Home › NDC Lookup › Ingredients › Nitrofurantoin (Monohydrate/Macrocrystal... › 70518-1087-03

Nitrofurantoin (monohydrate/macrocrystals) 75 mg; 25 mg Capsule, 28-count

by REMEDYREPACK INC. · 28 CAPSULE in 1 BOTTLE, PLASTIC (70518-1087-3)

NDC 70518-1087-03

🏷️ FDA NDC (as labeled) 70518-1087-3 billing pads the package segment with a zero

This package

Contains28-count Pack sizes3 compare ↓

Also comes in: 10 capsules 70518-1087-01 30 capsules 70518-1087-02

Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm

🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 70518-1087-3

Product NDC 70518-1087

11-digit billing NDC 70518108703

RxCUI 1648755

UNII E1QI2CQQ1I, 927AH8112L

Application # ANDA077066

SPL Set ID ae892973-9ef4-4cf0-baf3-fbe158697bac

Established class (EPC) Nitrofuran Antibacterial

Chemical class Nitrofurans

DEA schedule Non-controlled

Marketing category ANDA

Marketing status Discontinued

FDA listing status Discontinued by firm

Marketing start 2018-03-29

Route ORAL

Dosage form CAPSULE

Substance NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 70518-1087-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70518-1087-03. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Nitrofuran Antibacterial class.

Pharmacologic class Nitrofuran Antibacterial

Drug family (ATC) Nitrofuran derivatives

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerREMEDYREPACK INC.

Application holderSANDOZ INC

FDA applicationANDA077066 (ANDA)

Labeler code70518

First marketedMar 2018

Product typeHuman Prescription Drug

Portfolio1,499 products on file

🔎 All NDCs from REMEDYREPACK INC.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Nitrofurantoin is used to treat urinary tract infections. Nitrofurantoin is in a class of medications called antibiotics. It works by killing bacteria that cause infection. Antibiotics such as nitrofurantoin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color black / white

ShapeCapsule

ImprintE122

Size21 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII Z135WT9208
Carbomer is a synthetic polymer that forms a thick, gel-like consistency. It's used in medicines as a thickener and stabilizer to improve texture and keep ingredients evenly mixed throughout the product.
UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

13 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 10 capsules 30 capsules

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 00185-0122-01	Sandoz	100 capsules	$0.298	AB	Availability likely	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 00904-7571-61	Major	100 capsules	$0.298	AB	Availability likely	—
Nitrofurantoin 25 mg/1; 75 mg 13811-0719-10	Trigen	100 capsules	$0.298	AB	Availability likely	—
Nitrofurantoin 100 mg 42571-0393-01	Micro	100 capsules	$0.298	AB	Availability likely	—
Nitrofurantoin Monohydrate/ Macrocrystalline 25 mg/1; 75 mg 47781-0303-01	Alvogen	100 capsules	$0.298	AB	Availability likely	—
NITROFURANTOIN (monohydrate/macrocrystals) 75 mg/1; 25 mg 59746-0762-01	Jubilant	100 capsules	$0.298	AB	Availability likely	—
nitrofurantoin (monohydrate/macrocrystals) 25 mg/1; 75 mg 65862-0929-01	Aurobindo	100 capsules	$0.298	—	Availability likely	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 68001-0606-00	BluePoint	100 capsules	$0.298	AB	Availability likely	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 70756-0404-11	Lifestar	100 capsules	$0.298	AB	Availability likely	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 72603-0196-01	NorthStar	100 capsules	$0.298	AB	Availability likely	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 65162-0478-10	Amneal	100 capsules	$0.518	—	FDA listed	—
NITROFURANTOIN (monohydrate/macrocrystals) 75 mg/1; 25 mg 00615-8531-10	NCS	10 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 42708-0178-28	QPharma,	28 capsules	—	AB	FDA listed	—
NITROFURANTOIN (monohydrate/macrocrystals) 75 mg/1; 25 mg 42708-0184-28	QPharma,	28 capsules	—	AB	FDA listed	—
Nitrofurantoin 75 mg/1; 25 mg 50090-6664-00	A-S	14 capsules	—	AB	FDA listed	—
Nitrofurantoin 75 mg/1; 25 mg 50090-6750-01	A-S	10 capsules	—	AB	FDA listed	—
Macrobid 25 mg/1; 75 mg 52427-0285-01	Almatica	100 capsules	—	AB	FDA listed	—
Nitrofurantoin Mono 75 mg/1; 25 mg 54348-0849-06	PharmPak,	6 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 60760-0194-14	St.	14 capsules	—	AB	FDA listed	—
Nitrofurantoin 25 mg/1; 75 mg 60760-0853-14	St.	14 capsules	—	AB	FDA listed	—
Nitrofurantoin Monohydrate Macrocrystalline 25 mg/1; 75 mg 61919-0021-02	Direct_Rx	2 capsules	—	AB	FDA listed	—
Nitrofurantoin Monohydrate/ Macrocrystalline 25 mg/1; 75 mg 63187-0263-10	Proficient	10 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 63187-0995-10	Proficient	10 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 63629-1748-00	Bryant	6 capsules	—	AB	FDA listed	—
Nitrofurantoin 25 mg/1; 75 mg 63629-2464-01	Bryant	100 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 67046-1198-03	Coupler	30 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 67046-1271-03	Coupler	30 capsules	—	AB	FDA listed	—
Nitrofurantoin 25 mg/1; 75 mg 67296-1442-01	Redpharm	10 capsules	—	AB	Discontinued	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 67296-2105-01	Redpharm	14 capsules	—	AB	FDA listed	—
NITROFURANTOIN (monohydrate/macrocrystals) 75 mg/1; 25 mg 67296-2180-01	Redpharm	10 capsules	—	AB	FDA listed	—
Nitrofurantoin 75 mg/1; 25 mg 68071-3569-02	NuCare	20 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 68071-3593-02	NuCare	2 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 68071-4367-02	NuCare	20 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 68071-4428-02	NuCare	2 capsules	—	AB	FDA listed	—
Nitrofurantoin 25 mg/1; 75 mg 68788-8258-00	Preferred	10 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 68788-8571-00	Preferred	10 capsules	—	AB	FDA listed	—
Nitrofurantoin Monohydrate/ Macrocrystalline 25 mg/1; 75 mg 70518-0265-00	REMEDYREPACK	30 capsules	—	AB	Discontinued	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mgthis 70518-1087-03	REMEDYREPACK	28 capsules	—	AB	Discontinued	—
Macrobid 25 mg/1; 75 mg 70518-2531-00	REMEDYREPACK	10 capsules	—	AB	FDA listed	—
Nitrofurantoin 25 mg/1; 75 mg 70518-3717-00	REMEDYREPACK	14 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 70518-4026-00	REMEDYREPACK	10 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 70518-4358-00	REMEDYREPACK	30 capsules	—	AB	FDA listed	—
Nitrofurantoin 25 mg/1; 75 mg 71205-0852-00	Proficient	100 capsules	—	AB	FDA listed	—
Nitrofurantoin 25 mg/1; 75 mg 71335-2255-01	Bryant	40 capsules	—	AB	FDA listed	—
Nitrofurantoin 25 mg/1; 75 mg 71335-2320-00	Bryant	6 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 71335-2377-00	Bryant	6 capsules	—	AB	FDA listed	—
Nitrofurantoin 25 mg/1; 75 mg 71335-2914-01	Bryant	100 capsules	—	AB	FDA listed	—
Nitrofurantoin 25 mg/1; 75 mg 72162-1262-01	Bryant	100 capsules	—	AB	FDA listed	—
Nitrofurantoin 25 mg/1; 75 mg 72162-2615-01	Bryant	100 capsules	—	AB	FDA listed	—
Nitrofurantoin 25 mg/1; 75 mg 72189-0179-10	Directrx	10 capsules	—	AB	FDA listed	—
Nitrofurantoin Monohydrate/Macrocrystal 75 mg/1; 25 mg 72189-0395-14	Direct_Rx	14 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 72789-0234-10	PD-Rx	10 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 72789-0242-06	PD-Rx	6 capsules	—	AB	FDA listed	—
Nitrofurantoin 25 mg/1; 75 mg 72789-0386-06	PD-Rx	6 capsules	—	AB	FDA listed	—
Nitrofurantoin 25 mg/1; 75 mg 72789-0387-10	PD-Rx	10 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 76420-0195-01	Asclemed	100 capsules	—	AB	FDA listed	—
NITROFURANTOIN (monohydrate/macrocrystals) 75 mg/1; 25 mg 76420-0884-00	Asclemed	1000 capsules	—	AB	FDA listed	—
Nitrofurantoin (Monohydrate/Macrocrystals) 25 mg/1; 75 mg 82619-0147-01	Creekwood	100 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 82804-0115-10	Proficient	10 capsules	—	AB	FDA listed	—
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 82868-0012-10	Northwind	10 capsules	—	AB	FDA listed	—
NITROFURANTOIN (monohydrate/macrocrystals) 75 mg/1; 25 mg 82868-0065-10	Northwind	10 capsules	—	AB	FDA listed	—
Nitrofurantoin 75 mg/1; 25 mg 50090-6769-01	A-S	10 capsules	—	AB	Discontinued	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2018

On the market since

Mar 2018

📍

2026

Currently FDA-listed

8 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
70518-1087-02	30 CAPSULE in 1 BLISTER PACK (70518-1087-2)	2021-10-11	Discontinued by firm
70518-1087-03 You're viewing this	28 CAPSULE in 1 BOTTLE, PLASTIC (70518-1087-3)	2022-03-30	Discontinued by firm
70518-1087-01	10 CAPSULE in 1 BOTTLE, PLASTIC (70518-1087-1)	2018-08-16	Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 70518-1087-03?

NDC 70518-1087-03 is a 28-count package — 28 capsule in 1 bottle, plastic.

What is the difference between NDC 70518-1087-03 and NDC 70518-1087-01?

Both are Nitrofurantoin (monohydrate/macrocrystals) 75 mg; 25 mg Capsule — the drug itself is identical. NDC 70518-1087-03 is the 28-count package, while NDC 70518-1087-01 is the 10 capsules package.

What NDC number is used to bill for this package of Nitrofurantoin (monohydrate/macrocrystals) 75 mg; 25 mg Capsule?

Bill NDC 70518-1087-03 — the 11-digit billing format is 70518108703. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

What does the discontinued status mean for this NDC?

The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 70518-1087-3, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70518-1087-03, written without dashes as 70518108703. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 70518-1087-03, the first segment (70518) is the labeler code FDA assigned to REMEDYREPACK INC.; the middle segment (1087) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.

Does this product come in other package sizes?

Yes — the FDA directory lists 2 other package presentations of this same product, including 10 capsules (70518-1087-01), 30 capsules (70518-1087-02). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

REMEDYREPACK INC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Nitrofurantoin (monohydrate/macrocrystals) is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections.

Consequently, many patients who are treated with nitrofurantoin (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria (see CLINICAL STUDIES ). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected.

In considering the use of nitrofurantoin (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.

⏱️ Dosage and Administration 28 words ▾

DOSAGE AND ADMINISTRATION Nitrofurantoin capsules (monohydrate/macrocrystals) should be taken with food. Adults and Pediatric Patients Over 12 Years One 100 mg capsule every 12 hours for seven days.

⛔ Contraindications 129 words ▾

CONTRAINDICATIONS Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications. Treatment of this type of patient carries an increased risk of toxicity because of impaired excretion of the drug. Because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability), the drug is contraindicated in pregnant patients at term (38 to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent.

For the same reason, the drug is contraindicated in neonates under one month of age. Nitrofurantoin (monohydrate/macrocrystals) is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. Nitrofurantoin (monohydrate/macrocrystals) is also contraindicated in those patients with known hypersensitivity to nitrofurantoin.

⚠️ Warnings ~2 min read ▾

WARNINGS Pulmonary Reactions ACUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED WITH NITROFURANTOIN. IF THESE REACTIONS OCCUR, NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) SHOULD BE DISCONTINUED AND APPROPRIATE MEASURES TAKEN. REPORTS HAVE CITED PULMONARY REACTIONS AS A CONTRIBUTING CAUSE OF DEATH.

CHRONIC PULMONARY REACTIONS (DIFFUSE INTERSTITIAL PNEUMONITIS OR PULMONARY FIBROSIS, OR BOTH) CAN DEVELOP INSIDIOUSLY. THESE REACTIONS OCCUR RARELY AND GENERALLY IN PATIENTS RECEIVING THERAPY FOR SIX MONTHS OR LONGER. CLOSE MONITORING OF THE PULMONARY CONDITION OF PATIENTS RECEIVING LONG-TERM THERAPY IS WARRANTED AND REQUIRES THAT THE BENEFITS OF THERAPY BE WEIGHED AGAINST POTENTIAL RISKS (SEE RESPIRATORY REACTIONS).

Hepatotoxicity Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, occur rarely. Fatalities have been reported. The onset of chronic active hepatitis may be insidious, and patients should be monitored periodically for changes in biochemical tests that would indicate liver injury.

If hepatitis occurs, the drug should be withdrawn immediately and appropriate measures should be taken. Neuropathy Peripheral neuropathy, which may become severe or irreversible, has occurred. Fatalities have been reported.

Conditions such as renal impairment (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine), anemia, diabetes mellitus, electrolyte imbalance, vitamin B deficiency, and debilitating disease may enhance the occurrence of peripheral neuropathy. Patients receiving long-term therapy should be monitored periodically for changes in renal function. Optic neuritis has been reported rarely in postmarketing experience with nitrofurantoin formulations.

Hemolytic Anemia Cases of hemolytic anemia of the primaquine-sensitivity type have been induced by nitrofurantoin. Hemolysis appears to be linked to a glucose-6-phosphate dehydrogenase deficiency in the red blood cells of the affected patients. This deficiency is found in 10 percent of Blacks and a small percentage of ethnic groups of Mediterranean and Near-Eastern origin.

Hemolysis is an indication for discontinuing nitrofurantoin (monohydrate/macrocrystals); hemolysis ceases when the drug is withdrawn. Clostridium difficile -Associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including nitrofurantoin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile .

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS In clinical trials of nitrofurantoin (monohydrate/macrocrystals), the most frequent clinical adverse events that were reported as possibly or probably drug-related were nausea (8%), headache (6%), and flatulence (1.5%). Additional clinical adverse events reported as possibly or probably drug-related occurred in less than 1% of patients studied and are listed below within each body system in order of decreasing frequency: Gastrointestinal: Diarrhea, dyspepsia, abdominal pain, constipation, emesis Neurologic : Dizziness, drowsiness, amblyopia Respiratory: Acute pulmonary hypersensitivity reaction (see WARNINGS ) Allergic: Pruritus, urticaria Dermatologic: Alopecia Miscellaneous: Fever, chills, malaise The following additional clinical adverse events have been reported with the use of nitrofurantoin: Gastrointestinal: Sialadenitis, pancreatitis.

There have been sporadic reports of pseudomembranous colitis with the use of nitrofurantoin. The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment (see WARNINGS ). Neurologic: Peripheral neuropathy, which may become severe or irreversible, has occurred.

Fatalities have been reported. Conditions such as renal impairment (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine), anemia, diabetes mellitus, electrolyte imbalance, vitamin B deficiency, and debilitating diseases may increase the possibility of peripheral neuropathy (see WARNINGS ). Asthenia, vertigo, and nystagmus also have been reported with the use of nitrofurantoin.

Benign intracranial hypertension (pseudotumor cerebri), confusion, depression, optic neuritis, and psychotic reactions have been reported rarely. Bulging fontanels, as a sign of benign intracranial hypertension in infants, have been reported rarely. Respiratory: CHRONIC, SUBACUTE, OR ACUTE PULMONARY HYPERSENSITIVITY REACTIONS MAY OCCUR WITH THE USE OF NITROFURANTOIN.

CHRONIC PULMONARY REACTIONS GENERALLY OCCUR IN PATIENTS WHO HAVE RECEIVED CONTINUOUS TREATMENT FOR SIX MONTHS OR LONGER. MALAISE, DYSPNEA ON EXERTION, COUGH, AND ALTERED PULMONARY FUNCTION ARE COMMON MANIFESTATIONS WHICH CAN OCCUR INSIDIOUSLY. RADIOLOGIC AND HISTOLOGIC FINDINGS OF DIFFUSE INTERSTITIAL PNEUMONITIS OR FIBROSIS, OR BOTH, ARE ALSO COMMON MANIFESTATIONS OF THE CHRONIC PULMONARY REACTION.

FEVER IS RARELY PROMINENT. THE SEVERITY OF CHRONIC PULMONARY REACTIONS AND THEIR DEGREE OF RESOLUTION APPEAR TO BE RELATED TO THE DURATION OF THERAPY AFTER THE FIRST CLINICAL SIGNS APPEAR. PULMONARY FUNCTION MAY BE IMPAIRED PERMANENTLY, EVEN AFTER CESSATION OF THERAPY.

THE RISK IS GREATER WHEN CHRONIC PULMONARY REACTIONS ARE NOT RECOGNIZED EARLY. In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form. Upon cessation of therapy, recovery may require several months.

If the symptoms are not recognized as being drug-related and nitrofurantoin therapy is not stopped, the symptoms may become more severe. Acute pulmonary reactions are commonly manifested by fever, chills, cough, chest pain, dyspnea, pulmonary infiltration with consolidation or pleural effusion on x-ray, and eosinophilia. Acute reactions usually occur within the first week of treatment and are reversible with cessation of therapy.

Resolution often is dramatic (see WARNINGS ). Changes in EKG (e.g., non-specific ST/T wave changes, bundle branch block) have been reported in association with pulmonary reactions. Cyanosis has been reported rarely.

Hepatic: Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, occur rarely (see WARNINGS ). Allergic: Lupus-like syndrome associated with pulmonary reaction to nitrofurantoin has been reported. Also, angioedema; maculopapular, erythematous, or eczematous eruptions; anaphylaxis; arthralgia; myalgia; drug fever; chills; and vasculitis (sometimes associated with pulmonary reactions) have been reported.

Hypersensitiv…

🔄 Drug Interactions 73 words ▾

Drug Interactions Antacids containing magnesium trisilicate, when administered concomitantly with nitrofurantoin, reduce both the rate and extent of absorption. The mechanism for this interaction probably is adsorption of nitrofurantoin onto the surface of magnesium trisilicate. Uricosuric drugs, such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion of nitrofurantoin.

The resulting increase in nitrofurantoin serum levels may increase toxicity, and the decreased urinary levels could lessen its efficacy as a urinary tract antibacterial.

🤰 Pregnancy 194 words ▾

Pregnancy Teratogenic Effects Several reproduction studies have been performed in rabbits and rats at doses up to six times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to nitrofurantoin. In a single published study conducted in mice at 68 times the human dose (based on mg/kg administered to the dam), growth retardation and a low incidence of minor and common malformations were observed. However, at 25 times the human dose, fetal malformations were not observed; the relevance of these findings to humans is uncertain.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Non-Teratogenic Effects Nitrofurantoin has been shown in one published transplacental carcinogenicity study to induce lung papillary adenomas in the F1 generation mice at doses 19 times the human dose on a mg/kg basis.

The relationship of this finding to potential human carcinogenesis is presently unknown. Because of the uncertainty regarding the human implications of these animal data, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 33 words ▾

Pediatric Use Nitrofurantoin (monohydrate/macrocrystals) is contraindicated in infants below the age of one month (see CONTRAINDICATIONS ). Safety and effectiveness in pediatric patients below the age of twelve years have not been established.

🧓 Geriatric Use 219 words ▾

Geriatric Use Clinical studies of nitrofurantoin (monohydrate/macrocrystals) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Spontaneous reports suggest a higher proportion of pulmonary reactions, including fatalities, in elderly patients; these differences appear to be related to the higher proportion of elderly patients receiving long-term nitrofurantoin therapy.

As in younger patients, chronic pulmonary reactions generally are observed in patients receiving therapy for six months or longer (see WARNINGS ). Spontaneous reports also suggest an increased proportion of severe hepatic reactions, including fatalities, in elderly patients (see WARNINGS ). In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing nitrofurantoin (monohydrate/macrocrystals).

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications (see CONTRAINDICATIONS ). Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.

🆘 Overdosage 46 words ▾

OVERDOSAGE Occasional incidents of acute overdosage of nitrofurantoin have not resulted in any specific symptoms other than vomiting. Induction of emesis is recommended. There is no specific antidote, but a high fluid intake should be maintained to promote urinary excretion of the drug. Nitrofurantoin is dialyzable.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Each nitrofurantoin capsule (monohydrate/macrocrystals) contains two forms of nitrofurantoin. Twenty-five percent is macrocrystalline nitrofurantoin, which has slower dissolution and absorption than nitrofurantoin monohydrate. The remaining 75% is nitrofurantoin monohydrate contained in a powder blend which, upon exposure to gastric and intestinal fluids, forms a gel matrix that releases nitrofurantoin over time.

Based on urinary pharmacokinetic data, the extent and rate of urinary excretion of nitrofurantoin from the 100 mg nitrofurantoin capsules (monohydrate/macrocrystals) are similar to those of 50 mg or 100 mg nitrofurantoin (macrocrystals) capsules. Approximately 20% to 25% of a single dose of nitrofurantoin is recovered from the urine unchanged over 24 hours. Plasma nitrofurantoin concentrations after a single oral dose of the 100 mg nitrofurantoin capsules (monohydrate/macrocrystals) are low, with peak levels usually less than 1 mcg/mL.

Nitrofurantoin is highly soluble in urine, to which it may impart a brown color. When nitrofurantoin (monohydrate/macrocrystals) is administered with food, the bioavailability of nitrofurantoin is increased by approximately 40%. Microbiology Nitrofurantoin is a nitrofuran antimicrobial agent with activity against certain Gram-positive and Gram-negative bacteria.

Mechanism of Action The mechanism of the antimicrobial action of nitrofurantoin is unusual among antibacterials. Nitrofurantoin is reduced by bacterial flavoproteins to reactive intermediates which inactivate or alter bacterial ribosomal proteins and other macromolecules. As a result of such inactivations, the vital biochemical processes of protein synthesis, aerobic energy metabolism, DNA synthesis, RNA synthesis, and cell wall synthesis are inhibited.

Nitrofurantoin is bactericidal in urine at therapeutic doses. The broad-based nature of this mode of action may explain the lack of acquired bacterial resistance to nitrofurantoin, as the necessary multiple and simultaneous mutations of the target macromolecules would likely be lethal to the bacteria. Interactions with Other Antibiotics Antagonism has been demonstrated in vitro between nitrofurantoin and quinolone antimicrobials.

The clinical significance of this finding is unknown. Development of Resistance Development of resistance to nitrofurantoin has not been a significant problem since its introduction in 1953. Cross-resistance with antibiotics and sulfonamides has not been observed, and transferable resistance is, at most, a very rare phenomenon.

Nitrofurantoin has been shown to be active against most strains of the following bacteria both in vitro and in clinical infections: (see INDICATIONS AND USAGE ). Aerobic and Facultative Gram-Positive Microorganisms Staphylococcus saprophyticus Aerobic and Facultative Gram-Negative Microorganisms Escherichia coli At least 90 percent of the following microorganisms exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for nitrofurantoin. However, the efficacy of nitrofurantoin in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled trials.

Aerobic and Facultative Gram-Positive Microorganisms Coagulase-negative staphylococci (including Staphylococcus epidermidis ) Enterococcus faecalis Staphylococcus aureus Streptococcus agalactiae Group D streptococci Viridans group streptococci Aerobic and Facultative Gram-Negative Microorganisms Citrobacter amalonaticus Citrobacter diversus Citrobacter freundii Klebsiella oxytoca Klebsiella ozaenae Nitrofurantoin is not active against most strains of Proteus species or Serratia species. It has no activity against Pseudomonas species.

Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

📦 How Supplied / Storage and Handling 113 words ▾

HOW SUPPLIED Nitrofurantoin capsules, USP (monohydrate/macrocrystals), for oral administration, are available as: 100 mg: Black and ivory opaque capsules imprinted “E 122” on the cap and body and supplied as: NDC: 70518-1087-00 NDC: 70518-1087-01 NDC: 70518-1087-02 NDC: 70518-1087-03 PACKAGING: 14 in 1 BOTTLE PLASTIC PACKAGING: 10 in 1 BOTTLE PLASTIC PACKAGING: 30 in BLISTER PACK PACKAGING: 28 in BOTTLE PLASTIC Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.

KEEP OUT OF THE REACH OF CHILDREN. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr.

Suite #4 Indiana, PA 1-724-465-8762

📋 Description 132 words ▾

DESCRIPTION Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are hard gelatin capsule shells containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals USP and 75 mg of nitrofurantoin monohydrate USP. The chemical name of nitrofurantoin macrocrystals USP is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione.

The chemical structure is the following: Molecular Weight: 238.16 The chemical name of nitrofurantoin monohydrate USP is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione monohydrate. The chemical structure is the following: Molecular Weight: 256.17 Inactive Ingredients Each capsule contains carbomer 934P, colloidal silicon dioxide, corn starch, compressible sugar, D&C yellow No. 10, edible white ink, FD&C blue No.

1, FD&C red No. 40, gelatin, lactose monohydrate, magnesium stearate, povidone, talc, and titanium dioxide. Meets USP Dissolution Test 5 Chemical Structure 1 Chemical Structure 2

💬 Information for Patients ~1 min read ▾

Information for Patients Patients should be advised to take nitrofurantoin (monohydrate/macrocrystals) with food (ideally breakfast and dinner) to further enhance tolerance and improve drug absorption. Patients should be instructed to complete the full course of therapy; however, they should be advised to contact their physician if any unusual symptoms occur during therapy. Patients should be advised not to use antacid preparations containing magnesium trisilicate while taking nitrofurantoin (monohydrate/macrocrystals) .

Patients should be counseled that antibacterial drugs including nitrofurantoin (monohydrate/macrocrystals) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When nitrofurantoin (monohydrate/macrocrystals) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by nitrofurantoin (monohydrate/macrocrystals) or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic.

If this occurs, patients should contact their physician as soon as possible. Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

lupus-like syndrome: A set of symptoms resembling lupus, such as joint pain, rash, and fever, that appears while taking a substance and usually settles after stopping it.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

alopecia: Loss of hair from the scalp or body.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

antimicrobial resistance: When germs change over time so that the medicines meant to kill them no longer work well.

anuria: Producing little or no urine, which can be a sign of severe kidney problems.

arthralgia: Joint pain.

asthenia: Unusual weakness or lack of physical strength and energy.

bactericidal: Describes a medicine that kills bacteria outright.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

cyanosis: A bluish color of the skin, lips, or nails caused by too little oxygen in the blood.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

fertility: The natural ability to become pregnant or to father a child.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

hemolysis: The breaking apart of red blood cells, which can lower the number of cells available to carry oxygen.

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myalgia: Muscle pain or aching.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

nystagmus: Rapid, involuntary back-and-forth movements of the eyes that a person cannot control.

oliguria: Producing much less urine than normal, which is often a sign the kidneys are under stress.

optic neuritis: Swelling and irritation of the nerve that carries signals from the eye to the brain, which can affect vision.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

peripheral neuropathy: Damage to the nerves outside the brain and spinal cord, often causing numbness, tingling, or pain in the hands and feet.

pleural effusion: A buildup of fluid in the space between the lungs and the chest wall.

pneumonitis: Inflammation of the lung tissue that is not caused by an infection and can lead to cough and breathlessness.

pruritus: Itching of the skin.

pseudomembranous colitis: A serious swelling of the large intestine, usually caused by C. difficile bacteria, that leads to severe diarrhea.

pulmonary fibrosis: Scarring and thickening of lung tissue that makes the lungs stiff and breathing harder over time.

refractory: Describing a disease that does not respond to, or improve with, treatment.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

serum creatinine: A waste product measured in a blood test; higher levels can mean the kidneys are not filtering as well as normal.

susceptibility testing: A lab test that grows germs from a sample and checks which medicines can stop or kill them.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

tolerance: When the body gets used to a medicine over time, so a larger dose is needed to get the same effect.

urticaria: Raised, itchy welts on the skin, commonly called hives.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 70518-1082-01 · REMEDYREPACK 70518-1094-00 · REMEDYREPACK →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Nitrofurantoin (monohydrate/macrocrystals) 75 mg; 25 mg Capsule, 28-count

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

📦 Packaging — all sizes for this product

Pack size FAQ

🧭 About this NDC listing & data coverage

Questions about this listing

📄 Full prescribing information FDA SPL

🔗 Related NDC lookups