NDC 68382-0559-30 — nitrofurantoin macrocrystals 50 mg, 100-count

🆔 Identity & classification

FDA NDC (as labeled) 68382-559-30

Product NDC 68382-559

11-digit billing NDC 68382055930

RxCUI 311995, 1648759

UNII 927AH8112L

Application # ANDA205005

SPL Set ID 2862e49a-66e9-4418-9343-4404036775fc

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 2018-02-15

Route ORAL

Dosage form CAPSULE

Substance NITROFURANTOIN

GPI-14 16800050100115

GPI class Nitrofurantoin Macrocrystal

GCN Seq No 009430

GCN 41822

HICL code 004087

Ingredient (HICL) Nitrofurantoin Macrocrystal

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 MCR 50 MG CAP

FDB brand name Nitrofurantoin

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 68382-559-30 — 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 → 68382-0559-30. 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

LabelerZydus Pharmaceuticals (USA) Inc.

Application holderZYDUS PHARMACEUTICALS USA INC

FDA applicationANDA205005 (ANDA)

Labeler code68382

First marketedFeb 2018

Product typeHuman Prescription Drug

Portfolio173 products on file

🔎 All NDCs from Zydus Pharmaceuticals (USA) 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

Label name NITROFURANTOIN MCR 50 MG CAP Ingredient Nitrofurantoin Macrocrystal

📗 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 →

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 Blue / White

ShapeCapsule

Imprint560

Size18 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 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 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 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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 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.

9 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 · Q2 2026	$0.3581	$35.81 / 100 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 macrocrystals 50 mg 43386-0641-01	Lupin	100 capsules	$0.153	AB	Availability likely	—
Nitrofurantoin Macrocrystals 50 mg 00115-1643-01	Amneal	100 capsules	$0.159	AB	Availability likely	—
nitrofurantoin macrocrystals 50 mg 00904-7026-61	Major	100 capsules	$0.159	AB	Availability likely	—
Nitrofurantoin Macrocrystals 50 mg 50268-0623-15	AvPAK	50 capsules	$0.159	AB	Availability likely	—
nitrofurantoin (macrocrystals) 50 mg 59651-0753-01	Aurobindo	100 capsules	$0.159	AB	Availability likely	—
Nitrofurantoin Macrocrystals 50 mg 60687-0839-01	American	100 capsules	$0.159	AB	Availability likely	—
Nitrofurantoin 50 mg 62332-0390-31	Alembic	100 capsules	$0.159	AB	Availability likely	—
nitrofurantoin macrocrystals 50 mg 68001-0604-00	BluePoint	100 capsules	$0.159	AB	Availability likely	—
nitrofurantoin macrocrystals 50 mg 70756-0411-11	Lifestar	100 capsules	$0.159	AB	Availability likely	—
nitrofurantoin macrocrystals 50 mg 72603-0183-01	NorthStar	100 capsules	$0.159	AB	Availability likely	—
nitrofurantoin macrocrystals 50 mg 47781-0307-01	Alvogen	100 capsules	$0.310	AB	Discontinued	—
Nitrofurantion 50 mg 68001-0385-00	BluePoint	100 capsules	$0.310	—	FDA listed	—
Nitrofurantoin 50 mg 46708-0390-31	Alembic	100 capsules	—	AB	FDA listed	—
Macrodantin 50 mg 52427-0287-01	Almatica	100 capsules	—	AB	Discontinued	—
Nitrofurantion 50 mg 57664-0232-18	Sun	1000 capsules	—	—	FDA listed	—
nitrofurantoin macrocrystals 50 mgthis 68382-0559-30	Zydus	100 capsules	—	AB	FDA listed	—
nitrofurantoin macrocrystals 50 mg 70771-1170-00	Zydus	1000 capsules	—	AB	FDA listed	—
Nitrofurantion Macrocrystals 50 mg 71205-0023-10	Proficient	10 capsules	—	AB	FDA listed	—
nitrofurantoin macrocrystals 50 mg 71335-2254-01	Bryant	28 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

🏛️

2018

On the market since

Feb 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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

100 capsules68382-0559-01 6,731 Rx · $99,347

1000 capsules68382-0559-10 No Medicaid data

10 capsules this page68382-0559-30 No Medicaid data

Drug total (last 4 qtrs): 6,731 Rx · 202,360 units · $99,347 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
68382-0559-01	100 CAPSULE in 1 BOTTLE (68382-559-01)	$0.1587 / ea	$15.87	2018-02-15	Active
68382-0559-10	1000 CAPSULE in 1 BOTTLE (68382-559-10)	—	—	2018-02-15	Active
68382-0559-30 You're viewing this	10 BLISTER PACK in 1 CARTON (68382-559-30) / 10 CAPSULE in 1 BLISTER PACK	—	—	2018-02-15	Active

This pack shows little to no recent Medicaid volume — the 100 capsules pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 68382-0559-30?

NDC 68382-0559-30 is a 100-count package — 10 blister pack in 1 carton / 10 capsule in 1 blister pack.

What is the difference between NDC 68382-0559-30 and NDC 68382-0559-01?

Both are nitrofurantoin macrocrystals 50 mg Capsule — the drug itself is identical. NDC 68382-0559-30 is the 100-count package, while NDC 68382-0559-01 is the 100 capsules package.

What NDC number is used to bill for this package of nitrofurantoin macrocrystals 50 mg Capsule?

Bill NDC 68382-0559-30 — the 11-digit billing format is 68382055930. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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	✓ 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.

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 68382-559-30, 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: 68382-0559-30, written without dashes as 68382055930. 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 68382-0559-30, the first segment (68382) is the labeler code FDA assigned to Zydus Pharmaceuticals (USA) Inc.; the middle segment (0559) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 Zydus Pharmaceuticals (USA) 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 100 capsules (68382-0559-01), 1000 capsules (68382-0559-10). 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?

Zydus Pharmaceuticals (USA) 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description

🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE: Nitrofurantoin macrocrystals capsules are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli , enterococci, Staphylococcus aureus , and certain susceptible strains of Klebsiella and Enterobacter species. 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 macrocrystals capsules and other antibacterial drugs, nitrofurantoin macrocrystals capsules 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 macrocrystals capsules are predisposed to persistence or reappearance of bacteriuria. 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 macrocrystals capsules, other therapeutic agents with broader tissue distribution should be selected.

In considering the use of nitrofurantoin macrocrystals capsules, 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 149 words ▾

DOSAGE AND ADMINISTRATION: Nitrofurantoin macrocrystals capsules should be given with food to improve drug absorption and, in some patients, tolerance. Adults: 50 to 100 mg four times a day -- the lower dosage level is recommended for uncomplicated urinary tract infections. Pediatric Patients: 5 to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age).

Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for reevaluation. For long-term suppressive therapy in adults, a reduction of dosage to 50 to 100 mg at bedtime may be adequate.

For long-term suppressive therapy in pediatric patients, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate. SEE WARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.

⛔ 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 macrocrystals capsules are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. Nitrofurantoin macrocrystals capsules 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 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 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: Respiratory: CHRONIC, SUBACUTE, OR ACUTE PULMONARY HYPERSENSITIVITY REACTIONS MAY OCCUR. CHRONIC PULMONARY REACTIONS OCCUR GENERALLY 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 ). 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, nystagmus, dizziness, headache, and drowsiness 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. Dermatologic: Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson syndrome) have been reported rarely.

Transient alopecia also has been reported. Allergic: A lupus-like syndrome associated with pulmonary reactions to nitrofurantoin has been reported. Also, angioedema; maculopapular, erythematous, or eczematous eruptions; pruritus; urticaria; anaphylaxis; arthralgia; myalgia; drug fever; chills; and vasculitis (sometimes associated with pulmonary reactions) have been reported.

Hypersensitivity reactions represent the most frequent spontaneously-reported adverse events in worldwide postmarketing experience with nitrofurantoin formulations. Gastrointestinal: Nausea, emesis, and anorexia occur most often. Abdominal pain and diarrhea are less common gastrointestinal reactions.

These dose-related reactions can be minimized by reduction of dosage. Sialadenitis and pancreatitis have been reported. 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 ). Hematologic: Cyanosis secondary to methemoglobinemia has been reported rarely. Miscellaneous: As with other antimicrobial agents, superinfections caused by resistant organisms, e.g., Pseudomonas species or Candida species, can occur.

Laboratory Advers…

🆘 Overdosage 47 words ▾

OVERDOSAGE: Occasional incidents of acute overdosage of nitrofurantoin macrocrystals 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. It is dialyzable.

🧬 Clinical Pharmacology 105 words ▾

CLINICAL PHARMACOLOGY: Nitrofurantoin macrocrystals is a larger crystal form of nitrofurantoin. The absorption of nitrofurantoin macrocrystals is slower and its excretion somewhat less when compared to nitrofurantoin. Blood concentrations at therapeutic dosage are usually low.

It is highly soluble in urine, to which it may impart a brown color. Following a dose regimen of 100 mg q.i.d. for 7 days, average urinary drug recoveries (0 to 24 hours) on day 1 and day 7 were 37.9% and 35%. Unlike many drugs, the presence of food or agents delaying gastric emptying can increase the bioavailability of nitrofurantoin macrocrystals, presumably by allowing better dissolution in gastric juices.

📦 How Supplied / Storage and Handling 186 words ▾

HOW SUPPLIED: Nitrofurantoin Capsules, USP (Macrocrystals) 50 mg are light yellow to yellow powder filled in size "3" empty hard gelatin capsules with blue opaque colored cap and white opaque colored body imprinted with '559' in black ink and are supplied as follows: NDC 68382-559-01 in bottles of 100 capsules NDC 68382-559-10 in bottles of 1000 capsules NDC 68382-559-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Nitrofurantoin Capsules, USP (Macrocrystals) 100 mg are light yellow to yellow powder filled in size "2" empty hard gelatin capsules with blue opaque colored cap and blue opaque colored body imprinted with '560' in black ink and are supplied as follows: NDC 68382-560-01 in bottles of 100 capsules NDC 68382-560-10 in bottles of 1000 capsules NDC 68382-560-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] .

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 10/22

📋 Description 152 words ▾

DESCRIPTION: Nitrofurantoin capsules, USP (macrocrystals) is a synthetic chemical of controlled crystal size. It is a stable, lemon-yellow, crystalline compound. Nitrofurantoin capsules, USP (macrocrystals) is an antibacterial agent for specific urinary tract infections.

It is available in 50 mg and 100 mg capsules for oral administration. 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione Nitrofurantoin macrocrystals is a lemon-yellow crystalline compound. It is soluble in dimethylformamide, very slightly soluble in water and in alcohol.

Each nitrofurantoin capsules, USP (macrocrystals) intended for oral administration contains 50 mg and 100 mg of nitrofurantoin macrocrystals. In addition, each capsule contains the following inactive ingredients: gelatin, lactose monohydrate, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally each 50 mg and 100 mg capsule shell contains FD & C Blue # 1, FD & C Red # 3 and sodium lauryl sulphate.

The capsule is printed with black pharmaceutical ink which contains black iron oxide, potassium hydroxide, propylene glycol and shellac. figure

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.

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.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

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.

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.

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

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.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

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.

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

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.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

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

exfoliative dermatitis: Widespread redness with heavy scaling or peeling of the skin over most of the body.

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.

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.

methemoglobinemia: A condition where the blood carries less oxygen than normal because of a change in its oxygen-carrying protein.

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.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

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

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 ↗

🔗 Related NDC lookups

🧪 All Nitrofurantoin Macrocrystals NDCsSame ingredient 🏭 All Zydus labeler NDCsLabeler code 68382 📚 All Nitrofuran Antibacterial NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Nitrofuran Derivatives Antibacterial Agents.

Nitrofurantoin Monohyd/M-Cryst 00185-0122-01 Nitrofurantoin 00472-1992-08

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Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

nitrofurantoin macrocrystals 50 mg Capsule, 100-count

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