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Nitrofurantoin 50 mg/5mL Suspension — NDC 16571-0888-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nitrofurantoin 50 mg/5mL Suspension — NDC 16571-888-06 (Billing 16571-0888-06)

by Rising Pharma Holdings, Inc. · 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE

This is a package of Nitrofurantoin 50 mg/5mL Suspension from Rising Pharma Holdings, Inc., marketed since Feb 2024 and currently FDA-listed. It is this product's only package size.

NDC 16571-0888-06
🏷️ FDA NDC (as labeled) 16571-888-06 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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) 16571-888-06
Product NDC 16571-888
11-digit billing NDC 16571088806
NCPDP billing unit ML — per mL (volume)
RxCUI 311989, 422434
UNII 927AH8112L
Application # NDA009175
SPL Set ID 89095f4d-e142-465e-b378-da24f6eeaf2b
Established class (EPC) Nitrofuran Antibacterial
Chemical class Nitrofurans
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-02-01
Route ORAL
Dosage form SUSPENSION
Substance NITROFURANTOIN

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

GPI-14 16800050001820
GCN Seq No 027017
GCN 41872
HICL code 004089
Ingredient (HICL) Nitrofurantoin
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 50 MG/5 ML SUSP
FDB brand name Nitrofurantoin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 027017
  • GCN: 41872
  • GPI-14 (Medi-Span): 16800050001820
  • HICL (First Databank): 004089
  • AHFS class code: 08:36.00.00
  • RxCUI (RxNorm): 311989
Why two NDCs? The FDA registers this code as 16571-888-06 — 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 → 16571-0888-06. 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 50 MG/5 ML SUSP Ingredient Nitrofurantoin
📖 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 ↗
📗 Our plain-language guide HelloPharmacist
  • Nitrofurantoin is an antibiotic specifically for urinary tract infections — think bladder infections, not kidney infections. It works by concentrating in your urine where it kills...
  • What exactly is nitrofurantoin used for?
  • Yes, every time. Taking nitrofurantoin with food isn't just about avoiding an upset stomach — food actually helps your body absorb more of the medication, so it works better. Even...
  • Do I really need to take it with food every single time?
📖 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.

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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $37.13 $2,227.97 / 60 ml
Medicare drug plans payPart D · Q2 2026 $43.40 $2,603.86 / 60 ml
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
16571-0888-06 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE 2023-06-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nitrofurantoin 50 mg/5mLthis 16571-0888-06 Rising 1 bottle — — FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
2024
On the market since
Feb 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 Yellow
FlavorRaspberry
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 K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 6M3P64V0NC
    A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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.

Manufacturer & labeler

LabelerRising Pharma Holdings, Inc.
Application holderCASPER PHARMA LLC
FDA applicationNDA009175 (NDA AUTHORIZED GENERIC)
Labeler code16571
First marketedFeb 2024
Product typeHuman Prescription Drug
Portfolio525 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS & USAGE Nitrofurantoin oral suspension is indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections due to susceptible strains of Escherichia coli, Enterococcus species , Staphylococcus aureus, Klebsiella species and Enterobacter species. Limitations of Use Nitrofurantoin oral suspension is not indicated for the treatment of pyelonephritis or perinephric abscesses [see Warnings and Precautions (5.7) ]. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin oral suspension and other antibacterial drugs, nitrofurantoin oral suspension 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. Nitrofurantoin is a nitrofuran antibacterial indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections caused by susceptible bacteria.

(1) Limitations of Use Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. (1) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin oral suspension and other antibacterial drugs, nitrofurantoin oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE & ADMINISTRATION Adult Patients: 50 mg to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections. (2.2) Pediatric Patients: 5 mg/kg to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age). (2.3)

2.1Recommended Dosage and Administration in Adult Patients The recommended dosage is 50 mg to 100 mg of nitrofurantoin oral suspension four times a day. For long-term suppressive therapy in adults, a reduction of dosage to 50 mg to 100 mg at bedtime may be adequate. The benefits of long-term suppressive therapy should be balanced against the increased potential for systemic toxicity and for the development of antibacterial resistance [see Warnings and Precautions ( 5.2 , 5.4 , 5.6 )].

Administer nitrofurantoin oral suspension with food to improve drug absorption [see Clinical Pharmacology ( 12.3 )] and, in some patients, tolerance.

2.2Recommended Dosage and Administration in Pediatric Patients (1 month of age and older) The recommended dosage of nitrofurantoin oral suspension is 5 mg/kg to 7 mg/kg of body weight per 24 hours, given in four divided doses in pediatric patients aged 1 month and older. Administer nitrofurantoin oral suspension with food to improve drug absorption [see Clinical Pharmacology ( 12.3 )] and, in some patients, tolerance. Table 1 lists individual dosage volumes for two different strengths of nitrofurantoin oral suspension (25 mg/5 mL and 50 mg/5 mL) based on body weight for pediatric patients.

Table 1: Nitrofurantoin Oral Suspension Pediatric Dosing Table for Pediatric Patients 1 month of Age and Older To measure the correct pediatric doses, it is important to administer nitrofurantoin oral suspension with an appropriate size oral dosing syringe with graduations that align with the volume prescribed in Table 1 above. Continue therapy 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 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 and Precautions ( 5.2 , 5.4 , 5.6 )]. nitrofurantoin-table1

💊 Dosage Forms and Strengths 37 words ▾

3 DOSAGE FORMS & STRENGTHS Nitrofurantoin oral suspension is available as an opaque, yellow liquid oral suspension containing 25 mg/5 mL and 50 mg/5 mL of nitrofurantoin. Oral Suspension: 25 mg/5 mL and 50 mg/5 mL. (3)

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS Nitrofurantoin oral suspension is contraindicated in: • patients with known hypersensitivity to nitrofurantoin [see Warnings and Precautions ( 5.1 )]. • patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin [see Warnings and Precautions ( 5.3 )]. • patients who have anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) due to an increased risk of toxicity resulting from impaired excretion of the drug [see Warnings and Precautions ( 5.4 )]. • pregnant patients at term (38 weeks to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent and in pediatric patients younger than 1 month of age because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability) [see Warnings and Precautions ( 5.5 ) and Use in Specific Populations ( 8.1 and 8.4 )]. • Known hypersensitivity to nitrofurantoin.

( 4 ) • History of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. ( 4 ) • Patients who have anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine). ( 4 ) • Pregnant patients at term (38 weeks to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent.

( 4 ) • Pediatric Patients under one month of age. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving nitrofurantoin oral suspension. If signs and symptoms of a hypersensitivity reaction occurs, immediately discontinue nitrofurantoin oral suspension. ( 5.1 ) • Pulmonary Reactions: Discontinue if sign and symptoms of pulmonary reactions occur and take appropriate measures.

( 5.2 ) • Hepatotoxicity: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests. ( 5.3 ) • Neuropathy: Peripheral neuropathy has occurred.

( 5.4 ) • Hemolytic Anemia: Discontinue if sign and symptoms of hemolysis occur. ( 5.5 ) • Clostridioides difficile -associated diarrhea: Evaluate patients if diarrhea occurs. ( 5.6 )

5.1Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving nitrofurantoin oral suspension [see Adverse Reactions ( 6 )] . If signs and symptoms of a hypersensitivity reaction occurs, immediately discontinue nitrofurantoin oral suspension and initiate appropriate medications and/or supportive care. Nitrofurantoin oral suspension is contraindicated in patients with known hypersensitivity to nitrofurantoin.

5.2Pulmonary Reactions Acute, subacute, or chronic pulmonary reactions have been reported in patients treated with nitrofurantoin. If these reactions occur, discontinue nitrofurantoin and take appropriate measures. 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 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 Adverse Reactions (6 )].

5.3Hepatotoxicity Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, has occurred. Fatalities have been reported. The onset of chronic active hepatitis may be insidious. Monitor patients periodically for changes in biochemical tests that would indicate liver injury. If hepatitis occurs, discontinue nitrofurantoin oral suspension immediately, and take appropriate measures.

5.4Neuropathy 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.

Monitor patients receiving long-term therapy periodically for changes in renal function. Optic neuritis has been reported with nitrofurantoin formulations [see Adverse Reactions (6) ].

5.5Hemolytic 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.

If hemolysis occurs, discontinue nitrofurantoin oral suspension immediately; hemolysis ceases when the drug is withdrawn.

5.6Clostridioides difficile -associated Diarrhea Clostridioides difficile -associated Diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including nitrofurantoin oral suspension, 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 produci… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • Pulmonary Reactions [see Warnings and Precautions (5.2) ] • Hepatotoxicity [see Warnings and Precautions (5.3) ] • Neuropathy [see Warnings and Precautions (5.4) ] • Hemolytic anemia [see Warnings and Precautions (5.5) ] • Clostridioides difficile -associated Diarrhea [see Warnings and Precautions (5.6) ] • Persistence or Reappearance of Bacteriuria [see Warnings and Precautions (5.7) ] The following adverse reactions associated with the use of nitrofurantoin formulations, including, nitrofurantoin oral suspension were identified in clinical studies or post-marketing reports.

Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Respiratory : chronic, subacute, or acute pulmonary hypersensitivity reactions have occurred. Chronic pulmonary reactions have occurred 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 prominent.

The severity of chronic pulmonary reactions and their degrees 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 of 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.

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. Hepatic : Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, have occurred.

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.

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. 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. 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; and vasculitis (sometimes associated with pulmonary rea… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 185 words ▾

7 DRUG INTERACTIONS Antacids: Decreased absorption of nitrofurantoin. (7.1) Uricosuric drugs: Inhibit renal tubular secretion of nitrofurantoin. (7.2)

7.1Antacids 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. If coadministration of nitrofurantoin with antacids containing magnesium trisilicate cannot be avoided, monitor for lack of efficacy [see Clinical Pharmacology (12.3) ].

7.2Uricosuric Drugs 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. Therefore, monitor for nitrofurantoin adverse reactions when co-administering nitrofurantoin oral suspension with uricosuric drugs.

7.3Drug Interference with Laboratory Tests The presence of nitrofurantoin can cause a false-positive reaction for glucose in the urine when using Benedict's or Fehling's copper reduction reaction to determine the amount of reducing substances like glucose in the urine. Use glucose tests based on enzymatic glucose oxidase reactions to detect glucose in the urine.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Lactation: Breastfeeding is not recommended in infants under one month of age or with glucose-6-phosphate dehydrogenase (G6PD) deficiency. ( 8.2 ) • Pediatric Use: Nitrofurantoin oral suspension is contraindicated in pediatric patients under one month of age. ( 8.4 )

8.1Pregnancy Risk Summary Nitrofurantoin is contraindicated in pregnant women at term (38 weeks to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent because of the possibility of hemolytic anemia in the infant (see Clinical Considerations ). Published epidemiological studies, including cohort studies and case control studies, have reported inconsistent findings related to nitrofurantoin use during the first trimester and risk of major birth defects. These studies cannot definitively establish the presence or absence of risk due to several methodological limitations.

The limited number of epidemiological studies available have not identified drug-associated risks of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, no fetotoxicity was observed when nitrofurantoin was administered orally to pregnant rats and rabbits, during organogenesis, at up to 6 times the recommended human dose (see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Nitrofurantoin is not recommended in pregnant women at term (38 weeks to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability) [see Contraindications (4) and Warnings and Precautions (5.4) ].

Data Animal Data Several reproduction studies have been performed in rabbits and rats at doses up to six times the human dose and have revealed no 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.

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.

8.2Lactation Risk Summary Nitrofurantoin is present in human breast milk following oral administration. There are insufficient data on the effect of nitrofurantoin on milk production. Infants less than one month of age or who have glucose-6-phosphate dehydrogenase (G6PD) deficiency are at risk for hemolytic anemia from nitrofurantoin exposure.

Therefore, breastfeeding is not recommended in these infants. In a breastfed infant over the age of one month and with normal G6PD, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for nitrofurantoin and any potential adverse effects on the breastfed infant from nitrofurantoin or from the underlying maternal condition. Monitor these infants for vomiting, diarrhea, and rash.

8.3Females and Males of Reproductive Potential Infertility Male Based on findings from a fertility study conducted in 36 healthy male volunteers and an animal fertility study, nitrofurantoin may reversibly decrease spermatogenesis [see Nonclinical Toxicology (13.1) ]. Nitrofurantoin doses of 10 mg/kg/day or greater in healthy human males may produce a slight to moderate spermatogenic a… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Nitrofurantoin is contraindicated in pregnant women at term (38 weeks to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent because of the possibility of hemolytic anemia in the infant (see Clinical Considerations ). Published epidemiological studies, including cohort studies and case control studies, have reported inconsistent findings related to nitrofurantoin use during the first trimester and risk of major birth defects. These studies cannot definitively establish the presence or absence of risk due to several methodological limitations.

The limited number of epidemiological studies available have not identified drug-associated risks of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, no fetotoxicity was observed when nitrofurantoin was administered orally to pregnant rats and rabbits, during organogenesis, at up to 6 times the recommended human dose (see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Nitrofurantoin is not recommended in pregnant women at term (38 weeks to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability) [see Contraindications (4) and Warnings and Precautions (5.4) ].

Data Animal Data Several reproduction studies have been performed in rabbits and rats at doses up to six times the human dose and have revealed no 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.

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.

🧒 Pediatric Use 67 words ▾

8.4Pediatric Use Nitrofurantoin oral suspension is contraindicated in pediatric patients younger than 1 month of age because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability). [see Contraindications (4) and Warnings and Precautions (5.4) ]. The safety and effectiveness of nitrofurantoin in pediatric patients aged 1 month of age and older for the treatment of urinary tract infections have been established.

🆘 Overdosage 43 words ▾

10 OVERDOSAGE Incidents of acute overdosage of nitrofurantoin have resulted in symptoms such as 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 ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Nitrofurantoin is an antibacterial drug [ see Microbiology (12.4) ].

12.2Pharmacodynamics Pharmacodynamic effects of nitrofurantoin are unknown.

12.3Pharmacokinetics Absorption Orally administered nitrofurantoin is readily absorbed. Blood concentrations at therapeutic dosage are usually low. Effect of Food The presence of food or agents delaying gastric emptying can increase the bioavailability of nitrofurantoin.

Distribution Nitrofurantoin is highly soluble in urine. Nitrofurantoin lacks the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Elimination Excretion Nitrofurantoin is rapidly excreted in urine, to which it may impart a brown color.

Following a dose regimen of 100 mg four times a day for 7 days, average urinary drug recoveries (0 hour to 24 hours) on Day 1 and Day 7 were 42.7% and 43.6%. Nitrofurantoin is dialyzable. Specific Populations The pharmacokinetics of nitrofurantoin oral suspension are unknown for the geriatric patients, pediatric patients, patients with hepatic impairment, or pregnant women.

Differences between male and female patients, and racial or ethnic groups are unknown. Patients with Renal Impairment The reported urinary recoveries of nitrofurantoin after a single 100 mg oral dose and 100 mg four times a day in patients with varying renal function showed approximate linear relationship between the amount of nitrofurantoin recovered and creatinine clearance. Drug Interaction Studies Antacids such as magnesium trisilicate In a cross-over study, the in vivo absorption characteristics of nitrofurantoin and nitrofurantoin-magnesium trisilicate combination were evaluated in 6 healthy males.

The administration of 5 g magnesium trisilicate with 100 mg nitrofurantoin reduced the rate and extent of nitrofurantoin excretion reflecting decrease in both rate and extent of its absorption [see Drug Interaction (7.1) ]. Propantheline In a crossover study, the in vivo absorption characteristics of nitrofurantoin and propantheline (an anticholinergic agent) combination were evaluated in six subjects. Administration of 30 mg of propantheline 45 min prior to nitrofurantoin 100 mg administration resulted in a statistically significant increase in nitrofurantoin excretion, however, the clinical significance of this effect is unknown.

12.4Microbiology Mechanism of Action Nitrofurantoin is reduced by a wide range of enzymes including bacterial flavoproteins to reactive intermediates which are damaging to macromolecules such as DNA and proteins. Resistance Nitrofurantoin is not active against most strains of Proteus species or Serratia species. It has no activity against Pseudomonas species.

Although cross-resistance with other antibacterials may occur, cross resistance with sulfonamides has not been observed. Interaction with Other Antibacterials Antagonism has been demonstrated in vitro between nitrofurantoin and quinolones. Antibacterial Activity Nitrofurantoin has been shown to be active against most of the following bacteria both in vitro and in clinical infections: Aerobic bacteria Gram-positive bacteria Staphylococcus aureus Enterococcus species Gram-negative bacteria Escherichia coli Enterobacter species Klebsiella species The following in vitro data are available, but their clinical significance is unknown.

Nitrofurantoin exhibits in vitro activity against the following bacteria; however, the safety and efficacy of nitrofurantoin in treating clinical infections due to these bacteria have not been established in adequate and well-controlled clinical trials. Aerobic bacteria Gram-positive bacteria Coagulase-negative staphylococci (including Staphylococcus epidermidis and Staphylococcus saprophyticus ) Streptococcus agalactiae Viridans group streptococci Gram-negative bacteria Citrobacter koseri Citrobacter freundii Klebsiella oxytoca Susceptibility Testing For specific information regarding susceptibility test interpre… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 14 words ▾

12.1Mechanism of Action Nitrofurantoin is an antibacterial drug [ see Microbiology (12.4) ].

📦 How Supplied / Storage and Handling 98 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Nitrofurantoin oral suspension (25 mg/5 mL) is available in: NDC 16571-740-24 PET amber bottle of 230 mL Nitrofurantoin oral suspension (50 mg/5 mL) is available in: NDC 16571-888-06 PET amber bottle of 60 mL Storage and Handling Avoid exposure to strong light which may darken the drug. It is stable when stored between 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from freezing.

Shake vigorously. Dispense in tight, light-resistant, plastic (PET) or glass container. Use within 30 days.

📋 Description 106 words ▾

11 DESCRIPTION Nitrofurantoin oral suspension contains nitrofurantoin, a synthetic nitrofuran antibacterial agent specific for urinary tract infections. The chemical name is 1-[[(5-nitro-2-furanyl)methylene]amino]-2,4-imidazolidinedione monohydrate. The molecular formula is C 8 H 6 N 4 O 5 ꞏH 2 O and the molecular weight is 256.17.

The structural formula is: Nitrofurantoin is a stable, yellow, crystalline compound. Nitrofurantoin oral suspension is available as an opaque, yellow liquid suspension for oral administration containing 25 mg/5 mL and 50 mg/5 mL of nitrofurantoin. Nitrofurantoin oral suspension also contains the following inactive ingredients: carboxymethylcellulose sodium, citric acid, flavors, glycerin, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium citrate, and sorbitol. nitrofurantoin-structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Administration Instructions Instruct the patients to: • complete the full course of therapy; however, advise the patients or their caregiver to contact their physician if any unusual symptoms occur during therapy. • take daily doses of nitrofurantoin oral suspension with food, as food will further enhance tolerance and improve the absorption of the drug. • shake nitrofurantoin oral suspension vigorously before use each time. • use an oral dosing syringe to correctly measure the prescribed amount of nitrofurantoin oral suspension.

Inform patients or caregivers that an appropriate size oral dosing syringe with graduations that align with the volume prescribed may be obtained from their pharmacy. Serious Allergic Reactions Advise patients that allergic reactions, including serious allergic reactions, could occur with nitrofurantoin oral suspension and that serious reactions require immediate treatment. Advise patients to discontinue nitrofurantoin oral suspension at the first sign of allergic reactions [see Warnings and Precautions (5.1) ].

Diarrhea Advise patients that diarrhea is a common problem caused by antibacterial drugs, including nitrofurantoin oral suspension which usually ends when the antibacterial drug is discontinued. Sometimes frequent watery and bloody diarrhea (with or without stomach cramps and fever) may occur even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, advise patients to contact their physician as soon as possible [see Warnings and Precautions (5.6) ].

Drug Interactions with Antacids Advise patients not to use antacid preparations containing magnesium trisilicate while taking nitrofurantoin oral suspension [see Drug Interactions (7.1) ]. Lactation Advise women not to breastfeed infants who are less than one month of age or who have G6PD deficiency during treatment with nitrofurantoin oral suspension [see Use in Specific Populations (8.2) ]. Antibacterial Resistance Patients should be counseled that antibacterial drugs including nitrofurantoin should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold). When nitrofurantoin oral suspension is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of the 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 or other antibacterial drugs in the future.

Change in Urine Color Inform patients that nitrofurantoin oral suspension may impart a brown color to their urine [see Clinical Pharmacology (12.3) ]. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Made in India Code: AP/DRUGS/04/2016 Revised: 02/2024 PIA88806-01

🍼 Nursing Mothers 68 words ▾

8.3Females and Males of Reproductive Potential Infertility Male Based on findings from a fertility study conducted in 36 healthy male volunteers and an animal fertility study, nitrofurantoin may reversibly decrease spermatogenesis [see Nonclinical Toxicology (13.1) ]. Nitrofurantoin doses of 10 mg/kg/day or greater in healthy human males may produce a slight to moderate spermatogenic arrest with a decrease in sperm count. The effect on fertility is unknown.

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Absorption Orally administered nitrofurantoin is readily absorbed. Blood concentrations at therapeutic dosage are usually low. Effect of Food The presence of food or agents delaying gastric emptying can increase the bioavailability of nitrofurantoin.

Distribution Nitrofurantoin is highly soluble in urine. Nitrofurantoin lacks the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Elimination Excretion Nitrofurantoin is rapidly excreted in urine, to which it may impart a brown color.

Following a dose regimen of 100 mg four times a day for 7 days, average urinary drug recoveries (0 hour to 24 hours) on Day 1 and Day 7 were 42.7% and 43.6%. Nitrofurantoin is dialyzable. Specific Populations The pharmacokinetics of nitrofurantoin oral suspension are unknown for the geriatric patients, pediatric patients, patients with hepatic impairment, or pregnant women.

Differences between male and female patients, and racial or ethnic groups are unknown. Patients with Renal Impairment The reported urinary recoveries of nitrofurantoin after a single 100 mg oral dose and 100 mg four times a day in patients with varying renal function showed approximate linear relationship between the amount of nitrofurantoin recovered and creatinine clearance. Drug Interaction Studies Antacids such as magnesium trisilicate In a cross-over study, the in vivo absorption characteristics of nitrofurantoin and nitrofurantoin-magnesium trisilicate combination were evaluated in 6 healthy males.

The administration of 5 g magnesium trisilicate with 100 mg nitrofurantoin reduced the rate and extent of nitrofurantoin excretion reflecting decrease in both rate and extent of its absorption [see Drug Interaction (7.1) ]. Propantheline In a crossover study, the in vivo absorption characteristics of nitrofurantoin and propantheline (an anticholinergic agent) combination were evaluated in six subjects. Administration of 30 mg of propantheline 45 min prior to nitrofurantoin 100 mg administration resulted in a statistically significant increase in nitrofurantoin excretion, however, the clinical significance of this effect is unknown.

🧬 Pharmacodynamics 8 words ▾

12.2Pharmacodynamics Pharmacodynamic effects of nitrofurantoin are unknown.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Carcinogenesis 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 BDF 1 mice revealed no evidence of carcinogenicity. Nitrofurantoin presented evidence of carcinogenic activity in female B6C3F 1 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. The significance of carcinogenicity findings relative to the therapeutic use of nitrofurantoin in humans is unknown. Mutagenesis 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 and chromosomal aberrations in Chinese hamster ovary cells but not in human cells in culture. Results of the sex-linked recessive lethal assay in Drosophila were negative after administration of nitrofurantoin by feeding or by injection. Nitrofurantoin did not induce heritable mutation in the rodent models examined.

The significance of mutagenicity findings relative to the therapeutic use of nitrofurantoin in humans is unknown. Impairment of Fertility The administration of high doses of nitrofurantoin to rats causes temporary spermatogenic arrest; this is reversible on discontinuing the drug.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Carcinogenesis 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 BDF 1 mice revealed no evidence of carcinogenicity. Nitrofurantoin presented evidence of carcinogenic activity in female B6C3F 1 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. The significance of carcinogenicity findings relative to the therapeutic use of nitrofurantoin in humans is unknown. Mutagenesis 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 and chromosomal aberrations in Chinese hamster ovary cells but not in human cells in culture. Results of the sex-linked recessive lethal assay in Drosophila were negative after administration of nitrofurantoin by feeding or by injection. Nitrofurantoin did not induce heritable mutation in the rodent models examined.

The significance of mutagenicity findings relative to the therapeutic use of nitrofurantoin in humans is unknown. Impairment of Fertility The administration of high doses of nitrofurantoin to rats causes temporary spermatogenic arrest; this is reversible on discontinuing the drug.

📄 Recent Major Changes 7 words ▾

Dosage and Administration ( 2 ) 1/2024

📄 Package Label / Principal Display Panel 50 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Rising ® NDC 16571-740-24 Nitrofurantoin Oral Suspension 25 mg/5 mL Urinary Tract Antibacterial 230 mL Rx only Carton label Container Label Rising ® NDC 16571-888-06 Nitrofurantoin Oral Suspension 50 mg/5 mL Urinary Tract Antibacterial 60 mL Rx only Carton label Container label nitrofurantoin-carton-01 nitrofurantoin-container-01 nitrofurantoin-carton-02 nitrofurantoin-container-02

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
3.1K
Units reimbursed last 4 qtrs
435.5K
Gross reimbursed last 4 qtrs
$16.17M
Avg / prescription
$5,157.85
Avg / unit
$37.1329
Latest quarter Q1 2026
1.2KRx
Fee-for-service vs managed care ⓘ
66% FFS 34% MCO
Fee-for-service · 2,062 Rx Managed care · 1,073 Rx
State Medicaid map
Alaska: no data reported AK Maine: 2,080 units · 149 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 255,841 units · 1,307 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 45,910 units · 1,437 per 100k residents NV Wyoming: 1,680 units · 288 per 100k residents WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 16,364 units · 130 per 100k residents IL Indiana: no data reported IN Ohio: 13,774 units · 117 per 100k residents OH Pennsylvania: 2,030 units · 15.7 per 100k residents PA New Jersey: 741 units · 8.0 per 100k residents NJ Massachusetts: 1,548 units · 22.1 per 100k residents MA California: 9,664 units · 24.8 per 100k residents CA Utah: no data reported UT Colorado: 3,559 units · 60.5 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 6,428 units · 142 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 1,814 units · 50.2 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 2,700 units · 91.8 per 100k residents KS Arkansas: no data reported AR Tennessee: 14,902 units · 209 per 100k residents TN North Carolina: 20,854 units · 192 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 12,029 units · 235 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 20,112 units · 65.9 per 100k residents TX Florida: 3,430 units · 15.2 per 100k residents FL
Units reimbursed · per 100k residents
8.01,437
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 Nevada 1,437 /100k
2 New York 1,307 /100k
3 Wyoming 288 /100k
4 Alabama 235 /100k
5 Tennessee 209 /100k
6 North Carolina 192 /100k
7 Maine 149 /100k
8 Kentucky 142 /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.

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.

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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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) ✓ Available
“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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Rising Pharma Holdings, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Rising Pharma Holdings, 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.
← 16571-0887-01 · Rising 16571-0889-09 · Rising →
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.