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Ribavirin 200 mg Tablet, Film Coated, 3,000-count — NDC 65862-0207-39 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ribavirin 200 mg Tablet, Film Coated, 3,000-count — NDC 65862-207-39 (Billing 65862-0207-39)

by Aurobindo Pharma Limited · 3000 TABLET, FILM COATED in 1 BAG

This is a package of 3,000 tablets of Ribavirin 200 mg Tablet, Film Coated from Aurobindo Pharma Limited, marketed since Sep 2009 and currently FDA-listed.

NDC 65862-0207-39
🏷️ FDA NDC (as labeled) 65862-207-39 billing pads the product segment with a zero
This package
Contains3,000-count Pack sizes3 compare ↓
Product page 65862-0207-68 Also comes in: 168 tablets 65862-207-68 500 tablets 65862-207-05
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 →

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) 65862-207-39
Product NDC 65862-207
11-digit billing NDC 65862020739
RxCUI 248109
UNII 49717AWG6K
Application # ANDA079111
SPL Set ID eee304d0-c2ea-44f4-97d9-92a414d31b6c
Established class (EPC) Nucleoside Analog Antiviral
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-09-17
Route ORAL
Dosage form TABLET, FILM COATED
Substance RIBAVIRIN
TE code (Orange Book) AB · RLD · RS

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

GPI-14 12353070000320
GPI class Ribavirin
GCN Seq No 051637
GCN 18969
HICL code 004184
Ingredient (HICL) Ribavirin
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W5
Therapeutic class — intermediate (HIC2) Antiviral Agents
HIC3 code W5G
Therapeutic class — specific (HIC3) Hepatitis C Treatment Agents
AHFS code 08:18.32.00
AHFS class Nucleoside And Nucleotide Antivirals
FDB label name RIBAVIRIN 200 MG TABLET
FDB brand name Ribavirin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 051637
  • GCN: 18969
  • GPI-14 (Medi-Span): 12353070000320
  • HICL (First Databank): 004184
  • AHFS class code: 08:18.32.00
  • RxCUI (RxNorm): 248109
Why two NDCs? The FDA registers this code as 65862-207-39 — 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 → 65862-0207-39. 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 Nucleoside Analog Antiviral class.

Pharmacologic class Nucleoside Analog Antiviral
Drug family (ATC) Antivirals for treatment of HCV infections
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 RIBAVIRIN 200 MG TABLET Ingredient Ribavirin
📖 What it is MedlinePlus · NLM

Ribavirin is used with an interferon medication such as peginterferon alfa-2a [Pegasys] or peginterferon alpha-2b [PEG-Intron]) to treat hepatitis C in people who have not been treated with an interferon before. Ribavirin is in a class of antiviral medications called nucleoside analogues. It works by stopping the virus that causes hepatitis C from spreading inside the body. It is not known if treatment that includes ribavirin and another medication cures hepatitis C infection, prevents liver damage that may be caused by hepatitis C, or prevents the spread of hepatitis C to other people.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the form. Tablets and capsules are used with an interferon medicine to treat chronic hepatitis C. The inhaled form is used in hospitals for severe RSV lung infections...
  • Take them by mouth with food, usually split into two doses a day, as your prescriber directs. Don't open, crush or break the capsules. Keep taking your interferon medicine as presc...
  • How should I take my ribavirin tablets or capsules?
  • Tiredness, headache, fever and chills, nausea, muscle aches, trouble sleeping and mood changes are common. Many of these come partly from the interferon it's paired with. Call us i...
📖 Read our full Ribavirin guide →
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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 168 tablets 500 tablets
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 Per unit Per pack Marketing startMarketing endStatus
65862-0207-05 65862-207-05 500 TABLET, FILM COATED in 1 BOTTLE — — 2009-09-17 — Active
65862-0207-68 65862-207-68 Main listing 168 TABLET, FILM COATED in 1 BOTTLE $0.4507 / ea $75.72 2009-09-17 — Active
65862-0207-39 You're viewing this 3000 TABLET, FILM COATED in 1 BAG — — — — Active

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

This pack shows little to no recent Medicaid volume — the 168 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 3,000-count package — 3000 tablet, film coated in 1 bag.
How does this package differ from NDC 65862-0207-68?
Both are Ribavirin 200 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 3,000-count one, while NDC 65862-0207-68 is the 168 tablets package.
What NDC number is used to bill for this package of Ribavirin 200 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ribavirin 200 mgthis 65862-0207-39 Aurobindo 3000 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

🏛️
2009
On the market since
Sep 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

What it looks like

Color Pink
ShapeCapsule
ImprintF;10
Size13 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 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 36SFW2JZ0W
    Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into 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 U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • 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 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.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

12 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

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA079111 (ANDA)
Labeler code65862
First marketedSep 2009
Product typeHuman Prescription Drug
Portfolio1,456 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.
🚨 Boxed Warning 🎯 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 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRIN-ASSOCIATED EFFECTS Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication. The primary clinical toxicity of ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease and lead to fatal and nonfatal myocardial infarctions.

Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin [see Warnings and Precautions (5.2) , Adverse Reactions (6.1) , and Dosage and Administration (2.3) ] . Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple dose half-life of 12 days, and it may persist in non-plasma compartments for as long as 6 months.

Therefore, ribavirin, including ribavirin tablets, are contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of therapy in both female patients and in female partners of male patients who are taking ribavirin therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month post treatment follow-up period [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1) ] .

WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRIN­-ASSOCIATED EFFECTS See full prescribing information for complete boxed warning. Ribavirin monotherapy, including ribavirin, is not effective for the treatment of chronic hepatitis C virus infection ( Boxed Warning ). The hemolytic anemia associated with ribavirin therapy may result in worsening of cardiac disease and lead to fatal and nonfatal myocardial infarctions.

Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin (2.3 , 5.2 , 6.1) . Significant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Therefore, ribavirin is contraindicated in women who are pregnant and in the male partners of women who are pregnant.

Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking ribavirin therapy (4 , 5.1 , 8.1) .

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Ribavirin tablets in combination with PEGASYS ® (peginterferon alfa-2a) are indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha. The following points should be considered when initiating ribavirin tablets combination therapy with PEGASYS ® : This indication is based on clinical trials of combination therapy in patients with CHC and compensated liver disease, some of whom had histological evidence of cirrhosis (Child-Pugh class A), and in adult patients with clinically stable HIV disease and CD4 count greater than 100 cells/mm 3 .

This indication is based on achieving undetectable HCV RNA after treatment for 24 or 48 weeks, based on HCV genotype, and maintaining a Sustained Virologic Response (SVR) 24 weeks after the last dose. Safety and efficacy data are not available for treatment longer than 48 weeks. The safety and efficacy of ribavirin tablets and PEGASYS ® therapy have not been established in liver or other organ transplant recipients, patients with decompensated liver disease, or previous non-responders to interferon therapy.

The safety and efficacy of ribavirin tablets therapy for the treatment of adenovirus, RSV, parainfluenza or influenza infections have not been established. Ribavirin tablets should not be used for these indications. Ribavirin for inhalation has a separate package insert, which should be consulted if ribavirin inhalation therapy is being considered.

Ribavirin tablets are a nucleoside analogue indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with PEGASYS ® in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha, and in adult CHC patients coinfected with HIV (1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Ribavirin tablets should be taken with food. Ribavirin tablets should be given in combination with PEGASYS ® ; it is important to note that ribavirin tablets should never be given as monotherapy. See PEGASYS ® Package Insert for all instructions regarding PEGASYS ® dosing and administration.

CHC: Ribavirin tablets are administered according to body weight and genotype (2.1) CHC with HIV coinfection: 800 mg by mouth daily for a total of 48 weeks, regardless of genotype (2.2) Dose reduction or discontinuation is recommended in patients experiencing certain adverse reactions or renal impairment (2.3 , 2.4)

2.1Chronic Hepatitis C Monoinfection Adult Patients The recommended dose of ribavirin tablets is provided in Table 1 . The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks. The daily dose of ribavirin tablets is 800 mg to 1200 mg administered orally in two divided doses.

The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen (see Table 1 ). Table 1 PEGASYS ® and Ribavirin Tablets Dosing Recommendations Genotypes 2 and 3 showed no increased response to treatment beyond 24 weeks (see Table 10 ). Data on genotypes 5 and 6 are insufficient for dosing recommendations. * See PEGASYS ® Package Insert for further details on PEGASYS ® dosing and administration, including dose modification in patients with renal impairment.

Hepatitis C Virus (HCV) Genotype PEGASYS ® Dose* (once weekly) Ribavirin Tablets Dose (daily) Duration Genotypes 1, 4 180 mcg <75 kg = 1000 mg ≥75 kg = 1200 mg 48 weeks 48 weeks Genotypes 2, 3 180 mcg 800 mg 24 weeks Pediatric Patients PEGASYS ® is administered as 180 mcg/1.73m 2 x BSA once weekly subcutaneously, to a maximum dose of 180 mcg, and should be given in combination with ribavirin. The recommended treatment duration for patients with genotype 2 or 3 is 24 weeks and for other genotypes is 48 weeks. Ribavirin tablets should be given in combination with PEGASYS ® .

Ribavirin tablets are available only as a 200 mg tablet and therefore the healthcare provider should determine if this sized tablet can be swallowed by the pediatric patient. The recommended doses for ribavirin tablets are provided in Table 2 . Patients who initiate treatment prior to their 18 th birthday should maintain pediatric dosing through the completion of therapy.

Table 2 Ribavirin Tablets Dosing Recommendations for Pediatric Patients *approximately 15 mg/kg/day Body Weight in kilograms (kg) Ribavirin Tablets Daily Dose* Ribavirin Tablets Number of Tablets 23 to 33 400 mg/day 1 x 200 mg tablet A.M. 1 x 200 mg tablet P.M. 34 to 46 600 mg/day 1 x 200 mg tablet A.M.

2 x 200 mg tablets P.M. 47 to 59 800 mg/day 2 x 200 mg tablets A.M. 2 x 200 mg tablets P.M.

60 to 74 1000 mg/day 2 x 200 mg tablets A.M. 3 x 200 mg tablets P.M. ≥75 1200 mg/day 3 x 200 mg tablets A.M. 3 x 200 mg tablets P.M.

2.2Chronic Hepatitis C with HIV Coinfection Adult Patients The recommended dose for treatment of chronic hepatitis C in patients coinfected with HIV is PEGASYS ® 180 mcg subcutaneous once weekly and ribavirin tablets 800 mg by mouth daily for a total duration of 48 weeks, regardless of HCV genotype.

2.3Dose Modifications Adult and Pediatric Patients If severe adverse reactions or laboratory abnormalities develop during combination ribavirin tablets/PEGASYS ® therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after dose adjustment, ribavirin tablets/PEGASYS ® therapy should be discontinued. Table 3 provides guidelines for dose modifications and discontinuation based on the patient’s hemoglobin concentration and cardiac status.

Ribavirin tablets should be administered with caution to patients with pre-existing cardiac disease. Patients should be assessed befo… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 33 words ▾

3 DOSAGE FORMS AND STRENGTHS Ribavirin is available as a light pink colored, capsule shaped, film-coated tablet for oral administration. Each tablet contains 200 mg of ribavirin. Ribavirin tablets, USP 200 mg (3)

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS Ribavirin tablets are contraindicated in: Women who are pregnant. Ribavirin tablets may cause fetal harm when administered to a pregnant woman. Ribavirin tablets are contraindicated in women who are or may become pregnant.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1) , and Patient Counseling Information (17) ] . Men whose female partners are pregnant. Patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia).

In combination with didanosine. Reports of fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials [see Drug Interactions (7.1) ] . Ribavirin tablets and PEGASYS ® combination therapy are contraindicated in patients with: Autoimmune hepatitis.

Hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before treatment [see Warnings and Precautions (5.3) ] . Hepatic decompensation (Child-Pugh score greater than or equal to 6) in cirrhotic CHC patients coinfected with HIV before treatment [see Warnings and Precautions (5.3) ] . Pregnant women and men whose female partners are pregnant (4 , 5.1 , 8.1 ) Hemoglobinopathies (4) Coadministration with didanosine (4 , 7.1) Ribavirin tablets in combination with PEGASYS ® are contraindicated in patients with: Autoimmune hepatitis (4) Hepatic decompensation in cirrhotic patients (4 , 5.3)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Significant adverse reactions associated with ribavirin/PEGASYS ® combination therapy include severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, ophthalmologic disorders, cerebrovascular disorders, pulmonary dysfunction, colitis, pancreatitis, and diabetes. The PEGASYS ® Package Insert should be reviewed in its entirety for additional safety information prior to initiation of combination treatment. Birth defects and fetal death with ribavirin: Do not use in pregnancy and for 6 months after treatment.

Patients must have a negative pregnancy test prior to therapy, use at least 2 forms of contraception and undergo monthly pregnancy tests (4 , 5.1 , 8.1) PEGASYS ® /Ribavirin: Patients exhibiting the following conditions should be closely monitored and may require dose reduction or discontinuation of therapy: Hemolytic anemia may occur with a significant initial drop in hemoglobin. This may result in worsening cardiac disease leading to fatal or nonfatal myocardial infarctions (5.2 , 6.1) Risk of hepatic failure and death: Monitor hepatic function during treatment and discontinue treatment for hepatic decompensation (5.3) Severe hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, and anaphylaxis, and serious skin reactions such as Stevens-Johnson syndrome (5.4) Pulmonary disorders, including pulmonary function impairment and pneumonitis, including fatal cases of pneumonia (5.5) Severe depression and suicidal ideation, autoimmune and infectious disorders, suppression of bone marrow function, pancreatitis, and diabetes (5) Bone marrow suppression with azathioprine coadministration (5.6) Growth impairment with combination therapy in pediatric patients (5.8)

5.1Pregnancy Ribavirin may cause birth defects and/or death of the exposed fetus. Ribavirin has demonstrated significant teratogenic and/or embryocidal effects in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of ribavirin.

Ribavirin therapy should not be started unless a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Patients should be instructed to use at least two forms of effective contraception during treatment and for 6 months after treatment has been stopped.

Pregnancy testing should occur monthly during ribavirin therapy and for 6 months after therapy has stopped [see Boxed Warning , Contraindications (4) , Use in Specific Populations (8.1) , and Patient Counseling Information (17) ].

5.2Anemia The primary toxicity of ribavirin is hemolytic anemia, which was observed in approximately 13% of all ribavirin/PEGASYS ® -treated subjects in clinical trials. Anemia associated with ribavirin occurs within 1 to 2 weeks of initiation of therapy. Because the initial drop in hemoglobin may be significant, it is advised that hemoglobin or hematocrit be obtained pretreatment and at week 2 and week 4 of therapy or more frequently if clinically indicated.

Patients should then be followed as clinically appropriate. Caution should be exercised in initiating treatment in any patient with baseline risk of severe anemia (e.g., spherocytosis, history of gastrointestinal bleeding) [see Dosage and Administration (2.3) ] . Fatal and nonfatal myocardial infarctions have been reported in patients with anemia caused by ribavirin.

Patients should be assessed for underlying cardiac disease before initiation of ribavirin therapy. Patients with pre-existing cardiac disease should have electrocardiograms administered before treatment, and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be suspended or discontinued [see Dosage and Ad… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS PEGASYS ® in combination with ribavirin causes a broad variety of serious adverse reactions [see Boxed Warning and Warnings and Precautions (5) ] . The most common serious or life-threatening adverse reactions induced or aggravated by ribavirin/PEGASYS ® include depression, suicide, relapse of drug abuse/overdose, and bacterial infections each occurring at a frequency of less than 1%. Hepatic decompensation occurred in 2% (10/574) CHC/HIV patients [see Warnings and Precautions (5.3) ] .

The most common adverse reactions (frequency greater than 40%) in adults receiving combination therapy are fatigue/asthenia, pyrexia, myalgia, and headache. (6.1) The most common adverse reactions in pediatric subjects were similar to those seen in adults. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies 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 clinical practice. Adult Patients In the pivotal registration trials NV15801 and NV15942, 886 patients received ribavirin for 48 weeks at doses of 1000/1200 mg based on body weight. In these trials, one or more serious adverse reactions occurred in 10% of CHC monoinfected subjects and in 19% of CHC/HIV subjects receiving PEGASYS ® alone or in combination with ribavirin.

The most common serious adverse event (3% in CHC and 5% in CHC/HIV) was bacterial infection (e.g., sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia). Other serious adverse reactions occurred at a frequency of less than 1% and included: suicide, suicidal ideation, psychosis, aggression, anxiety, drug abuse and drug overdose, angina, hepatic dysfunction, fatty liver, cholangitis, arrhythmia, diabetes mellitus, autoimmune phenomena (e.g., hyperthyroidism, hypothyroidism, sarcoidosis, systemic lupus erythematosus, rheumatoid arthritis), peripheral neuropathy, aplastic anemia, peptic ulcer, gastrointestinal bleeding, pancreatitis, colitis, corneal ulcer, pulmonary embolism, coma, myositis, cerebral hemorrhage, thrombotic thrombocytopenic purpura, psychotic disorder, and hallucination.

The percentage of patients in clinical trials who experienced one or more adverse events was 98%. The most commonly reported adverse reactions were psychiatric reactions, including depression, insomnia, irritability, anxiety, and flu-like symptoms such as fatigue, pyrexia, myalgia, headache and rigors. Other common reactions were anorexia, nausea and vomiting, diarrhea, arthralgias, injection site reactions, alopecia, and pruritus.

Table 5 shows rates of adverse events occurring in greater than or equal to 5% of subjects receiving pegylated interferon and ribavirin combination therapy in the CHC Clinical Trial, NV15801. Ten percent of CHC monoinfected patients receiving 48 weeks of therapy with PEGASYS ® in combination with ribavirin discontinued therapy; 16% of CHC/HIV coinfected patients discontinued therapy. The most common reasons for discontinuation of therapy were psychiatric, flu-like syndrome (e.g., lethargy, fatigue, headache), dermatologic and gastrointestinal disorders, and laboratory abnormalities (thrombocytopenia, neutropenia, and anemia).

Overall 39% of patients with CHC or CHC/HIV required modification of PEGASYS ® and/or ribavirin therapy. The most common reason for dose modification of PEGASYS ® in CHC and CHC/HIV patients was for laboratory abnormalities; neutropenia (20% and 27%, respectively) and thrombocytopenia (4% and 6%, respectively). The most common reason for dose modification of ribavirin in CHC and CHC/HIV patients was anemia (22% and 16%, respectively).

PEGASYS ® dose was reduced in 12% of patients receiving 1000 mg to 1200 mg ribavirin for 48 weeks and in 7% of… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Results from a pharmacokinetic sub-study demonstrated no pharmacokinetic interaction between PEGASYS ® (peginterferon alfa-2a) and ribavirin. Nucleoside analogues: Closely monitor for toxicities. Discontinue nucleoside reverse transcriptase inhibitors or reduce dose or discontinue interferon, ribavirin or both with worsening toxicities (7.1) Azathioprine: Concomitant use of azathioprine with ribavirin has been reported to induce severe pancytopenia and may increase the risk of azathioprine-related myelotoxicity (7.3)

7.1Nucleoside Reverse Transcriptase Inhibitors (NRTIs) In vitro data indicate ribavirin reduces phosphorylation of lamivudine, stavudine, and zidovudine. However, no pharmacokinetic (e.g., plasma concentrations or intracellular triphosphorylated active metabolite concentrations) or pharmacodynamic (e.g., loss of HIV/HCV virologic suppression) interaction was observed when ribavirin and lamivudine (n=18), stavudine (n=10), or zidovudine (n=6) were coadministered as part of a multi-drug regimen to HCV/HIV coinfected patients.

In Study NR15961 among the CHC/HIV coinfected cirrhotic patients receiving NRTIs, cases of hepatic decompensation (some fatal) were observed [see Warnings and Precautions (5.3) ] . Patients receiving PEGASYS ® /ribavirin and NRTIs should be closely monitored for treatment-associated toxicities. Physicians should refer to prescribing information for the respective NRTIs for guidance regarding toxicity management.

In addition, dose reduction or discontinuation of PEGASYS ® , ribavirin or both should also be considered if worsening toxicities are observed, including hepatic decompensation (e.g., Child-Pugh greater than or equal to 6) [see Warnings and Precautions (5.3) and Dosage and Administration (2.3) ] . Didanosine Coadministration of ribavirin and didanosine is contraindicated. Didanosine or its active metabolite (dideoxyadenosine 5’-triphosphate) concentrations are increased when didanosine is coadministered with ribavirin, which could cause or worsen clinical toxicities.

Reports of fatal hepatic failure as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials [see Contraindications (4) ] . Zidovudine In Study NR15961, patients who were administered zidovudine in combination with PEGASYS ® /ribavirin developed severe neutropenia (ANC less than 500) and severe anemia (hemoglobin less than 8 g/dL) more frequently than similar patients not receiving zidovudine (neutropenia 15% vs. 9%) (anemia 5% vs.

1%). Discontinuation of zidovudine should be considered as medically appropriate.

7.2Drugs Metabolized by Cytochrome P450 In vitro studies indicate that ribavirin does not inhibit CYP 2C9, CYP 2C19, CYP 2D6 or CYP 3A4.

7.3Azathioprine The use of ribavirin to treat chronic hepatitis C in patients receiving azathioprine has been reported to induce severe pancytopenia and may increase the risk of azathioprine-related myelotoxicity. Inosine monophosphate dehydrogenase (IMDH) is required for one of the metabolic pathways of azathioprine. Ribavirin is known to inhibit IMDH, thereby leading to accumulation of an azathioprine metabolite, 6-methylthioinosine monophosphate (6-MTITP), which is associated with myelotoxicity (neutropenia, thrombocytopenia, and anemia).

Patients receiving azathioprine with ribavirin should have complete blood counts, including platelet counts, monitored weekly for the first month, twice monthly for the second and third months of treatment, then monthly or more frequently if dosage or other therapy changes are necessary [see Warnings and Precautions (5.6) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pediatrics: Safety and efficacy in pediatric patients less than 5 years old have not been established (8.4) Renal Impairment: Dose should be reduced in patients with creatinine clearance less than or equal to 50 mL/min (8.7) Organ Transplant: Safety and efficacy have not been studied (8.10)

8.1Pregnancy Pregnancy: Category X [see Contraindications (4) ] . Ribavirin produced significant embryocidal and/or teratogenic effects in all animal species in which adequate studies have been conducted. Malformations of the skull, palate, eye, jaw, limbs, skeleton, and gastrointestinal tract were noted.

The incidence and severity of teratogenic effects increased with escalation of the drug dose. Survival of fetuses and offspring was reduced [see Contraindications (4) and Warnings and Precautions (5.1) ] . In conventional embryotoxicity/teratogenicity studies in rats and rabbits, observed no-effect dose levels were well below those for proposed clinical use (0.3 mg/kg/day for both the rat and rabbit; approximately 0.06 times the recommended daily human dose of ribavirin).

No maternal toxicity or effects on offspring were observed in a peri/postnatal toxicity study in rats dosed orally at up to 1 mg/kg/day (approximately 0.01 times the maximum recommended daily human dose of ribavirin). Treatment and Post-Treatment: Potential Risk to the Fetus Ribavirin is known to accumulate in intracellular components from where it is cleared very slowly. It is not known whether ribavirin is contained in sperm, and if so, will exert a potential teratogenic effect upon fertilization of the ova.

However, because of the potential human teratogenic effects of ribavirin, male patients should be advised to take every precaution to avoid risk of pregnancy for their female partners. Ribavirin should not be used by pregnant women or by men whose female partners are pregnant. Female patients of childbearing potential and male patients with female partners of childbearing potential should not receive ribavirin unless the patient and his/her partner are using effective contraception (two reliable forms) during therapy and for 6 months post therapy [see Contraindications (4) ] .

8.3Nursing Mothers It is not known whether ribavirin is excreted in human milk. Because many drugs are excreted in human milk and to avoid any potential for serious adverse reactions in nursing infants from ribavirin, a decision should be made either to discontinue nursing or therapy with ribavirin, based on the importance of the therapy to the mother.

8.4Pediatric Use Pharmacokinetic evaluations in pediatric patients have not been performed. Safety and effectiveness of ribavirin have not been established in patients below the age of 5 years.

8.5Geriatric Use Clinical studies of ribavirin and PEGASYS ® did not include sufficient numbers of subjects aged 65 or over to determine whether they respond differently from younger subjects. Specific pharmacokinetic evaluations for ribavirin in the elderly have not been performed. The risk of toxic reactions to this drug may be greater in patients with impaired renal function.

The dose of ribavirin should be reduced in patients with creatinine clearance less than or equal to 50 mL/min; and the dose of PEGASYS ® should be reduced in patients with creatinine clearance less than 30 mL/min [see Dosage and Administration (2.4) ; Use in Specific Populations (8.7) ] .

8.6Race A pharmacokinetic study in 42 subjects demonstrated there is no clinically significant difference in ribavirin pharmacokinetics among Black (n=14), Hispanic (n=13) and Caucasian (n=15) subjects.

8.7Renal Impairment Renal function should be evaluated in all patients prior to initiation of ribavirin by estimating the patient’s creatinine clearance. A clinical trial evaluated treatment with ribavirin and PEGASYS ® in 50 CHC subjects with moderate (creatinine clearance 30 to 50 mL/min) or severe (creatinine clearance less than 30 mL/min) renal impairment or… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Pregnancy: Category X [see Contraindications (4) ] . Ribavirin produced significant embryocidal and/or teratogenic effects in all animal species in which adequate studies have been conducted. Malformations of the skull, palate, eye, jaw, limbs, skeleton, and gastrointestinal tract were noted.

The incidence and severity of teratogenic effects increased with escalation of the drug dose. Survival of fetuses and offspring was reduced [see Contraindications (4) and Warnings and Precautions (5.1) ] . In conventional embryotoxicity/teratogenicity studies in rats and rabbits, observed no-effect dose levels were well below those for proposed clinical use (0.3 mg/kg/day for both the rat and rabbit; approximately 0.06 times the recommended daily human dose of ribavirin).

No maternal toxicity or effects on offspring were observed in a peri/postnatal toxicity study in rats dosed orally at up to 1 mg/kg/day (approximately 0.01 times the maximum recommended daily human dose of ribavirin). Treatment and Post-Treatment: Potential Risk to the Fetus Ribavirin is known to accumulate in intracellular components from where it is cleared very slowly. It is not known whether ribavirin is contained in sperm, and if so, will exert a potential teratogenic effect upon fertilization of the ova.

However, because of the potential human teratogenic effects of ribavirin, male patients should be advised to take every precaution to avoid risk of pregnancy for their female partners. Ribavirin should not be used by pregnant women or by men whose female partners are pregnant. Female patients of childbearing potential and male patients with female partners of childbearing potential should not receive ribavirin unless the patient and his/her partner are using effective contraception (two reliable forms) during therapy and for 6 months post therapy [see Contraindications (4) ] .

🧒 Pediatric Use 29 words ▾

8.4Pediatric Use Pharmacokinetic evaluations in pediatric patients have not been performed. Safety and effectiveness of ribavirin have not been established in patients below the age of 5 years.

🧓 Geriatric Use 109 words ▾

8.5Geriatric Use Clinical studies of ribavirin and PEGASYS ® did not include sufficient numbers of subjects aged 65 or over to determine whether they respond differently from younger subjects. Specific pharmacokinetic evaluations for ribavirin in the elderly have not been performed. The risk of toxic reactions to this drug may be greater in patients with impaired renal function.

The dose of ribavirin should be reduced in patients with creatinine clearance less than or equal to 50 mL/min; and the dose of PEGASYS ® should be reduced in patients with creatinine clearance less than 30 mL/min [see Dosage and Administration (2.4) ; Use in Specific Populations (8.7) ] .

🆘 Overdosage 56 words ▾

10 OVERDOSAGE No cases of overdose with ribavirin have been reported in clinical trials. Hypocalcemia and hypomagnesemia have been observed in persons administered greater than the recommended dosage of ribavirin. In most of these cases, ribavirin was administered intravenously at dosages up to and in some cases exceeding four times the recommended maximum oral daily dose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ribavirin is an antiviral drug [see Microbiology ( 12.4) ] .

12.3Pharmacokinetics Multiple dose ribavirin pharmacokinetic data are available for HCV patients who received ribavirin in combination with peginterferon alfa-2a. Following administration of 1200 mg/day with food for 12 weeks mean±SD (n=39; body weight greater than 75 kg) AUC 0-12 hr was 25,361±7110 ng·hr/mL and C max was 2748±818 ng/mL. The average time to reach C max was 2 hours.

Trough ribavirin plasma concentrations following 12 weeks of dosing with food were 1662±545 ng/mL in HCV infected patients who received 800 mg/day (n=89), and 2112±810 ng/mL in patients who received 1200 mg/day (n=75; body weight greater than 75 kg). The terminal half-life of ribavirin following administration of a single oral dose of ribavirin is about 120 to 170 hours. The total apparent clearance following administration of a single oral dose of ribavirin is about 26 L/h.

There is extensive accumulation of ribavirin after multiple dosing (twice daily) such that the C max at steady state was four-fold higher than that of a single dose. Effect of Food on Absorption of Ribavirin Bioavailability of a single oral dose of ribavirin was increased by coadministration with a high-fat meal. The absorption was slowed (T max was doubled) and the AUC 0-192 h and C max increased by 42% and 66%, respectively, when ribavirin was taken with a high-fat meal compared with fasting conditions [see Dosage and Administration (2) and Patient Counseling Information (17) ] .

Elimination and Metabolism The contribution of renal and hepatic pathways to ribavirin elimination after administration of ribavirin is not known. In vitro studies indicate that ribavirin is not a substrate of CYP450 enzymes. Renal Impairment A clinical trial evaluated 50 CHC subjects with either moderate (creatinine clearance 30 to 50 mL/min) or severe (creatinine clearance less than 30 mL/min) renal impairment or end stage renal disease (ESRD) requiring chronic hemodialysis (HD).

The apparent clearance of ribavirin was reduced in subjects with creatinine clearance less than or equal to 50 mL/min, including subjects with ESRD on HD, exhibiting approximately 30% of the value found in subjects with normal renal function. Pharmacokinetic modeling and simulation indicates that a dose of 200 mg daily in patients with severe renal impairment and a dose of 200 mg daily alternating with 400 mg the following day in patients with moderate renal impairment will provide plasma ribavirin exposures similar to that observed in patients with normal renal function receiving the standard 1000/1200 mg ribavirin daily dose.

These doses have not been studied in patients. In 18 subjects with ESRD receiving chronic HD, ribavirin was administered at a dose of 200 mg daily. Ribavirin plasma exposures in these subjects were approximately 20% lower compared to subjects with normal renal function receiving the standard 1000/1200 mg ribavirin daily dose [see Dosage and Administration (2.4) , Use in Specific Populations (8.7) ] .

Plasma ribavirin is removed by hemodialysis with an extraction ratio of approximately 50%; however, due to the large volume of distribution of ribavirin, plasma exposure is not expected to change with hemodialysis.

12.4Microbiology Mechanism of Action The mechanism by which ribavirin contributes to its antiviral efficacy in the clinic is not fully understood. Ribavirin has direct antiviral activity in tissue culture against many RNA viruses. Ribavirin increases the mutation frequency in the genomes of several RNA viruses and ribavirin triphosphate inhibits HCV polymerase in a biochemical reaction.

Antiviral Activity in Cell Culture In the stable HCV cell culture model system (HCV replicon), ribavirin inhibited autonomous HCV RNA replication with a 50% effective concentration (EC 50 ) value of 11 to 21 mcM. In the same model, PEG-IFN α-2a also inhibited HCV RNA replication, with an EC 50 value… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 15 words ▾

12.1Mechanism of Action Ribavirin is an antiviral drug [see Microbiology ( 12.4) ] .

📦 How Supplied / Storage and Handling 69 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ribavirin Tablets USP, 200 mg are light pink colored, capsule shaped, film-coated tablets debossed with ‘F’ on one side and ‘10’ on the other side. Bottles of 168 NDC 65862-207-68 Bottles of 500 NDC 65862-207-05 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed.

📋 Description 124 words ▾

11 DESCRIPTION Ribavirin, is a nucleoside analogue with antiviral activity. The chemical name of ribavirin is 1-β-D-­ribofuranosyl-1 H -1,2,4-triazole-3-carboxamide and has the following structural formula: The molecular formula of ribavirin is C 8 H 12 N 4 O 5 and the molecular weight is 244.2. Ribavirin USP is a white crystalline powder.

It is freely soluble in water and slightly soluble in anhydrous alcohol. Ribavirin USP is available as a light pink colored, capsule shaped, film-coated tablet for oral administration. Each tablet contains 200 mg of ribavirin USP and the following inactive ingredients: microcrystalline cellulose, pregelatinised starch (maize), sodium starch glycolate, povidone (Kollidon 30), colloidal silicon dioxide, magnesium stearate, ethyl cellulose, triacetin, hypromellose, iron oxide red, titanium dioxide, and yellow iron oxide.

Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide) Pregnancy Patients must be informed that ribavirin may cause birth defects and/or death of the exposed fetus. Ribavirin therapy must not be used by women who are pregnant or by men whose female partners are pregnant. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients taking ribavirin therapy and for 6 months post therapy.

Patients should use two reliable methods of birth control while taking ribavirin therapy and for 6 months post therapy. Ribavirin therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Patients must perform a pregnancy test monthly during therapy and for 6 months post therapy.

Female patients of childbearing potential and male patients with female partners of childbearing potential must be advised of the teratogenic/embryocidal risks and must be instructed to practice effective contraception during ribavirin therapy and for 6 months post therapy. Patients should be advised to notify the healthcare provider immediately in the event of a pregnancy [see Contraindications (4) and Warnings and Precautions (5.1) ] . Anemia The most common adverse event associated with ribavirin is anemia, which may be severe [see Boxed Warning , Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] .

Patients should be advised that laboratory evaluations are required prior to starting ribavirin therapy and periodically thereafter [see Warnings and Precautions (5.9) ] . It is advised that patients be well hydrated, especially during the initial stages of treatment. Patients who develop dizziness, confusion, somnolence, and fatigue should be cautioned to avoid driving or operating machinery.

Patients should be advised to take ribavirin with food. Patients should be questioned about prior history of drug abuse before initiating ribavirin/PEGASYS ® , as relapse of drug addiction and drug overdoses have been reported in patients treated with interferons. Patients should be advised not to drink alcohol, as alcohol may exacerbate chronic hepatitis C infection.

Patients should be informed about what to do in the event they miss a dose of ribavirin. The missed doses should be taken as soon as possible during the same day. Patients should not double the next dose.

Patients should be advised to call their healthcare provider if they have questions. Patients should be informed that the effect of PEGASYS ® /ribavirin treatment of hepatitis C infection on transmission is not known, and that appropriate precautions to prevent transmission of hepatitis C virus during treatment or in the event of treatment failure should be taken. Patients should be informed regarding the potential benefits and risks attendant to the use of ribavirin.

Instructions on appropriate use should be given, including review of the contents of the enclosed MEDICATION GUIDE, which is not a disclosure of all or possible adverse effects. Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad–500 032, India Revised: 05/2023 Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Ribavirin Tablets, USP (rye" ba vye' rin) Read this Medication Guide carefully before you start taking ribavirin tablets and read the Medication Guide each time you get more ribavirin tablets. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Also read the Medication Guide for PEGASYS ® (peginterferon alfa-2a). What is the most important information I should know about ribavirin tablets? 1.

You should not take ribavirin tablets alone to treat chronic hepatitis C infection. Ribavirin tablets should be used with PEGASYS ® to treat chronic hepatitis C infection. 2.

Ribavirin tablets may cause you to have a blood problem (hemolytic anemia) that can worsen any heart problems you have, and cause you to have a heart attack or die. Tell your healthcare provider if you have ever had any heart problems. Ribavirin tablets may not be right for you.

If you have chest pain while you take ribavirin tablets, get emergency medical attention right away. 3. Ribavirin tablets may cause birth defects or death of your unborn baby.

If you are pregnant or your sexual partner is pregnant, do not take ribavirin tablets. You or your sexual partner should not become pregnant while you take ribavirin tablets and for 6 months after treatment is over. You must use two forms of birth control when you take ribavirin tablets and for the 6 months after treatment.

Females must have a pregnancy test before starting ribavirin tablets, every month while treated with ribavirin tablets, and every month for the 6 months after treatment with ribavirin tablets. If you or your female sexual partner becomes pregnant while taking ribavirin tablets or within 6 months after you stop taking ribavirin tablets, tell your healthcare provider right away. What are ribavirin tablets?

Ribavirin tablets are a prescription medicine used with another medicine called PEGASYS ® (peginterferon alfa-2a) to treat chronic (lasting a long time) hepatitis C infection in people 5 years and older whose liver still works normally, and who have not been treated before with a medicine called an interferon alpha. It is not known if ribavirin tablets are safe and will work in children under 5 years of age. Who should not take ribavirin tablets?

See “What is the most important information I should know about ribavirin tablets?” Do not take ribavirin tablets if you: have certain types of hepatitis caused by your immune system attacking your liver (autoimmune hepatitis) have certain blood disorders, such as thalassemia major or sickle-cell anemia (hemoglobinopathies) take didanosine (Videx or Videx EC) Talk to your healthcare provider before starting treatment with ribavirin tablets if you have any of these medical conditions. What should I tell my healthcare provider before taking ribavirin tablets?

Before you take ribavirin tablets, tell your healthcare provider if you have or have had: treatment for hepatitis C that did not work for you serious allergic reactions to ribavirin tablets or to any of the ingredients in ribavirin tablets. See the end of this Medication Guide for a list of ingredients. breathing problems. Ribavirin tablets may cause or worsen your breathing problems you already have. vision problems .

Ribavirin tablets may cause eye problems or worsen eye problems you already have. You should have an eye exam before you start treatment with ribavirin tablets. certain blood disorders such as anemia high blood pressure, heart problems or have had a heart attack . Your healthcare provider should test your blood and heart before you start treatment with ribavirin tablets. thyroid problems diabetes.

Ribavirin tablets and PEGASYS ® combination therapy may make your diabetes worse or harder to treat. liver problems other than hepatitis C virus infection human immunodeficiency virus (HIV) or other immunity problems mental health problems, including depression or thoughts of… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 59 words ▾

8.3Nursing Mothers It is not known whether ribavirin is excreted in human milk. Because many drugs are excreted in human milk and to avoid any potential for serious adverse reactions in nursing infants from ribavirin, a decision should be made either to discontinue nursing or therapy with ribavirin, based on the importance of the therapy to the mother.

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Multiple dose ribavirin pharmacokinetic data are available for HCV patients who received ribavirin in combination with peginterferon alfa-2a. Following administration of 1200 mg/day with food for 12 weeks mean±SD (n=39; body weight greater than 75 kg) AUC 0-12 hr was 25,361±7110 ng·hr/mL and C max was 2748±818 ng/mL. The average time to reach C max was 2 hours.

Trough ribavirin plasma concentrations following 12 weeks of dosing with food were 1662±545 ng/mL in HCV infected patients who received 800 mg/day (n=89), and 2112±810 ng/mL in patients who received 1200 mg/day (n=75; body weight greater than 75 kg). The terminal half-life of ribavirin following administration of a single oral dose of ribavirin is about 120 to 170 hours. The total apparent clearance following administration of a single oral dose of ribavirin is about 26 L/h.

There is extensive accumulation of ribavirin after multiple dosing (twice daily) such that the C max at steady state was four-fold higher than that of a single dose. Effect of Food on Absorption of Ribavirin Bioavailability of a single oral dose of ribavirin was increased by coadministration with a high-fat meal. The absorption was slowed (T max was doubled) and the AUC 0-192 h and C max increased by 42% and 66%, respectively, when ribavirin was taken with a high-fat meal compared with fasting conditions [see Dosage and Administration (2) and Patient Counseling Information (17) ] .

Elimination and Metabolism The contribution of renal and hepatic pathways to ribavirin elimination after administration of ribavirin is not known. In vitro studies indicate that ribavirin is not a substrate of CYP450 enzymes. Renal Impairment A clinical trial evaluated 50 CHC subjects with either moderate (creatinine clearance 30 to 50 mL/min) or severe (creatinine clearance less than 30 mL/min) renal impairment or end stage renal disease (ESRD) requiring chronic hemodialysis (HD).

The apparent clearance of ribavirin was reduced in subjects with creatinine clearance less than or equal to 50 mL/min, including subjects with ESRD on HD, exhibiting approximately 30% of the value found in subjects with normal renal function. Pharmacokinetic modeling and simulation indicates that a dose of 200 mg daily in patients with severe renal impairment and a dose of 200 mg daily alternating with 400 mg the following day in patients with moderate renal impairment will provide plasma ribavirin exposures similar to that observed in patients with normal renal function receiving the standard 1000/1200 mg ribavirin daily dose.

These doses have not been studied in patients. In 18 subjects with ESRD receiving chronic HD, ribavirin was administered at a dose of 200 mg daily. Ribavirin plasma exposures in these subjects were approximately 20% lower compared to subjects with normal renal function receiving the standard 1000/1200 mg ribavirin daily dose [see Dosage and Administration (2.4) , Use in Specific Populations (8.7) ] .

Plasma ribavirin is removed by hemodialysis with an extraction ratio of approximately 50%; however, due to the large volume of distribution of ribavirin, plasma exposure is not expected to change with hemodialysis.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Chronic Hepatitis C Patients Adult Patients The safety and effectiveness of PEGASYS ® in combination with ribavirin for the treatment of hepatitis C virus infection were assessed in two randomized controlled clinical trials. All patients were adults, had compensated liver disease, detectable hepatitis C virus, liver biopsy diagnosis of chronic hepatitis, and were previously untreated with interferon. Approximately 20% of patients in both studies had compensated cirrhosis (Child-Pugh class A).

Patients coinfected with HIV were excluded from these studies. In Study NV15801, patients were randomized to receive either PEGASYS ® 180 mcg subcutaneous once weekly with an oral placebo, PEGASYS ® 180 mcg once weekly with ribavirin 1000 mg by mouth (body weight less than 75 kg) or 1200 mg by mouth (body weight greater than or equal to 75 kg) or interferon alfa-2b 3 MIU subcutaneous three times a week plus ribavirin 1000 mg or 1200 mg by mouth. All patients received 48 weeks of therapy followed by 24 weeks of treatment-free follow-up.

Ribavirin or placebo treatment assignment was blinded. Sustained virological response was defined as undetectable (less than 50 IU/mL) HCV RNA on or after study week 68. PEGASYS ® in combination with ribavirin resulted in a higher SVR compared to PEGASYS ® alone or interferon alfa-2b and ribavirin ( Table 9 ).

In all treatment arms, patients with viral genotype 1, regardless of viral load, had a lower response rate to PEGASYS ® in combination with ribavirin compared to patients with other viral genotypes. Table 9 Sustained Virologic Response (SVR) to Combination Therapy (Study NV15801) Interferon alfa-2b + Ribavirin 1000 mg or 1200 mg PEGASYS ® + Placebo PEGASYS ® + Ribavirin 1000 mg or 1200 mg All patients 197/444 (44%) 65/224 (29%) 241/453 (53%) Genotype 1 103/285 (36%) 29/145 (20%) 132/298 (44%) Genotypes 2 to 6 94/159 (59%) 36/79 (46%) 109/155 (70%) Difference in overall treatment response (PEGASYS ® /ribavirin – Interferon alfa-2b/ribavirin) was 9% (95% CI 2.3, 15.3).

In Study NV15942, all patients received PEGASYS ® 180 mcg subcutaneous once weekly and were randomized to treatment for either 24 or 48 weeks and to a ribavirin dose of either 800 mg or 1000 mg/1200 mg (for body weight less than 75 kg/greater than or equal to 75 kg). Assignment to the four treatment arms was stratified by viral genotype and baseline HCV viral titer. Patients with genotype 1 and high viral titer (defined as greater than 2 x 10 6 HCV RNA copies/mL serum) were preferentially assigned to treatment for 48 weeks.

Sustained Virologic Response (SVR) and HCV Genotype HCV 1 and 4 - Irrespective of baseline viral titer, treatment for 48 weeks with PEGASYS ® and 1000 mg or 1200 mg of ribavirin resulted in higher SVR (defined as undetectable HCV RNA at the end of the 24-week treatment-free follow-up period) compared to shorter treatment (24 weeks) and/or 800 mg ribavirin. HCV 2 and 3 - Irrespective of baseline viral titer, treatment for 24 weeks with PEGASYS ® and 800 mg of ribavirin resulted in a similar SVR compared to longer treatment (48 weeks) and/or 1000 mg or 1200 mg of ribavirin (see Table 10 ).

The numbers of patients with genotype 5 and 6 were too few to allow for meaningful assessment. Table 10 Sustained Virologic Response as a Function of Genotype (Study NV15942) 24 Weeks Treatment 48 Weeks Treatment PEGASYS ® + Ribavirin 800 mg (N=207) PEGASYS ® + Ribavirin 1000 mg or 1200 mg* (N=280) PEGASYS ® + Ribavirin 800 mg (N=361) PEGASYS ® + Ribavirin 1000 mg or 1200 mg* (N=436) * 1000 mg for body weight less than 75 kg; 1200 mg for body weight greater than or equal to 75 kg. Genotype 1 29/101 (29%) 48/118 (41%) 99/250 (40%) 138/271 (51%) Genotypes 2, 3 79/96 (82%) 116/144 (81%) 75/99 (76%) 117/153 (76%) Genotype 4 0/5 (0%) 7/12 (58%) 5/8 (63%) 9/11 (82%) Pediatric Patients Previously untreated pediatric subjects 5 through 17 years of age (55% less than 12 years old) with chronic hepatitis C, compensated l… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a p53 (+/-) mouse carcinogenicity study up to the maximum tolerated dose of 100 mg/kg/day, ribavirin was not oncogenic. Ribavirin was also not oncogenic in a rat 2-year carcinogenicity study at doses up to the maximum tolerated dose of 60 mg/kg/day. On a body surface area basis, these doses are approximately 0.5 and 0.6 times the maximum recommended daily human dose of ribavirin, respectively.

Mutagenesis Ribavirin demonstrated mutagenic activity in the in vitro mouse lymphoma assay. No clastogenic activity was observed in an in vivo mouse micronucleus assay at doses up to 2000 mg/kg. However, results from studies published in the literature show clastogenic activity in the in vivo mouse micronucleus assay at oral doses up to 2000 mg/kg.

A dominant lethal assay in rats was negative, indicating that if mutations occurred in rats they were not transmitted through male gametes. Impairment of Fertility In a fertility study in rats, ribavirin showed a marginal reduction in sperm counts at the dose of 100 mg/kg/day with no effect on fertility. Upon cessation of treatment, total recovery occurred after 1 spermatogenesis cycle.

Abnormalities in sperm were observed in studies in mice designed to evaluate the time course and reversibility of ribavirin-induced testicular degeneration at doses of 15 to 150 mg/kg/day (approximately 0.1 to 0.8 times the maximum recommended daily human dose of ribavirin) administered for 3 to 6 months. Upon cessation of treatment, essentially total recovery from ribavirin-induced testicular toxicity was apparent within 1 or 2 spermatogenic cycles. Female patients of childbearing potential and male patients with female partners of childbearing potential should not receive ribavirin unless the patient and his/her partner are using effective contraception (two reliable forms).

Based on a multiple dose half-life (t 1/2 ) of ribavirin of 12 days, effective contraception must be utilized for 6 months post therapy (i.e., 15 half-lives of clearance for ribavirin). No reproductive toxicology studies have been performed using PEGASYS ® in combination with ribavirin. However, peginterferon alfa-2a and ribavirin when administered separately, each has adverse effects on reproduction.

It should be assumed that the effects produced by either agent alone would also be caused by the combination of the two agents.

13.2Animal Toxicology In a study in rats, it was concluded that dominant lethality was not induced by ribavirin at doses up to 200 mg/kg for 5 days (up to 1.7 times the maximum recommended human dose of ribavirin). Long-term studies in the mouse and rat (18 to 24 months; dose 20 to 75, and 10 to 40 mg/kg/day, respectively, approximately 0.1 to 0.4 times the maximum daily human dose of ribavirin) have demonstrated a relationship between chronic ribavirin exposure and an increased incidence of vascular lesions (microscopic hemorrhages) in mice.

In rats, retinal degeneration occurred in controls, but the incidence was increased in ribavirin-treated rats.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a p53 (+/-) mouse carcinogenicity study up to the maximum tolerated dose of 100 mg/kg/day, ribavirin was not oncogenic. Ribavirin was also not oncogenic in a rat 2-year carcinogenicity study at doses up to the maximum tolerated dose of 60 mg/kg/day. On a body surface area basis, these doses are approximately 0.5 and 0.6 times the maximum recommended daily human dose of ribavirin, respectively.

Mutagenesis Ribavirin demonstrated mutagenic activity in the in vitro mouse lymphoma assay. No clastogenic activity was observed in an in vivo mouse micronucleus assay at doses up to 2000 mg/kg. However, results from studies published in the literature show clastogenic activity in the in vivo mouse micronucleus assay at oral doses up to 2000 mg/kg.

A dominant lethal assay in rats was negative, indicating that if mutations occurred in rats they were not transmitted through male gametes. Impairment of Fertility In a fertility study in rats, ribavirin showed a marginal reduction in sperm counts at the dose of 100 mg/kg/day with no effect on fertility. Upon cessation of treatment, total recovery occurred after 1 spermatogenesis cycle.

Abnormalities in sperm were observed in studies in mice designed to evaluate the time course and reversibility of ribavirin-induced testicular degeneration at doses of 15 to 150 mg/kg/day (approximately 0.1 to 0.8 times the maximum recommended daily human dose of ribavirin) administered for 3 to 6 months. Upon cessation of treatment, essentially total recovery from ribavirin-induced testicular toxicity was apparent within 1 or 2 spermatogenic cycles. Female patients of childbearing potential and male patients with female partners of childbearing potential should not receive ribavirin unless the patient and his/her partner are using effective contraception (two reliable forms).

Based on a multiple dose half-life (t 1/2 ) of ribavirin of 12 days, effective contraception must be utilized for 6 months post therapy (i.e., 15 half-lives of clearance for ribavirin). No reproductive toxicology studies have been performed using PEGASYS ® in combination with ribavirin. However, peginterferon alfa-2a and ribavirin when administered separately, each has adverse effects on reproduction.

It should be assumed that the effects produced by either agent alone would also be caused by the combination of the two agents.

📄 Package Label / Principal Display Panel 42 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (168 Tablet Bottle) NDC 65862-207-68 Rx only Ribavirin Tablets, USP 200 mg PHARMACIST: DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELY TO EACH PATIENT. AUROBINDO 168 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (168 Tablet Bottle)

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
168 tablets65862-0207-68 154 Rx · $11,785
500 tablets65862-0207-05 No Medicaid data
3000 tablets this page65862-0207-39 No Medicaid data
Drug total (last 4 qtrs): 154 Rx · 11,962 units · $11,785 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Ribavirin — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Ribavirin. 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
$79.7K
Claims incl. refills
673
Beneficiaries
535
Spend / beneficiary
$149.05
Spend / claim
$118.49
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 ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The 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 Aurobindo Pharma Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 168 tablets (65862-0207-68), 500 tablets (65862-0207-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Aurobindo Pharma Limited 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.
← 65862-0206-37 · Aurobindo 65862-0208-04 · Aurobindo →
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.