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Nitrofurantoin (monohydrate/macrocrystals) 75 mg; 25 mg Capsule, 100-count — NDC 72603-0196-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nitrofurantoin (monohydrate/macrocrystals) 75 mg; 25 mg Capsule, 100-count — NDC 72603-196-01 (Billing 72603-0196-01)

by NorthStar RxLLC · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of Nitrofurantoin (monohydrate/macrocrystals) 75 mg; 25 mg Capsule from NorthStar RxLLC, marketed since Dec 2023 and currently FDA-listed; retail pharmacies pay about $0.2958 per capsule (NADAC). It is this product's only package size.

NDC 72603-0196-01
🏷️ FDA NDC (as labeled) 72603-196-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72603-196-01
Product NDC 72603-196
11-digit billing NDC 72603019601
NCPDP billing unit EA — each (per item)
RxCUI 1648755
UNII E1QI2CQQ1I, 927AH8112L
UPC 0372603196016
Application # ANDA217357
SPL Set ID d1c778b5-70df-4312-976b-d0bca0cb602a
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 2023-12-01
Route ORAL
Dosage form CAPSULE
Substance NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 16800050150120
GCN Seq No 016598
GCN 49001
HICL code 006322
Ingredient (HICL) Nitrofurantoin Monohyd/M-Cryst
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W2
Therapeutic class — intermediate (HIC2) Antibacterials
HIC3 code W2F
Therapeutic class — specific (HIC3) Nitrofuran Derivatives Antibacterial Agents
AHFS code 08:36.00.00
AHFS class Urinary Anti-Infectives
FDB label name NITROFURANTOIN MONO-MCR 100 MG
FDB brand name Nitrofurantoin Mono-Macro
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 016598
  • GCN: 49001
  • GPI-14 (Medi-Span): 16800050150120
  • HICL (First Databank): 006322
  • AHFS class code: 08:36.00.00
  • RxCUI (RxNorm): 1648755
Why two NDCs? The FDA registers this code as 72603-196-01 — a 5-3-2 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 product segment → 72603-0196-01. 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.

Clinical

Label name NITROFURANTOIN MONO-MCR 100 MG Ingredient Nitrofurantoin Monohyd/M-Cryst
📖 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 ↗

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.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.296 $29.58 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $0.8788 $87.88 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $0.6443 $64.43 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.352 $0.296
▼ Down 16% over the last 10 months.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72603-0196-01 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE 2023-12-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 00185-0122-01 Sandoz 100 capsules $0.296 AB Availability likely —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 00904-7571-61 Major 100 capsules $0.296 AB Availability likely —
Nitrofurantoin 25 mg/1; 75 mg 13811-0719-10 Trigen 100 capsules $0.296 AB Availability likely —
Nitrofurantoin 100 mg 42571-0393-01 Micro 100 capsules $0.296 AB Availability likely —
Nitrofurantoin Monohydrate/ Macrocrystalline 25 mg/1; 75 mg 47781-0303-01 Alvogen 100 capsules $0.296 AB Availability likely —
NITROFURANTOIN (monohydrate/macrocrystals) 75 mg/1; 25 mg 59746-0762-01 Jubilant 100 capsules $0.296 AB Availability likely —
nitrofurantoin (monohydrate/macrocrystals) 25 mg/1; 75 mg 65862-0929-01 Aurobindo 100 capsules $0.296 — Availability likely —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 68001-0606-00 BluePoint 100 capsules $0.296 AB Availability likely —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 70756-0404-11 Lifestar 100 capsules $0.296 AB Availability likely —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mgthis 72603-0196-01 NorthStar 100 capsules $0.296 AB Availability likely —
Nitrofurantoin (monohydrate/macrocrystals) 75 mg/1; 25 mg 65162-0478-10 Amneal 100 capsules $0.518 — FDA listed +75%
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 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 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

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 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.

What it looks like

Color Gray / Brown
ShapeCapsule
Imprintlifestar;404
Size19 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 HHT01ZNK31
    Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
  • 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 PN2ZH5LOQY
    A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for 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 WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII RDH86HJV5Z
    Povidone K90 is a synthetic polymer made from a chemical called vinyl pyrrolidone. It acts as a binder to hold pill ingredients together and as a dispersant to help the medicine break down and dissolve properly in your body.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • 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.

16 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.

Manufacturer & labeler

LabelerNorthStar RxLLC
Application holderMANKIND PHARMA LTD
FDA applicationANDA217357 (ANDA)
Labeler code72603
First marketedDec 2023
Product typeHuman Prescription Drug
Portfolio308 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🔬 Clinical Studies 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Nitrofurantoin capsules (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 (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (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 (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 capsules (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected.

In considering the use of nitrofurantoin capsules (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 (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 131 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 (monohydrate/macrocrystals) are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. Nitrofurantoin capsules (monohydrate/macrocrystals) are 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 (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 (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 (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.… [Excerpted — this section continues on DailyMed.]

🆘 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 162 words ▾

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 capsule (monohydrate/macrocrystals) is similar to those of 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 (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 capsule (monohydrate/macrocrystals) is administered with food, the bioavailability of nitrofurantoin is increased by approximately 40%.

📦 How Supplied / Storage and Handling 83 words ▾

HOW SUPPLIED Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are available as 100 mg grey opaque cap and brown opaque body, hard gelatin, size "1" capsules imprinted with logo on cap and "404" on body with white ink, containing light yellow to yellow color powder and one oval uncoated tablet plain on both sides. NDC 72603-196-01 bottles of 100 capsules with child-resistant closure Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Image

📋 Description 161 words ▾

DESCRIPTION Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsule, USP (monohydrate/macrocrystals) is a hard gelatin capsule. Each capsule contains 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 2,4-Imidazolidinedione, 1-[[(5-nitro-2-furanyl)methylene]-amino]. The chemical structure is the following: Molecular Weight: 238.16 Molecular formula: C 8 H 6 N 4 O 5 The chemical name of nitrofurantoin monohydrate, USP is 2,4-Imidazolidinedione, 1-[[(5-nitro-2-furanyl)methylene]-amino]-monohydrate. The chemical structure is the following: Molecular Weight: 256.18 Molecular formula: C 8 H 6 N 4 O 5 · H 2 O Inactive Ingredients: Each capsule contains carbomer homopolymer type B, corn starch, D&C Yellow No.

10, FD&C Blue No.1, FD&C Red No. 40, FD&C Red No. 3, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, povidone K 30, povidone K 90, shellac, sucrose, talc, and titanium dioxide.

FDA approved dissolution test specifications differ from USP structure1 structure2

⚠️ Precautions ~3 min read ▾

PRECAUTIONS Information for Patients: Patients should be advised to take nitrofurantoin capsules (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 (monohydrate/macrocrystals).

Patients should be counseled that antibacterial drugs including nitrofurantoin capsules (monohydrate/macrocrystals) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When nitrofurantoin capsules (monohydrate/macrocrystals) are 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 (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. General: Prescribing nitrofurantoin capsules (monohydrate/macrocrystals) in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. 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.

Drug/Laboratory Test Interactions: As a result of the presence of nitrofurantoin, a false-positive reaction for glucose in the urine may occur. This has been observed with Benedict's and Fehling's solutions but not with the glucose enzymatic test. Carcinogenesis, Mutagenesis, Impairment of Fertility: Nitrofurantoin was not carcinogenic when fed to female Holtzman rats for 44.5 weeks or to female Sprague-Dawley rats for 75 weeks.

Two chronic rodent bioassays utilizing male and female Sprague-Dawley rats and two chronic bioassays in Swiss mice and in BDF1 mice revealed no evidence of carcinogenicity. Nitrofurantoin presented evidence of carcinogenic activity in female B6C3F1 mice as shown by increased incidences of tubular adenomas, benign mixed tumors, and granulosa cell tumors of the ovary. In male F344/N rats, there were increased incidences of uncommon kidney tubular cell neoplasms, osteosarcomas of the bone, and neoplasms of the subcutaneous tissue.

In one study involving subcutaneous administration of 75 mg/kg nitrofurantoin to pregnant female mice, lung papillary adenomas of unknown significance were observed in the F1 generation. Nitrofurantoin has been shown to induce point mutations in certain strains of Salmonella typhimurium and forward mutations in L5178Y mouse lymphoma cells. Nitrofurantoin induced increased numbers of sister chromatid exchanges an… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies 75 words ▾

CLINICAL STUDIES Controlled clinical trials comparing nitrofurantoin capsules (monohydrate/macrocrystals) 100 mg p.o. q12h and Macrodantin 50 mg p.o. q6h in the treatment of acute uncomplicated urinary tract infections demonstrated approximately 75% microbiologic eradication of susceptible pathogens in each treatment group. Brands listed are trademark of their respective owners. Manufactured for: Northstar Rx LLC Memphis, TN 38141.

Toll Free: 1-800-206-7821 Manufactured by: Mankind Pharma Limited Paonta Sahib, Sirmaur Himachal Pradesh 173025, India. Issued: August 2023, V-01

📄 Package Label / Principal Display Panel 22 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 72603- 196 -01 Rx only Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg URINARY TRACT ANTIBACTERIAL 100 Capsules 100slabel

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
103.5K
Units reimbursed last 4 qtrs
1.4M
Gross reimbursed last 4 qtrs
$1.19M
Avg / prescription
$11.50
Avg / unit
$0.8788
Latest quarter Q1 2026
21.9KRx
Medicaid pays / ea
$0.8788
gross reimbursed
vs
NADAC / ea
$0.2958
acquisition cost
=
Spread
+$0.5830
+197% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
39% FFS 61% MCO
Fee-for-service · 39,938 Rx Managed care · 63,548 Rx
State Medicaid map
Alaska: 9,963 units · 1,359 per 100k residents AK Maine: 4,786 units · 343 per 100k residents ME Washington: 113,960 units · 1,459 per 100k residents WA Idaho: 17,003 units · 866 per 100k residents ID Montana: 14,321 units · 1,265 per 100k residents MT North Dakota: 7,577 units · 968 per 100k residents ND Minnesota: 24,286 units · 423 per 100k residents MN Wisconsin: 12,965 units · 219 per 100k residents WI Michigan: 19,201 units · 191 per 100k residents MI New York: 86,207 units · 440 per 100k residents NY Vermont: 11,290 units · 1,745 per 100k residents VT New Hampshire: 2,753 units · 196 per 100k residents NH Oregon: 76,641 units · 1,811 per 100k residents OR Nevada: 13,981 units · 438 per 100k residents NV Wyoming: 2,735 units · 468 per 100k residents WY South Dakota: 1,889 units · 206 per 100k residents SD Iowa: 7,645 units · 238 per 100k residents IA Illinois: 45,322 units · 361 per 100k residents IL Indiana: 15,315 units · 223 per 100k residents IN Ohio: 32,478 units · 276 per 100k residents OH Pennsylvania: 12,924 units · 99.7 per 100k residents PA New Jersey: 11,506 units · 124 per 100k residents NJ Massachusetts: 6,798 units · 97.1 per 100k residents MA California: 146,909 units · 377 per 100k residents CA Utah: 2,057 units · 60.2 per 100k residents UT Colorado: 35,808 units · 609 per 100k residents CO Nebraska: 9,900 units · 501 per 100k residents NE Missouri: 30,264 units · 488 per 100k residents MO Kentucky: 49,902 units · 1,103 per 100k residents KY West Virginia: 11,120 units · 628 per 100k residents WV Virginia: 10,095 units · 116 per 100k residents VA Maryland: 16,136 units · 261 per 100k residents MD Connecticut: 4,703 units · 130 per 100k residents CT Rhode Island: 1,237 units · 113 per 100k residents RI Arizona: 38,191 units · 514 per 100k residents AZ New Mexico: 17,693 units · 837 per 100k residents NM Kansas: 2,792 units · 95.0 per 100k residents KS Arkansas: 14,349 units · 468 per 100k residents AR Tennessee: 20,591 units · 289 per 100k residents TN North Carolina: 20,789 units · 192 per 100k residents NC South Carolina: 8,813 units · 164 per 100k residents SC Delaware: 1,992 units · 193 per 100k residents DE Oklahoma: 20,949 units · 517 per 100k residents OK Louisiana: 31,749 units · 694 per 100k residents LA Mississippi: 17,892 units · 609 per 100k residents MS Alabama: 40,009 units · 783 per 100k residents AL Georgia: 18,078 units · 164 per 100k residents GA D.C.: 3,122 units · 460 per 100k residents DC Hawaii: 3,805 units · 265 per 100k residents HI Texas: 215,639 units · 707 per 100k residents TX Florida: 8,199 units · 36.3 per 100k residents FL
Units reimbursed · per 100k residents
36.31,811
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Oregon 1,811 /100k
2 Vermont 1,745 /100k
3 Washington 1,459 /100k
4 Alaska 1,359 /100k
5 Montana 1,265 /100k
6 Kentucky 1,103 /100k
7 North Dakota 968 /100k
8 Idaho 866 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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 (monohydrate/macrocrystals) — the ingredient across all brands.

Top reported reactions

Urinary Tract Infection1,375
Fatigue1,281
Nausea1,244
Headache1,156
Dyspnoea1,013
Pain1,001
Diarrhoea916

Age at onset

Neonate51
Infant16
Child21
Adolescent18
Adult1,368
Elderly1,177

Reporter sex

16,612 reports
Male · 16%
Female · 84%
Unknown · 0%

Serious outcomes

Hospitalization5,709
Death1,041
Life-threatening873
Disabling850
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,522 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.
← 72603-0195-10 · NorthStar 72603-0198-01 · NORTHSTAR →
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.