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Nitrofurantoin 25 mg; 75 mg Capsule, 28-count

by Preferred Pharmaceuticals Inc. · 28 CAPSULE in 1 BOTTLE (68788-8258-8)
NDC 68788-8258-08
🏷️ FDA NDC (as labeled) 68788-8258-8 billing pads the package segment with a zero
This package
Contains28-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.6443/unit — full pricing hub ↓
Also comes in: 10 capsules 68788-8258-00 14 capsules 68788-8258-01
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 20, 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

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

🆔 Identity & classification

FDA NDC (as labeled) 68788-8258-8
Product NDC 68788-8258
11-digit billing NDC 68788825808
RxCUI 1648755
UNII 927AH8112L, E1QI2CQQ1I
Application # ANDA208516
SPL Set ID 729f6bbb-ab64-4b65-979a-4ad7605c5947
Established class (EPC) Nitrofuran Antibacterial
Chemical class Nitrofurans
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-09-16
Route ORAL
Dosage form CAPSULE
Substance NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 68788-8258-8 — 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 → 68788-8258-08. 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

LabelerPreferred Pharmaceuticals Inc.
Application holderSUNNY PHARMTECH INC
FDA applicationANDA208516 (ANDA)
Labeler code68788
First marketedSep 2022
Product typeHuman Prescription Drug
Portfolio825 products on file
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

📗 Our plain-language guide HelloPharmacist
  • Yes, nitrofurantoin is used specifically for urinary tract infections — typically bladder infections caused by certain bacteria. It's not used for kidney infections or for infectio...
  • What exactly is nitrofurantoin used for — is it just for bladder infections?
  • Taking it with food genuinely makes a difference — it helps your body absorb the medication better and also reduces the chances of an upset stomach or nausea, which are the most co...
  • Do I really have to take it with food? What if I forget?
📖 Read our full Nitrofurantoin guide →
7
Nutrient depletion considerations

Nitrofurantoin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Nitrofurantoin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 yellow
ShapeCapsule
Imprint101
Size22 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 systemPer eachPer 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 · Q2 2026 $0.6443 $18.04 / 28 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

ProductLabelerPackNADAC/unitTEStatusPrice 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 mgthis 68788-8258-08 Preferred 28 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 mg 70518-1087-02 REMEDYREPACK 30 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 25 mg/1; 75 mg 68071-2928-04 NuCare 14 capsules — AB FDA listed —
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

🏛️
2022
On the market since
Sep 2022
📍
2026
Currently FDA-listed
4 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Nitrofurantoin — the program that covers self-administered drugs. 6 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Nitrofurantoin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$4.68M
Claims incl. refills
993
Beneficiaries
668
Spend / beneficiary
$7,003.05
Spend / claim
$4,711.01
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for NITROFURANTOIN — the ingredient across all brands.

Top reported reactions

Urinary Tract Infection2,221
Fatigue1,839
Nausea1,827
Headache1,705
Pain1,501
Dyspnoea1,437
Diarrhoea1,285

Age at onset

Neonate59
Infant20
Child23
Adolescent22
Adult1,778
Elderly1,528

Reporter sex

22,743 reports
Male · 14%
Female · 85%
Unknown · 0%

Serious outcomes

Hospitalization7,727
Death1,406
Disabling1,063
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,997 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68788-8258-00 10 CAPSULE in 1 BOTTLE (68788-8258-0) 2022-09-16 Active
68788-8258-01 14 CAPSULE in 1 BOTTLE (68788-8258-1) 2022-09-16 Active
68788-8258-08 You're viewing this 28 CAPSULE in 1 BOTTLE (68788-8258-8) 2023-08-15 Active

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

Pack size FAQ

What quantity is in NDC 68788-8258-08?
NDC 68788-8258-08 is a 28-count package — 28 capsule in 1 bottle.
What is the difference between NDC 68788-8258-08 and NDC 68788-8258-00?
Both are Nitrofurantoin 25 mg; 75 mg Capsule — the drug itself is identical. NDC 68788-8258-08 is the 28-count package, while NDC 68788-8258-00 is the 10 capsules package.
What NDC number is used to bill for this package of Nitrofurantoin 25 mg; 75 mg Capsule?
Bill NDC 68788-8258-08 — the 11-digit billing format is 68788825808. 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
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
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 68788-8258-8, 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: 68788-8258-08, written without dashes as 68788825808. 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 68788-8258-08, the first segment (68788) is the labeler code FDA assigned to Preferred Pharmaceuticals Inc.; the middle segment (8258) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Preferred Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 10 capsules (68788-8258-00), 14 capsules (68788-8258-01). 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?
Preferred Pharmaceuticals 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 Capsules, USP (monohydrate/macrocrystals) are 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 Capsules, USP (monohydrate/macrocrystals) and other antibacterial drugs, Nitrofurantoin Capsules, USP (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 Capsules, USP (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria. (see Error! Hyperlink reference not valid. ).

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 Capsules, USP (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Capsules, USP (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 29 words ▾

DOSAGE AND ADMINISTRATION: Nitrofurantoin Capsules, USP (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 133 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 Capsules, USP (monohydrate/macrocrystals) is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. Nitrofurantoin Capsules, USP (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 CAPSULES, USP (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 Capsules, USP (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 Capsules, USP (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 Error!

Hyperlink reference not valid. ) 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 Error!

Hyperlink reference not valid. ). 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 Error! Hyperlink reference not valid. ). 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 Error! Hyperlink reference not valid. ). 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 Error! Hyperlink reference not valid. ).

Allergic: Lupus-like syndrome associated with pulmonary reaction to nitrofurantoin has been reported. Also, angioedema; maculopapular, erythematous, or eczematous e…

🔄 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 197 words ▾

Pregnancy: Teratogenic effects: Pregnancy Category B. 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 39 words ▾

Pediatric Use: Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) is contraindicated in infants below the age of one month (see Error! Hyperlink reference not valid. ). Safety and effectiveness in pediatric patients below the age of twelve years have not been established.

🧓 Geriatric Use ~1 min read ▾

Geriatric Use: Clinical studies of Nitrofurantoin Capsules, USP (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 Error! Hyperlink reference not valid. ). Spontaneous reports also suggest an increased proportion of severe hepatic reactions, including fatalities, in elderly patients (see Error!

Hyperlink reference not valid. ). 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 Capsules, USP (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 Error! Hyperlink reference not valid. ). 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 Capsules, USP (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, USP (monohydrate/ macrocrystals) are similar to those of the 50 mg or 100 mg nitrofurantoin (macrocrystals) capsule. 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, USP (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 Capsules, USP (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 Error!

Hyperlink reference not valid. ]. 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 Test Methods: For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by…

📦 How Supplied / Storage and Handling 58 words ▾

HOW SUPPLIED: Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) is available as 100 mg opaque yellowish brown and pale yellow capsules imprinted “101” on both cap and body. NDC 68788-8258-0 bottle of 10 NDC 68788-8258-1 bottle of 14 NDC 68788-8258-8 bottle of 28 Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature.] Rx Only

📋 Description 154 words ▾

DESCRIPTION: Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin Capsules , USP (monohydrate/macrocrystals) is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals 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 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 974P, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Blue No.1, FD&C Red No.40, FD&C Yellow No.

6, gelatin, lactose, magnesium stearate, Opacode ® black ink S-1-17843 (consist of shellac, ferrosoferric oxide, butyl alcohol, propylene glycol, isopropyl alcohol and ammonia), povidone, pregelatinized starch, sodium lauryl sulfate, sucrose, talc, titanium dioxide. FDA approved dissolution test specifications differ from USP. nitrofurantoin macrocrystals nitrofurantoin monohydrate

💬 Information for Patients ~1 min read ▾

Information for Patients: Patients should be advised to take Nitrofurantoin Capsules, USP (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 Capsules, USP (monohydrate/macrocrystals).

Patients should be counseled that antibacterial drugs including Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Nitrofurantoin Capsules, USP (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 Capsules, USP (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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68788-8257-01 · Preferred 68788-8261-02 · Preferred →
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.