDC

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Excipient focus: SODIUM ALGINATE

Excipient focus: SODIUM HYDROXIDE

Excipient focus: SODIUM LAURYL SULFATE

nitrofurantoin monohydrate drug variants containing SODIUM LAURYL SULFATE

Company Ingredient NDC
Mylan Pharmaceuticals Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 0378-3422
Physicians Total Care Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 54868-6203
Central Texas Community Health Centers nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 76413-115
AvKARE nitrofurantoin monohydrate/macrocrystals 42291-574
>Company >Ingredient >NDC

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Excipient focus: STARCH, CORN

Excipient focus: SUCROSE

nitrofurantoin monohydrate drug variants not containing SUCROSE

Company Ingredient NDC
Mylan Pharmaceuticals Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 0378-3422
Physicians Total Care Inc nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 54868-6203
Central Texas Community Health Centers nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline 76413-115
RedPharm Drug, Inc. nitrofurantoin monohydrate/ macrocrystalline 67296-0737
>Company >Ingredient >NDC

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Excipient focus: TALC

Excipient focus: TITANIUM DIOXIDE

Excipient focus: WATER

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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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