MedPath
FDA Product

Nitrofurantoin (monohydrate/macrocrystals)

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Nitrofurantoin (monohydrate/macrocrystals)

42708-178

Regulatory Information

42708-178

ANDA077066

C73584

May 15, 2023

USA

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

QPharma Inc

030620888

Active Ingredients

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

NITROFURANTOIN

Quantity: 25 mg in 1 1

Code: 927AH8112L

Class Code: ACTIB

CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)

Code: Z135WT9208

Class Code: IACT

NITROFURANTOIN MONOHYDRATE

Quantity: 75 mg in 1 1

Code: E1QI2CQQ1I

Class Code: ACTIM

Active Moieties

NITROFURANTOIN

Code: 927AH8112L

© Copyright 2025. All Rights Reserved by MedPath