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Fidaxomicin 200 mg Tablet, Film Coated, 20-count — NDC 13668-0745-21 package photo
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Fidaxomicin 200 mg Tablet, Film Coated, 20-count — NDC 13668-745-21 (Billing 13668-0745-21)

by Torrent Pharmaceuticals Limited · 20 TABLET, FILM COATED in 1 BOTTLE

This is a package of 20 tablets of Fidaxomicin 200 mg Tablet, Film Coated from Torrent Pharmaceuticals Limited, marketed since Jan 2026 and currently FDA-listed; retail pharmacies pay about $90.50 per tablet (NADAC). It is this product's only package size.

NDC 13668-0745-21
🏷️ FDA NDC (as labeled) 13668-745-21 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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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) 13668-745-21
Product NDC 13668-745
11-digit billing NDC 13668074521
NCPDP billing unit EA — each (per item)
RxCUI 1111106
UNII Z5N076G8YQ
UPC 0313668745214
Application # ANDA220374
SPL Set ID 8f68f0cb-9573-4d5a-8f31-a93dd2706691
Established class (EPC) Macrolide Antibacterial
Chemical class Macrolides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-27
Route ORAL
Dosage form TABLET, FILM COATED
Substance FIDAXOMICIN
TE code (Orange Book) AB · RLD · RS

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

GPI-14 03530025000320
GCN Seq No 067471
GCN 30035
HICL code 037674
Ingredient (HICL) Fidaxomicin
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1D
Therapeutic class — specific (HIC3) Macrolide Antibiotics
AHFS code 08:12.12.08
AHFS class Other Macrolide Antibiotics
FDB label name FIDAXOMICIN 200 MG TABLET
FDB brand name Fidaxomicin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 067471
  • GCN: 30035
  • GPI-14 (Medi-Span): 03530025000320
  • HICL (First Databank): 037674
  • AHFS class code: 08:12.12.08
  • RxCUI (RxNorm): 1111106
Why two NDCs? The FDA registers this code as 13668-745-21 — 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 → 13668-0745-21. 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 Macrolide Antibacterial class.

Pharmacologic class Macrolide Antibacterial
Drug family (ATC) Antibiotics
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 FIDAXOMICIN 200 MG TABLET Ingredient Fidaxomicin
📗 Our plain-language guide HelloPharmacist
  • Fidaxomicin treats diarrhea caused by a C. difficile infection in your gut. It only works for this infection, not for other kinds.
  • Take it by mouth twice a day for 10 days, with or without food. Finish the full course as your prescriber directs, even if you start feeling better.
  • The most common are nausea, vomiting and belly pain. Some people also have gut bleeding, anemia or low white blood cells. Let your doctor know if anything bothers you or worsens.
  • Get help right away if you have trouble breathing or swelling of your face, mouth or throat. Also call if you get a rash or itching. These could be signs of an allergic reaction.
📖 Read our full Fidaxomicin guide →
7
Nutrient depletion considerations

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

🧪 Full Fidaxomicin 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 eaPer package
Retail pharmacies payNADAC · weekly $90.505 $1,810.09 / 20 tablets
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 $196.45 $3,928.93 / 20 tablets
NADAC price history (per ea) — tap or hover for the price & month
Mar 2026 May 2026 Jul 2026 Sep 2026 $193.665 $90.505
▼ Down 53% over the last 7 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
13668-0745-21 You're viewing this Main listing 20 TABLET, FILM COATED in 1 BOTTLE 2026-01-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fidaxomicin 200 mg 00480-2596-34 Teva 20 tablets $90.505 AB Availability likely —
Fidaxomicin 200 mgthis 13668-0745-21 Torrent 20 tablets $90.505 AB Availability likely —
Fidaxomicin 200 mg 60505-4833-02 Apotex 20 tablets $90.505 AB Availability likely —
Dificid 200 mg 52015-0080-01 Merck 20 tablets $248.379 AB Availability likely +174%
Fidaxomicin 200 mg 00781-5194-20 Sandoz 20 tablets — 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

🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

What it looks like

Color white
Shapecapsule
Imprint2F
Size14 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 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • 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.

11 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

LabelerTorrent Pharmaceuticals Limited
Application holderTORRENT PHARMACEUTICALS LTD
FDA applicationANDA220374 (ANDA)
Labeler code13668
First marketedJan 2026
Product typeHuman Prescription Drug
Portfolio182 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 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 198 words ▾

1 INDICATIONS AND USAGE Fidaxomicin is a macrolide antibacterial indicated in adult patients for the treatment of C. difficile -associated diarrhea. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of fidaxomicin tablets and other antibacterial drugs, fidaxomicin tablets should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile . ( 1.2 )

1.1Clostridioides difficile- Associated Diarrhea Fidaxomicin tablets are indicated in adult patients for the treatment of C. difficile - associated diarrhea (CDAD).

1.2Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of fidaxomicin tablets and other antibacterial drugs, fidaxomicin tablets should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile . 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.

Pediatric use information is approved for Cubist Pharmaceuticals LLC's DIFICID ® (fidaxomicin) tablets. However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that information.

⏱️ Dosage and Administration 108 words ▾

2 DOSAGE AND ADMINISTRATION • Fidaxomicin tablets are administered orally with or without food. ( 2.1 ) • Adults o One 200 mg tablet orally twice daily for 10 days. ( 2.2 )

2.1Important Administration Instructions Fidaxomicin tablets are available for oral administration as 200 mg tablets. Fidaxomicin tablets are administered orally with or without food.

2.2Adult Patients The recommended dosage for adults is one 200 mg fidaxomicin tablet orally twice daily for 10 days. Pediatric use information is approved for Cubist Pharmaceuticals LLC's DIFICID ® (fidaxomicin) tablets. However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that information.

💊 Dosage Forms and Strengths 36 words ▾

3 DOSAGE FORMS AND STRENGTHS Fidaxomicin tablets White to off white, capsule shaped, film coated tablets debossed with '2F' on one side and plain on the other side. • Film-coated tablets: 200 mg ( 3 )

⛔ Contraindications 49 words ▾

4 CONTRAINDICATIONS Fidaxomicin tablets are contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in fidaxomicin tablets [see Warnings and Precautions (5.1)] . Fidaxomicin tablets are contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in fidaxomicin tablets. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS • Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, and rash) have been reported. If a severe hypersensitivity reaction occurs, discontinue fidaxomicin tablets. ( 5.1 ) • Fidaxomicin tablets are not expected to be effective for the treatment of other types of infections due to minimal systemic absorption of fidaxomicin.

Fidaxomicin tablets should only be used for the treatment of C. difficile -associated diarrhea. ( 5.2 ) • Development of drug-resistant bacteria: Only use fidaxomicin tablets for infection proven or strongly suspected to be caused by C. difficile . ( 5.3 )

5.1Hypersensitivity Reactions Acute hypersensitivity reactions, including dyspnea, rash, pruritus, and angioedema of the mouth, throat, and face have been reported with fidaxomicin tablets. If a severe hypersensitivity reaction occurs, fidaxomicin tablets should be discontinued and appropriate therapy should be instituted. Some patients with hypersensitivity reactions to fidaxomicin tablets also reported a history of allergy to other macrolides.

Physicians prescribing fidaxomicin tablets to patients with a known macrolide allergy should be aware of the possibility of hypersensitivity reactions.

5.2Not for Use in Infections Other than C. difficile -Associated Diarrhea Fidaxomicin tablets are not expected to be effective for the treatment of other types of infections due to minimal systemic absorption of fidaxomicin [see Clinical Pharmacology (12.3)] . Fidaxomicin tablets has not been studied for the treatment of infections other than CDAD. Fidaxomicin tablets should only be used for the treatment of CDAD.

5.3Development of Drug-Resistant Bacteria Prescribing fidaxomicin tablets in the absence of proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions in adults (incidence ≥2%) are nausea, vomiting, abdominal pain, gastrointestinal hemorrhage, anemia, and neutropenia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc., at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults The safety of fidaxomicin 200 mg tablets taken twice a day for 10 days was evaluated in 564 adult patients with CDAD in two active-controlled trials with 86.7% of patients receiving a full course of treatment. Thirty-three adult patients receiving fidaxomicin tablets (5.9%) withdrew from trials as a result of adverse reactions (AR).

The types of AR resulting in withdrawal from the study varied considerably. Vomiting was the primary adverse reaction leading to discontinuation of dosing; this occurred at an incidence of 0.5% in both the fidaxomicin and vancomycin patients in Phase 3 trials. The most common selected adverse reactions occurring in ≥2% of adult patients treated with fidaxomicin tablets are listed in Table 2.

Table 2: Selected Adverse Reactions with an Incidence of ≥2% Reported in Fidaxomicin Tablets-Treated Adult Patients in Controlled Trials System Organ Class Adverse Reaction Fidaxomicin Tablets (N=564) Vancomycin (N=583) n (%) n (%) Blood and Lymphatic System Disorders Anemia 14 (2%) 12 (2%) Neutropenia 14 (2%) 6 (1%) Gastrointestinal Disorders Nausea 62 (11%) 66 (11%) Vomiting 41 (7%) 37 (6%) Abdominal Pain 33 (6%) 23 (4%) Gastrointestinal Hemorrhage 20 (4%) 12 (2%) The following adverse reactions were reported in <2% of adult patients taking fidaxomicin tablets in controlled trials: Gastrointestinal Disorders: abdominal distension, abdominal tenderness, dyspepsia, dysphagia, flatulence, intestinal obstruction, megacolon Investigations: increased blood alkaline phosphatase, decreased blood bicarbonate, increased hepatic enzymes, decreased platelet count Metabolism and Nutrition Disorders: hyperglycemia, metabolic acidosis Skin and Subcutaneous Tissue Disorders: drug eruption, pruritus, rash

6.2Post Marketing Experience The following adverse reactions have been identified during post-approval use of fidaxomicin tablets. Because these reactions are 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. Hypersensitivity reactions (dyspnea, angioedema, rash, pruritus) Pediatric use information is approved for Cubist Pharmaceuticals LLC's DIFICID ® (fidaxomicin) tablets.

However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that information.

🔄 Drug Interactions 120 words ▾

7 DRUG INTERACTIONS Fidaxomicin and its main metabolite, OP-1118, are substrates of the efflux transporter, P-glycoprotein (P-gp), which is expressed in the gastrointestinal tract.

7.1Cyclosporine Cyclosporine is an inhibitor of multiple transporters, including P-gp. When cyclosporine was co-administered with fidaxomicin, plasma concentrations of fidaxomicin and OP-1118 were significantly increased but remained in the ng/mL range [see Clinical Pharmacology (12.3)] . Concentrations of fidaxomicin and OP-1118 may also be decreased at the site of action (i.e., gastrointestinal tract) via P-gp inhibition; however, concomitant P-gp inhibitor use had no attributable effect on safety or treatment outcome of fidaxomicin-treated adult patients in controlled clinical trials.

Based on these results, fidaxomicin may be co-administered with P-gp inhibitors and no dose adjustment is recommended.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pediatrics: The safety and effectiveness of fidaxomicin tablets have not been established in pediatric patients younger than 6 months of age. ( 8.4 ) Pediatric use information is approved for Cubist Pharmaceuticals LLC's DIFICID ® (fidaxomicin) tablets. However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that information.

8.1Pregnancy Risk Summary The limited available data on use of fidaxomicin tablets in pregnant women are insufficient to inform any drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. Embryo-fetal reproduction studies in rats and rabbits dosed intravenously during organogenesis revealed no evidence of harm to the fetus at fidaxomicin and OP-1118 (its main metabolite) exposures 65-fold or higher than the clinical exposure at the fidaxomicin tablets recommended dose [see Data] .

The estimated background risk of major birth defects and miscarriage for the indicated populations 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.

Data Animal Data In pregnant rats, fidaxomicin was administered intravenously at doses of 4, 8, and 15 mg/kg/day from gestation day 6 through 17 (during the period of organogenesis). No embryo/fetal effects were noted in this study at exposures (AUC) 193-fold higher for fidaxomicin, and 65-fold higher for OP-1118 than the clinical exposure at the fidaxomicin tablets recommended dose. In pregnant rabbits, fidaxomicin was administered intravenously at doses of 2, 4, and 7.5 mg/kg/day from gestation day 6 through 18 (during the period of organogenesis).

No embryo/fetal effects were noted in this study at exposures 66-fold higher for fidaxomicin, and 245-fold higher for OP-1118 than the clinical exposure at the fidaxomicin tablets recommended dose.

8.2Lactation Risk Summary There is no information on the presence of fidaxomicin or its main metabolite, OP-1118, in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fidaxomicin tablets and any potential adverse effects on the breastfed infant from fidaxomicin tablets or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of fidaxomicin tablets have not been established in pediatric patients younger than 6 months of age. Pediatric use information is approved for Cubist Pharmaceuticals LLC's DIFICID ® (fidaxomicin) tablets. However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that information.

8.5Geriatric Use Of the total number of patients in controlled trials of fidaxomicin tablets, 50% were 65 years of age and over, while 31% were 75 and over. No overall differences in safety or effectiveness of fidaxomicin tablets compared to vancomycin were observed between these subjects and younger subjects. In controlled trials, elderly patients (≥65 years of age) had higher plasma concentrations of fidaxomicin and its main metabolite, OP-1118, versus non-elderly patients (<65 years of age) [see Clinical Pharmacology (12.3)] .

However, greater exposures in elderly patients were not considered to be clinically significant. No dose adjustment is recommended for elderly patients.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary The limited available data on use of fidaxomicin tablets in pregnant women are insufficient to inform any drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. Embryo-fetal reproduction studies in rats and rabbits dosed intravenously during organogenesis revealed no evidence of harm to the fetus at fidaxomicin and OP-1118 (its main metabolite) exposures 65-fold or higher than the clinical exposure at the fidaxomicin tablets recommended dose [see Data] .

The estimated background risk of major birth defects and miscarriage for the indicated populations 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.

Data Animal Data In pregnant rats, fidaxomicin was administered intravenously at doses of 4, 8, and 15 mg/kg/day from gestation day 6 through 17 (during the period of organogenesis). No embryo/fetal effects were noted in this study at exposures (AUC) 193-fold higher for fidaxomicin, and 65-fold higher for OP-1118 than the clinical exposure at the fidaxomicin tablets recommended dose. In pregnant rabbits, fidaxomicin was administered intravenously at doses of 2, 4, and 7.5 mg/kg/day from gestation day 6 through 18 (during the period of organogenesis).

No embryo/fetal effects were noted in this study at exposures 66-fold higher for fidaxomicin, and 245-fold higher for OP-1118 than the clinical exposure at the fidaxomicin tablets recommended dose.

🧒 Pediatric Use 54 words ▾

8.4Pediatric Use The safety and effectiveness of fidaxomicin tablets have not been established in pediatric patients younger than 6 months of age. Pediatric use information is approved for Cubist Pharmaceuticals LLC's DIFICID ® (fidaxomicin) tablets. However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that information.

🧓 Geriatric Use 103 words ▾

8.5Geriatric Use Of the total number of patients in controlled trials of fidaxomicin tablets, 50% were 65 years of age and over, while 31% were 75 and over. No overall differences in safety or effectiveness of fidaxomicin tablets compared to vancomycin were observed between these subjects and younger subjects. In controlled trials, elderly patients (≥65 years of age) had higher plasma concentrations of fidaxomicin and its main metabolite, OP-1118, versus non-elderly patients (<65 years of age) [see Clinical Pharmacology (12.3)] .

However, greater exposures in elderly patients were not considered to be clinically significant. No dose adjustment is recommended for elderly patients.

🆘 Overdosage 39 words ▾

10 OVERDOSAGE No cases of acute overdose have been reported in humans. No drug-related adverse effects were seen in dogs dosed with fidaxomicin tablets at 9,600 mg/day (over 100 times the human dose, scaled by weight) for 3 months.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

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

12.2Pharmacodynamics Fidaxomicin acts locally in the gastrointestinal tract on C. difficile . In a dose-ranging trial (N=48) of fidaxomicin using 50 mg, 100 mg, and 200 mg twice daily for 10 days, a dose-response relationship was observed for efficacy.

12.3Pharmacokinetics The pharmacokinetic parameters of fidaxomicin and its main metabolite OP-1118 following a single dose of 200 mg in healthy adult males (N=14) are summarized in Table 4. Table 4: Mean (± Standard Deviation) Pharmacokinetic Parameters of Fidaxomicin 200 mg in Healthy Adult Males Parameter Fidaxomicin OP- 1118 N Value N Value C max (ng/mL) 14 5.20 ± 2.81 14 12.0 ±

6.06T max (h)* 14 2.00 (1.00 to 5.00) 14 1.02 (1.00 to 5.00) AUC 0 to t (ng-h/mL) 14 48.3 ± 18.4 14 103 ±

39.4AUC 0 to ∞ (ng-h/mL) 9 62.9 ± 19.5 10 118 ± 43.3 t 1/2 (h) 9 11.7 ± 4.80 10 11.2 ± 3.01 * T max , reported as median (range). C max , maximum observed concentration; T max , time to maximum observed concentration; AUC 0 to t , area under the concentration-time curve from time 0 to the last measured concentration; AUC 0 to ∞ , area under the concentration-time curve from time 0 to infinity; t 1/2 , elimination half-life Absorption Fidaxomicin has minimal systemic absorption following oral administration, with plasma concentrations of fidaxomicin and OP-1118 in the ng/mL range at the therapeutic dose.

In fidaxomicin-treated patients from controlled trials, plasma concentrations of fidaxomicin and OP-1118 obtained within the T max window (1 to 5 hours) were approximately 2- to 6-fold higher than C max values in healthy adults. Following administration of fidaxomicin tablets 200 mg twice daily for 10 days, OP-1118 plasma concentrations within the Tmax window were approximately 50% to 80% higher than on Day 1, while concentrations of fidaxomicin were similar on Days 1 and 10. In a food-effect study involving administration of fidaxomicin tablets to healthy adults (N=28) with a high-fat meal versus under fasting conditions, C max of fidaxomicin and OP-1118 decreased by 21.5% and 33.4%, respectively, while AUC 0 to t remained unchanged.

This decrease in C max is not considered clinically significant, and thus, fidaxomicin tablets may be administered with or without food. Distribution Fidaxomicin is mainly confined to the gastrointestinal tract following oral administration. In selected patients (N=8) treated with fidaxomicin tablets 200 mg twice daily for 10 days from controlled trials, fecal concentrations of fidaxomicin and OP-1118 obtained within 24 hours of the last dose ranged from 639 to 2,710 mcg /g and 213 to 1,210 mcg /g, respectively.

In contrast, plasma concentrations of fidaxomicin and OP-1118 within the T max window (1 to 5 hours) ranged 2 to 179 ng/mL and 10 to 829 ng/mL, respectively. Elimination Metabolism Fidaxomicin is primarily transformed by hydrolysis at the isobutyryl ester to form its main and microbiologically active metabolite, OP-1118. Metabolism of fidaxomicin and formation of OP-1118 are not dependent on cytochrome P450 (CYP) enzymes.

At the therapeutic dose, OP-1118 was the predominant circulating compound in healthy adults, followed by fidaxomicin. Excretion Fidaxomicin is mainly excreted in feces. In one trial of healthy adults (N=11), more than 92% of the dose was recovered in the stool as fidaxomicin and OP-1118 following single doses of 200 mg and 300 mg.

In another trial of healthy adults (N=6), 0.59% of the dose was recovered in urine as OP-1118 only following a single dose of 200 mg. Specific Populations Geriatric Patients In controlled trials of patients treated with fidaxomicin tablets 200 mg twice daily for 10 days, mean and median values of fidaxomicin and OP-1118 plasma concentrations within the Tmax window (1 to 5 hours) were approximately 2- to 4-fold higher in elderly patients (≥65 years of age) versus non-elderly patients (<65 years of ag… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 75 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Fidaxomicin tablets are white to off white, capsule shaped, film coated tablets debossed with '2F' on one side and plain on the other side. Fidaxomicin tablets are supplied as HDPE bottles of 20 tablets (NDC 13668-745-21).

16.2Storage Store fidaxomicin tablets at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). See USP controlled room temperature. Store in the original bottle.

📋 Description 98 words ▾

11 DESCRIPTION Fidaxomicin is a macrolide antibacterial drug for oral administration. Its CAS chemical name is Oxacyclooctadeca-3,5,9,13,15-pentaen-2-one,3-[[[6-deoxy-4- O -(3,5-dichloro-2-ethyl-4,6-dihydroxybenzoyl)-2- O -methyl-β-D-mannopyranosyl]oxy]methyl]-12-[[6-deoxy-5-C-methyl-4- O -(2-methyl-1-oxopropyl)-β-D- lyxo -hexopyranosyl]oxy]-11-ethyl-8-hydroxy-18-[(1 R )-1-hydroxyethyl]-9,13,15-trimethyl-, (3 E ,5 E ,8 S ,9 E ,11 S ,12 R ,13 E ,15 E ,18 S )-. The structural formula of fidaxomicin is shown in Figure 1.

Fidaxomicin tablets are film-coated and contain 200 mg of fidaxomicin per tablet and the following inactive ingredients: butylated hydroxyl toluene, hydroxypropyl cellulose, lecithin (soya), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide. figure-1

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Clinical Studies of Fidaxomicin Tablets in Adult Patients with CDAD In two randomized, double-blinded trials, a non-inferiority design was utilized to demonstrate the efficacy of fidaxomicin tablets (200 mg tablets twice daily for 10 days) compared to vancomycin (125 mg four times daily for 10 days) in adults with CDAD. Enrolled patients were 18 years of age or older and received no more than 24 hours of pretreatment with vancomycin or metronidazole. CDAD was defined by >3 unformed bowel movements (or >200 mL of unformed stool for subjects having rectal collection devices) in the 24 hours before randomization, and presence of either C. difficile toxin A or B in the stool within 48 hours of randomization.

Enrolled patients had either no prior CDAD history or only one prior CDAD episode in the past three months. Subjects with life-threatening/fulminant infection, hypotension, septic shock, peritoneal signs, significant dehydration, or toxic megacolon were excluded. The demographic profile and baseline CDAD characteristics of enrolled subjects were similar in the two trials.

Patients had a median age of 64 years, were mainly white (90%), female (58%), and inpatients (63%). The median number of bowel movements per day was 6, and 37% of subjects had severe CDAD (defined as 10 or more unformed bowel movements per day or WBC ≥15,000/mm 3 ). Diarrhea alone was reported in 45% of patients and 84% of subjects had no prior CDAD episode.

The primary efficacy endpoint was the clinical response rate at the end of treatment, based upon improvement in diarrhea or other symptoms such that, in the investigator's judgment, further CDAD treatment was not needed. An additional efficacy endpoint was sustained clinical response 25 days after the end of treatment. Sustained response was evaluated only for patients who were clinical successes at the end of treatment.

Sustained response was defined as clinical response at the end of treatment, and survival without proven or suspected CDAD recurrence through 25 days beyond the end of treatment. The results for clinical response at the end of treatment in both trials, shown in Table 6, indicate that fidaxomicin tablets are non-inferior to vancomycin based on the 95% confidence interval (CI) lower limit being greater than the non-inferiority margin of -10%. The results for sustained clinical response at the end of the follow-up period, also shown in Table 6, indicate that fidaxomicin tablets are superior to vancomycin on this endpoint.

Since clinical success at the end of treatment and mortality rates were similar across treatment arms (approximately 6% in each group), differences in sustained clinical response were due to lower rates of proven or suspected CDAD during the follow-up period in fidaxomicin tablets patients. Table 6: Clinical Response Rates at End-of-Treatment and Sustained Response at 25 days Post-Treatment in Adult Patients Clinical Response at End of Treatment Sustained Response at 25 days Post-Treatment Fidaxomicin Tablets % (N) Vancomycin % (N) Difference (95% CI)* Fidaxomicin Tablets % (N) Vancomycin % (N) Difference (95% CI)* Trial 1 88% (N=289) 86% (N=307) 2.6% (-2.9%, 8.0%) 70% (N=289) 57% (N=307) 12.7% (4.4%, 20.9%) Trial 2 88% (N=253) 87% (N=256) 1.0% (-4.8%, 6.8%) 72% (N=253) 57% (N=256) 14.6% (5.8%, 23.3%) * Confidence interval (CI) was derived using Wilson's score method.

Approximately 5% to 9% of the data in each trial and treatment arm were missing sustained response information and were imputed using multiple imputation method. Restriction Endonuclease Analysis (REA) was used to identify C. difficile baseline isolates in the BI group, isolates associated with increasing rates and severity of CDAD in the US in the years prior to the clinical trials. Similar rates of clinical response at the end of treatment and proven or suspected CDAD during the follow-up period were seen in fidaxomicin-treated and vancomycin-treated patients infected with a BI isola… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 82 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies have not been conducted to evaluate the carcinogenic potential of fidaxomicin. Neither fidaxomicin nor OP-1118 was mutagenic in the Ames assay. Fidaxomicin was also negative in the rat micronucleus assay.

However, fidaxomicin was clastogenic in Chinese hamster ovary cells. Fidaxomicin did not affect the fertility of male and female rats at intravenous doses of 6.3 mg/kg. The exposure (AUC 0 to t ) was approximately 100 times that in humans.

📄 Patient Package Insert ~3 min read ▾

Patient Information Fidaxomicin (fye dax" oh mye' sin) tablets, for oral use What You Need to Know About Your Medicine Before you take fidaxomicin tablets, be sure you understand what it is for and how to take it. If you have questions about fidaxomicin tablets, ask your doctor or pharmacist. Remember that your doctor has prescribed fidaxomicin tablets only for you.

Never give this medicine to anyone else. Keep this Patient Information for fidaxomicin tablets so you can read it again. What is fidaxomicin tablets?

Fidaxomicin tablet is an antibiotic medicine used to treat an infection called Clostridioides difficile -associated diarrhea (CDAD) in adults. Clostridioides difficile (C-diff) is a bacterium that can cause an infection that can damage your colon and cause stomach pain and severe diarrhea. Fidaxomicin tablet is not to be used to treat other types of infections in the body.

Sometimes infections are caused by viruses rather than bacteria. Antibiotic medicines, including fidaxomicin tablets, do not kill viruses. It is not known if fidaxomicin tablets are safe and effective in children under 6 months old.

Who should not take fidaxomicin tablets? Do not take fidaxomicin tablets if you are allergic to fidaxomicin, or any other ingredient in fidaxomicin tablets. See the end of this Patient Information for a complete list of ingredients in fidaxomicin tablets.

What should I tell my doctor before taking fidaxomicin tablets? Pregnancy If you are pregnant or plan to become pregnant, tell your doctor before you take fidaxomicin tablets. It is not known if fidaxomicin tablets will harm your baby while you are pregnant.

If you are pregnant, you and your doctor should decide together if you will take fidaxomicin tablets. Breastfeeding If you are breastfeeding or plan to breastfeed, tell your doctor before you take fidaxomicin tablets. It is not known if fidaxomicin passes into breast milk.

If you are breastfeeding, you and your doctor should decide together if you will take fidaxomicin tablets. Other Medicines Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal and dietary supplements. Know the medicines you take.

Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine. Allergic Reactions See “ Who should not take fidaxomicin tablets ?” If you are allergic to other kinds of antibiotics called macrolides (for example: azithromycin (Zithromax) or clarithromycin (Biaxin)) or any other ingredient in fidaxomicin tablets, tell your doctor. See the end of this Patient Information for a complete list of ingredients in fidaxomicin tablets.

How do I take fidaxomicin tablets? Take fidaxomicin tablets exactly as prescribed by your doctor. Take fidaxomicin tablets twice a day (approximately every 12 hours).

For example, if you take your first dose at 8:00 a.m. you should take your second dose at 8:00 p.m. You can take fidaxomicin tablets with or without food. Do not skip any doses or stop taking fidaxomicin tablets until you finish your prescribed treatment, even if you begin to feel better, unless you have a serious allergic reaction (see “ What are the possible side effects of fidaxomicin tablets? ”).

This will lower the chance that the bacteria will become resistant to fidaxomicin tablets. If this happens, fidaxomicin tablets and other antibiotic medicines may not work in the future. What are the possible side effects of fidaxomicin tablets?

Fidaxomicin tablets can cause serious side effects, including : Allergic reaction . If you get a severe allergic reaction while taking fidaxomicin tablets, including problems breathing or shortness of breath, rash, itching or hives, or swelling of the mouth, throat, or face, stop taking fidaxomicin tablets and get emergency medical help right away. Common side effects of fidaxomicin tablets include: The most common side effects of fidaxomicin tablets in adults include: nausea bleeding in the… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 6 words ▾

Fidaxomicin Tablets - 20 tablets container

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

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

Medicare Part D (outpatient prescription) spending for Fidaxomicin — the program that covers self-administered drugs. 3 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 Fidaxomicin. 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
$26.78M
Claims incl. refills
8.3K
Beneficiaries
7K
Spend / beneficiary
$3,800.21
Spend / claim
$3,222.57
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.
← 13668-0737-30 · Torrent 13668-0746-05 · Torrent →
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.