Home › NDC Lookup › Ingredients › Lamivudine › 31722-0752-32
Lamivudine 100 mg Tablet, Film Coated, 100-count — NDC 31722-0752-32 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lamivudine 100 mg Tablet, Film Coated, 100-count — NDC 31722-752-32 (Billing 31722-0752-32)

by Camber Pharmaceuticals, Inc. · 100 TABLET, FILM COATED in 1 CARTON

This is a package of 100 tablets of Lamivudine 100 mg Tablet, Film Coated from Camber Pharmaceuticals, Inc., marketed since Jan 2014 and currently FDA-listed.

NDC 31722-0752-32
🏷️ FDA NDC (as labeled) 31722-752-32 billing pads the product segment with a zero
This package
Contains100-count Pack sizes4 compare ↓
Also priced by: Part D plans $9.11/unit — full pricing hub ↓
Product page 31722-0752-60 Also comes in: 10 tablets 31722-752-31 60 tablets 31722-752-60 600 tablets 31722-752-06
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 13, 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

NDC database record

One package, one record: these facts belong to NDC 31722-752-32 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
31722 labeler · 752 product · 32 package
Package marketed since
Jan 2, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 3172275232 9
FDA record last changed
Aug 13, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 31722-752-32
Product NDC 31722-752
11-digit billing NDC 31722075232
RxCUI 205328
UNII 2T8Q726O95
Application # ANDA203260
SPL Set ID 6bd6b9da-df69-46db-813e-4e7f3bdecf95
Established class (EPC) Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of action Nucleoside Reverse Transcriptase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-01-02
Route ORAL
Dosage form TABLET, FILM COATED
Substance LAMIVUDINE
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 041033
GCN 50912
HICL code 010215
Ingredient (HICL) Lamivudine
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W5
Therapeutic class — intermediate (HIC2) Antiviral Agents
HIC3 code W5F
Therapeutic class — specific (HIC3) Hepatitis B Treatment Agents
AHFS code 08:18.08.20
AHFS class Hiv Nucleoside, Nucleotide Rt Inhibitors
FDB label name LAMIVUDINE HBV 100 MG TABLET
FDB brand name Lamivudine Hbv
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 041033
  • GCN: 50912
  • HICL (First Databank): 010215
  • AHFS class code: 08:18.08.20
  • RxCUI (RxNorm): 205328
Why two NDCs? The FDA registers this code as 31722-752-32 — 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 → 31722-0752-32. 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 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor class.

Pharmacologic class Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Drug family (ATC) Nucleoside and nucleotide reverse transcriptase inhibitors
How it works Nucleoside Reverse Transcriptase Inhibitors
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 LAMIVUDINE HBV 100 MG TABLET Ingredient Lamivudine
📖 What it is MedlinePlus · NLM

Lamivudine is used to treat human immunodeficiency virus (HIV) infection. Lamivudine is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by decreasing the amount of HIV in the blood. Although lamivudine will not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses. Taking these medications and making other lifestyle changes may also decrease the risk of giving the HIV virus to other people.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Lamivudine treats HIV-1 infection when combined with other HIV medicines. A separate lower-dose tablet treats chronic hepatitis B. Make sure you have the version your doctor prescr...
  • For HIV-1 it is taken by mouth once or twice daily, with or without food. Follow your prescriber's schedule exactly. Children's doses depend on weight.
  • Common ones are headache, nausea, tiredness, stuffy nose, diarrhea and cough. Call your doctor if you notice signs of liver problems, pancreatitis, or an allergic reaction.
  • Please don't stop on your own. If you also have hepatitis B, stopping can cause a serious flare-up, and your liver needs close monitoring afterward. Talk to your doctor first.
📖 Read our full Lamivudine 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 · Q2 2026 $9.11 $911.05 / 100 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
31722-0752-06 31722-752-06 600 TABLET, FILM COATED in 1 BOTTLE — — 2014-01-02 — Active
31722-0752-31 31722-752-31 10 TABLET, FILM COATED in 1 BLISTER PACK — — 2014-01-02 — Active
31722-0752-32 You're viewing this 100 TABLET, FILM COATED in 1 CARTON — — 2014-01-02 — Active
31722-0752-60 31722-752-60 Main listing 60 TABLET, FILM COATED in 1 BOTTLE $1.55 / ea $93.29 2014-01-02 — Active

You're viewing one of 4 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet, film coated in 1 carton.
How does this package differ from NDC 31722-0752-31?
Both are Lamivudine 100 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 100-count one, while NDC 31722-0752-31 is the 10 tablets package.
What NDC number is used to bill for this package of Lamivudine 100 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
Lamivudine 100 mg 60505-3250-06 Apotex 60 tablets $9.476 AB Availability likely —
lamivudine 100 mg 31722-0001-02 Camber 10 tablets — AB FDA listed —
Lamivudine 100 mgthis 31722-0752-32 Camber 100 tablets — AB FDA listed —
Lamivudine 100 mg 51407-0866-60 Golden 60 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

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 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
Imprint37;I
Size12 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.

🧪 Avoiding an ingredient? See Lamivudine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII S870P55O2W
    Isomalt is a sugar alcohol made from sugar that's used as a sweetener and bulking agent in medicines. It helps give tablets and powders the right texture and sweetness while having minimal calories.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • 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 588X2YUY0A
    Methylene chloride is a volatile organic solvent used in pharmaceutical manufacturing to dissolve and process active ingredients and other substances. It evaporates during production, helping create tablets, capsules, or coatings with uniform quality.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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

LabelerCamber Pharmaceuticals, Inc.
Application holderHETERO LABS LTD UNIT V
FDA applicationANDA203260 (ANDA)
Labeler code31722
First marketedJan 2014
Product typeHuman Prescription Drug
Portfolio603 products on file

More NDCs from Camber Pharmaceuticals, Inc. labeler code 31722

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 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: EXACERBATIONS OF HEPATITIS B and RISK OF HIV-1 RESISTANCE IF LAMIVUDINE TABLETS (HBV) IS USED IN PATIENTS WITH UNRECOGNIZED OR UNTREATED HIV-1 INFECTION Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy (including lamivudine tablets (HBV). Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ].

Lamivudine tablets (HBV) are not approved for the treatment of human immunodeficiency virus type 1 (HIV-1) infection because the lamivudine dosage in lamivudine tablets (HBV) is subtherapeutic and monotherapy is inappropriate for the treatment of HIV-1 infection. HIV-1 resistance may emerge in chronic hepatitis B-infected patients with unrecognized or untreated HIV-1 infection. HIV counseling and testing should be offered to all patients before beginning treatment with lamivudine tablets (HBV) and periodically during treatment [see Warnings and Precautions (5.2) ].

WARNING: EXACERBATIONS OF HEPATITIS B and RISK OF HIV-1 RESISTANCE IF LAMIVUDINE TABLETS (HBV) IS USED IN PATIENTS WITH UNRECOGNIZED OR UNTREATED HIV-1 INFECTION See full prescribing information for complete boxed warning • Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy (including lamivudine tablets (HBV). Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment. ( 5.1 ) • Lamivudine tablets (HBV) contain a lower dose of the same active ingredient (lamivudine) as lamivudine tablets and oral solution used to treat human immunodeficiency virus type 1 (HIV-1) infection.

HIV-1 resistance may emerge in chronic hepatitis B patients with unrecognized or untreated HIV-1 infection because the lamivudine dosage in lamivudine tablets (HBV) is subtherapeutic and monotherapy is inappropriate for the treatment of HIV-1 infection. HIV counseling and testing should be offered to all patients before beginning treatment with lamivudine tablets (HBV) and periodically during treatment. ( 5.2 )

🎯 Indications and Usage 179 words ▾

1 INDICATIONS AND USAGE Lamivudine tablets (HBV) are indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation [see Clinical Studies ( 14.1 , 14.2 )]. The following points should be considered when initiating therapy with lamivudine tablets (HBV): • Due to high rates of resistance development in treated patients, initiation of treatment with lamivudine tablets (HBV) should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate. • Lamivudine tablets (HBV) have not been evaluated in patients co-infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis delta virus. • Lamivudine tablets (HBV) have not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease.

Lamivudine tablets (HBV) are a nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Adults: 100 mg, once daily. ( 2.2 ) • Pediatric Patients aged 2 to 17 years: 3 mg per kg once daily up to 100 mg once daily. Prescribe oral solution for pediatric patients requiring less than 100 mg daily.

( 2.3) • Patients with Renal Impairment: Doses of lamivudine tablets (HBV) must be adjusted in accordance with renal function. ( 2.4 ) • Lamivudine tablets (HBV) should not be used with other medications that contain lamivudine or emtricitabine. ( 2.5)

2.1HIV Counseling and Testing HIV counseling and testing should be offered to all patients before beginning treatment with lamivudine tablets (HBV) and periodically during treatment because of the risk of emergence of resistant human immunodeficiency virus type 1 (HIV-1) and limitation of treatment options if lamivudine tablets (HBV) is prescribed to treat chronic hepatitis B infection in a patient who has unrecognized HIV-1 infection or acquires HIV-1 infection during treatment [see Warnings and Precautions ( 5.2 )] .

2.2Recommended Dosage for Adult Patients The recommended oral dosage of lamivudine tablets (HBV) is 100 mg once daily.

2.3Recommended Dosage for Pediatric Patients The recommended oral dosage of lamivudine tablets (HBV) for pediatric patients aged 2 to 17 years is 3 mg per kg once daily up to a maximum daily dosage of 100 mg. The oral solution formulation should be prescribed for patients requiring a dosage less than 100 mg or if unable to swallow tablets.

2.4Patients with Renal Impairment Dosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Clinical Pharmacology ( 12.3 )] . Table 1. Dosage of Lamivudine Tablets (HBV) in Adult Patients with Renal Impairment Cre atinine Clearance ( m L/min) Rec o mme nded Dosage of Lamivudine Tablets (HBV) ≥50 100 mg once daily 30 to 49 100 mg first dose, then 50 mg once daily 15 to 29 100 mg first dose, then 25 mg once daily 5 to 14 35 mg first dose, then 15 mg once daily <5 35 mg first dose, then 10 mg once daily Following correction of the dosage for renal impairment, no additional dosage modification of lamivudine tablets (HBV) is required after routine (4-hour) hemodialysis or peritoneal dialysis [see Clinical Pharmacology ( 12.3) ] .

There are insufficient data to recommend a specific dosage of lamivudine tablets (HBV) in pediatric patients with renal impairment.

2.5Important Administration Instructions • Lamivudine tablets (HBV) may be administered with or without food. • The tablets and oral solution may be used interchangeably [see Clinical Pharmacology ( 12.3)]. • The oral solution should be used for doses less than 100 mg. • Lamivudine tablets (HBV) should not be used with other medications that contain lamivudine or medications that contain emtricitabine.

2.6Assessing Patients during Treatment Patients should be monitored regularly during treatment by a physician experienced in the management of chronic hepatitis B. During treatment, combinations of events such as return of persistently elevated ALT, increasing levels of HBV DNA over time after an initial decline below assay limit, progression of clinical signs or symptoms of hepatic disease, and/or worsening of hepatic necroinflammatory findings may be considered as potentially reflecting loss of therapeutic response.

Such observations should be taken into consideration when determining the advisability of continuing therapy with lamivudine tablets (HBV). The optimal duration of treatment, the durability of HBeAg seroconversions occurring during treatment, and the relationship between treatment response and long-term outcomes such as hepatocellular carcinoma or decompensated cirrhosis are not known.

💊 Dosage Forms and Strengths 39 words ▾

3 DOSAGE FORMS AND STRENGTHS • Lamivudine tablets (HBV): 100 mg are pink colored, capsule shaped, biconvex, film coated tablets, debossed with ‘37’ on one side and ‘I’ on the other side. • Tablets: 100 mg ( 3 )

⛔ Contraindications 30 words ▾

4 CONTRAINDICATIONS Lamivudine tablets (HBV) are contraindicated in patients with a previous hypersensitivity reaction to lamivudine. Lamivudine tablets (HBV) is contraindicated in patients with previous hypersensitivity reaction to lamivudine. (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Emergence of Resistance-Associated HBV Substitutions: Consider a switch to an alternative regimen if serum HBV DNA remains detectable after 24 weeks of treatment. ( 2.6 , 5.3 ) • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. ( 5.4 )

5.1Exacerbations of Hepatitis after Discontinuation of Treatment Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine. These exacerbations have been detected primarily by serum ALT elevations in addition to re-emergence of HBV DNA commonly observed after stopping treatment; see Table 4 for more information regarding frequency of posttreatment ALT elevations [see Adverse Reactions (6.1) ]. Although most events appear to have been self-limited, fatalities have been reported in some cases.

The causal relationship to discontinuation of lamivudine treatment is unknown. Patients should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment with lamivudine tablets (HBV). There is insufficient evidence to determine whether re-initiation of lamivudine tablets (HBV) alters the course of posttreatment exacerbations of hepatitis.

5.2Risk of HIV-1 Resistance if lamivudine tablets (HBV) is Used in Patients with Unrecognized or Untreated HIV-1 Infection Lamivudine tablets (HBV) contain a lower lamivudine dose than the lamivudine dose used to treat HIV-1 infection with lamivudine tablets and oral solution or with lamivudine- containing antiretroviral fixed-dose combination products. Lamivudine tablets (HBV) is not appropriate for patients co-infected with HBV and HIV-1. If a patient with unrecognized or untreated HIV-1 infection is prescribed lamivudine tablets (HBV) for the treatment of HBV, rapid emergence of HIV-1 resistance is likely to result because of the sub therapeutic dose and the inappropriate use of monotherapy for HIV-1 treatment.

HIV counseling and testing should be offered to all patients before beginning treatment with lamivudine tablets (HBV) and periodically during treatment because of the risk of rapid emergence of resistant HIV-1 and limitation of treatment options if lamivudine tablets (HBV) is prescribed to treat chronic hepatitis B in a patient who has unrecognized or untreated HIV-1 infection or who acquires HIV-1 infection during treatment.

5.3Emergence of Resistance-Associated HBV Substitutions In controlled clinical trials, YMDD-mutant HBV was detected in subjects with on– lamivudine tablets (HBV) re-appearance of HBV DNA after an initial decline below the assay limit [see Microbiology (12.4) ]. Subjects treated with lamivudine tablets (HBV) (adults and children) with YMDD-mutant HBV at 52 weeks showed diminished treatment responses in comparison with subjects treated with lamivudine tablets (HBV) without evidence of YMDD substitutions, including the following: lower rates of HBeAg seroconversion and HBeAg loss (no greater than placebo recipients), more frequent return of positive HBV DNA, and more frequent ALT elevations.

In the controlled trials, when subjects developed YMDD-mutant HBV, they had a rise in HBV DNA and ALT from their previous on-treatment levels. Progression of hepatitis B, including death, has been reported in some subjects with YMDD-mutant HBV, including subjects from the liver transplant setting and from other clinical trials. In order to reduce the risk of resistance in patients receiving monotherapy with lamivudine tablets (HBV), a switch to an alternative regimen should be considered if serum HBV DNA remains detectable after 24 weeks of treatment.

Optimal therapy should be guided by resistance testing.

5.4Lactic Acidosis and Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including lamivudine tablets (H… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: • Exacerbations of hepatitis B after discontinuation of treatment [see Warnings and Precautions (5.1) ]. • Risk of emergence of resistant HIV-1 infection [see Warnings and Precautions (5.2) ]. • Risk of emergence of resistant HBV infection [see Warnings and Precautions (5.3) ]. • Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions (5.4) ]. The most common reported adverse reactions in those receiving lamivudine tablets (HBV) (incidence greater than or equal to 10% and reported at a rate greater than placebo) were ear, nose, and throat infections; sore throat; and diarrhea.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 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 with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical Trials Experience in Adult Subjects with Chronic HBV Infection Clinical adverse reactions (regardless of investigator’s causality assessment) reported in greater than or equal to 10% of subjects who received lamivudine tablets (HBV) and reported at a rate greater than in subjects who received placebo are listed in Table 2.

Table 2. Clinical Adverse Reactions a Reported in Greater than or Equal to 10% of Subjects Who Received Lamivudine Tablets (HBV) for 52 to 68 Weeks and at an Incidence Greater than Placebo (Trials 1 to 3) Adverse Event Lamivudine Tablets (HBV) (n = 332) P lacebo ( n = 200) Ear, Nose, and Throat Ear, nose, and throat infections 25% 21% Sore throat 13% 8% G astrointestinal Diarrhea 14% 12% a Includes adverse events regardless of severity and causality assessment. Specified laboratory abnormalities reported in subjects who received lamivudine tablets (HBV) and reported at a rate greater than in subjects who received placebo are listed in Table 3.

Table 3. Frequencies of Specified Laboratory Abnormalities Reported during Treatment at a Greater Frequency in Subjects Treated with Lamivudine Tablets (HBV) than with Placebo (Trials 1 to 3) a Test (A bnormal Level) Subjects with Abnormality/ Subjects with Observations Lamivudine Tablets (HBV) P lacebo Serum Lipase ≥2.5 x ULN b 10% 7% Creatine Phosphokinase (CPK) ≥7 x baseline 9% 5% Platelets <50,000/mm 3 4% 3% a Includes subjects treated for 52 to 68 weeks. b Includes observations during and after treatment in the 2 placebo-controlled trials that collected this information.

ULN = Upper limit of normal. In subjects followed for up to 16 weeks after discontinuation of treatment, posttreatment ALT elevations were observed more frequently in subjects who had received lamivudine tablets (HBV) than in subjects who had received placebo. A comparison of ALT elevations between Weeks 52 and 68 in subjects who discontinued lamivudine tablets (HBV) at Week 52 and subjects in the same trials who received placebo throughout the treatment course is shown in Table 4.

Table 4. Posttreatment ALT Elevations with No-Active-Treatment Follow-up (Trials 1 and 3) A bnormal Value Subjects with ALT Elevation/ Subjects with Observations a Lamivudine Tablets (HBV) b P lacebo b ALT ≥2 x baseline value 27% 19% ALT ≥3 x baseline value c 21% 8% ALT ≥2 x baseline value and absolute ALT >500 IU/L 15% 7% ALT ≥2 x baseline value; and bilirubin >2 x ULN and ≥2 x baseline value 0.7% 0.9% a Each subject may be represented in one or more category. b During treatment phase. c Comparable to a Grade 3 toxicity in accordance with modified WHO criteria.

ULN = Upper limit of normal. Clinical Trials Experience in Pediatric Subjects with Chronic HBV Infection Most commonly observed adverse reactions in the pediatric trials were similar to those in adult trials. Po… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 153 words ▾

7 DRUG INTERACTIONS Sorbitol: Coadministration of lamivudine and sorbitol may result in decreased lamivudine concentrations; when possible, avoid chronic coadministration. Consider more frequent monitoring of HBV viral load when chronic coadministration cannot be avoided. (7.2)

7.1Drugs Inhibiting Organic Cation Transporters Lamivudine is predominantly eliminated in the urine by active organic cationic secretion. The possibility of interactions with other drugs administered concurrently should be considered, particularly when their main route of elimination is active renal secretion via the organic cationic transport system (e.g., trimethoprim) [see Clinical Pharmacology (12.3)]. No data are available regarding interactions with other drugs that have renal clearance mechanisms similar to that of lamivudine.

7.2Sorbitol Coadministration of single doses of lamivudine and sorbitol resulted in a sorbitol dose-dependent reduction in lamivudine exposures. When possible, avoid use of sorbitol-containing medicines with lamivudine [see Clinical Pharmacology (12.3]. Consider more frequent monitoring of HBV viral load when chronic coadministration cannot be avoided.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no substantial difference in the risk of overall major birth defects for lamivudine compared with the background rate for major birth defects of 2.7% reported in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP).

The APR uses the MACDP as a U.S. reference population for birth defects in the general population. The MACDP evaluates women and infants from a limited geographic area and does not include outcomes for births that occur at less than 20 weeks’ gestation. Of over 12,900 women exposed to lamivudine in the APR, less than 2% were HBV mono-infected.

The majority of women exposed to lamivudine in the APR were HIV-1-infected and were treated with higher doses of lamivudine compared with HBV mono-infected women. In addition to lamivudine, HIV-1-infected women were also treated with other concomitant medications for HIV-1 infection (see Data) . The estimated rate of miscarriage for women exposed to lamivudine in the indicated population is unknown.

The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%. Oral administration of lamivudine to pregnant rabbits during organogenesis resulted in embryolethality at systemic exposure (AUC) similar to the recommended clinical dose; however, no adverse developmental effects were observed with oral administration of lamivudine to pregnant rats during organogenesis at plasma concentrations (C max ) 60 times the recommended clinical dose (see Data) . Data Human Data : Based on prospective reports from the APR of over 12,900 exposures to lamivudine during pregnancy resulting in live births (including over 5,400 exposed in the first trimester and over 7,500 exposed in the second/third trimester), there was no difference between the overall risk of birth defects with lamivudine compared with the background birth defect rate of 2.7% observed in the U.S. reference population of the MACDP.

The prevalence of birth defects in live births was 3.1% (95% CI: 2.7% to 3.6%) following first trimester exposure to lamivudine-containing regimens and 2.9% (95% CI: 2.5% to 3.3%) following second/third trimester exposure to lamivudine-containing regimens. The pharmacokinetics of lamivudine in patients with HBV or HIV-1 infection and in healthy volunteers are similar at similar doses. Lamivudine pharmacokinetics were studied in pregnant women with HIV-1 infection during 2 clinical trials conducted in South Africa.

The trials assessed pharmacokinetics in 16 women at 36 weeks’ gestation using 150 mg lamivudine twice daily (3 times the recommended daily dosage for HBV) with zidovudine, 10 women at 38 weeks’ gestation using 150 mg lamivudine twice daily (3 times the recommended daily dosage for HBV) with zidovudine, and 10 women at 38 weeks’ gestation using lamivudine 300 mg twice daily (6 times the recommended daily dosage for HBV) without other antiretrovirals. Lamivudine concentrations were generally similar in maternal, neonatal, and umbilical cord serum samples.

In a subset of subjects, amniotic fluid specimens were collected following natural rupture of membranes and confirmed that lamivudine crosses the placenta in humans. Based on limited data at delivery, median (range) amniotic fluid concentrations of lamivudine were 3.9- (1.2- to 12.8-) fold greater compared with paired maternal serum concentrations (n = 8). Animal Data : Lamivudine was administered orally to pregnant rats (at 90, 600, and 4,000 mg per kg per day) and rabbits (at 90, 300, and 1,000 mg per kg per day and at 15, 40, and 90 mg per kg per day) during organogenesis (o… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no substantial difference in the risk of overall major birth defects for lamivudine compared with the background rate for major birth defects of 2.7% reported in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP).

The APR uses the MACDP as a U.S. reference population for birth defects in the general population. The MACDP evaluates women and infants from a limited geographic area and does not include outcomes for births that occur at less than 20 weeks’ gestation. Of over 12,900 women exposed to lamivudine in the APR, less than 2% were HBV mono-infected.

The majority of women exposed to lamivudine in the APR were HIV-1-infected and were treated with higher doses of lamivudine compared with HBV mono-infected women. In addition to lamivudine, HIV-1-infected women were also treated with other concomitant medications for HIV-1 infection (see Data) . The estimated rate of miscarriage for women exposed to lamivudine in the indicated population is unknown.

The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%. Oral administration of lamivudine to pregnant rabbits during organogenesis resulted in embryolethality at systemic exposure (AUC) similar to the recommended clinical dose; however, no adverse developmental effects were observed with oral administration of lamivudine to pregnant rats during organogenesis at plasma concentrations (C max ) 60 times the recommended clinical dose (see Data) . Data Human Data : Based on prospective reports from the APR of over 12,900 exposures to lamivudine during pregnancy resulting in live births (including over 5,400 exposed in the first trimester and over 7,500 exposed in the second/third trimester), there was no difference between the overall risk of birth defects with lamivudine compared with the background birth defect rate of 2.7% observed in the U.S. reference population of the MACDP.

The prevalence of birth defects in live births was 3.1% (95% CI: 2.7% to 3.6%) following first trimester exposure to lamivudine-containing regimens and 2.9% (95% CI: 2.5% to 3.3%) following second/third trimester exposure to lamivudine-containing regimens. The pharmacokinetics of lamivudine in patients with HBV or HIV-1 infection and in healthy volunteers are similar at similar doses. Lamivudine pharmacokinetics were studied in pregnant women with HIV-1 infection during 2 clinical trials conducted in South Africa.

The trials assessed pharmacokinetics in 16 women at 36 weeks’ gestation using 150 mg lamivudine twice daily (3 times the recommended daily dosage for HBV) with zidovudine, 10 women at 38 weeks’ gestation using 150 mg lamivudine twice daily (3 times the recommended daily dosage for HBV) with zidovudine, and 10 women at 38 weeks’ gestation using lamivudine 300 mg twice daily (6 times the recommended daily dosage for HBV) without other antiretrovirals. Lamivudine concentrations were generally similar in maternal, neonatal, and umbilical cord serum samples.

In a subset of subjects, amniotic fluid specimens were collected following natural rupture of membranes and confirmed that lamivudine crosses the placenta in humans. Based on limited data at delivery, median (range) amniotic fluid concentrations of lamivudine were 3.9- (1.2- to 12.8-) fold greater compared with paired maternal serum concentrations (n = 8). Animal Data : Lamivudine was administered orally to pregnant rats (at 90, 600, and 4,000 mg per kg per day) and rabbits (at 90, 300, and 1,000 mg per kg per day and at 15, 40, and 90 mg per kg per day) during organogenesis (on Gestation Days 7 through 16… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 62 words ▾

8.4Pediatric Use Lamivudine tablets (HBV) is indicated for the treatment of chronic hepatitis B virus infection in pediatric patients aged 2 to 17 years [see Indications and Usage ( 1 ), Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.2 )] . The safety and efficacy of lamivudine tablets (HBV) in pediatric patients younger than 2 years have not been established.

🧓 Geriatric Use 72 words ▾

8.5Geriatric Use Clinical trials of lamivudine tablets (HBV) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, caution should be exercised in the administration of lamivudine tablets (HBV) in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Dosage and Administration (2.4), Clinical Pharmacology (12.3)].

🆘 Overdosage 64 words ▾

10 OVERDOSAGE There is no known specific treatment for overdose with lamivudine tablets (HBV). If overdose occurs, the patient should be monitored and standard supportive treatment applied, as required. Because a negligible amount of lamivudine was removed via (4-hour) hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous hemodialysis would provide clinical benefit in a lamivudine overdose event.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Lamivudine is an antiviral agent with activity against HBV [see Microbiology ( 12.4 )].

12.3Pharmacokinetics Pharmacokinetics in Adults The pharmacokinetic properties of lamivudine have been studied as single and multiple oral doses ranging from 5 mg to 600 mg per day administered to HBV-infected subjects. Absorption and Bioavailability: Following single oral doses of 100 mg, the peak serum lamivudine concentration (C max ) in HBV-infected patients (steady state) and healthy subjects (single dose) was 1.28 ± 0.56 mcg per mL and 1.05 ± 0.32 mcg per mL (mean ± SD), respectively, which occurred between 0.5 and 2 hours after administration.

The area under the plasma concentration versus time curve (AUC [0 to 24h] ) following 100-mg lamivudine oral single and repeated daily doses to steady state was 4.3 ± 1.4 (mean ± SD) and 4.7 ± 1.7 mcg•hour per mL, respectively. The relative bioavailability of the tablet and oral solution were demonstrated in healthy subjects. Although the solution demonstrated a slightly higher peak serum concentration (C max ), there was no significant difference in systemic exposure (AUC) between the oral solution and the tablet.

Therefore, the oral solution and the tablet may be used interchangeably. After oral administration of lamivudine once daily to HBV-infected adults, the AUC and C max increased in proportion to dose over the range from 5 mg to 600 mg once daily. Absolute bioavailability in 12 adult subjects was 86% ± 16% (mean ± SD) for the 150-mg tablet and 87% ± 13% for the 10-mg-per mL oral solution.

Effects of Food on Oral Absorption: Lamivudine tablets (HBV) may be administered with or without food. The 100-mg tablet was administered orally to 24 healthy subjects on 2 occasions, once in the fasted state and once with food (standard meal: 967 kcal; 67 grams fat, 33 grams protein, 58 grams carbohydrate). There was no significant difference in systemic exposure (AUC) in the fed and fasted states.

Distribution: The apparent volume of distribution after IV administration of lamivudine to 20 HIV-1-infected subjects was 1.3 ±

0.4L per kg, suggesting that lamivudine distributes into extravascular spaces. Volume of distribution was independent of dose and did not correlate with body weight. Binding of lamivudine to human plasma proteins is less than 36%.

In vitro studies showed that over the concentration range of 0.1 to 100 mcg per mL, the amount of lamivudine associated with erythrocytes ranged from 53% to 57% and was independent of concentration. Metabolism: Metabolism of lamivudine is a minor route of elimination. In humans, the only known metabolite of lamivudine is the trans-sulfoxide metabolite (approximately 5% of an oral dose after 12 hours).

Serum concentrations of this metabolite have not been determined. Lamivudine is not significantly metabolized by cytochrome P450 enzymes. Elimination: The majority of lamivudine is eliminated unchanged in urine by active organic cationic secretion.

In 9 healthy subjects given a single 300-mg oral dose of lamivudine, renal clearance was 199.7 ± 56.9 mL per min (mean ± SD). In 20 HIV-1-infected subjects given a single IV dose, renal clearance was 280.4 ± 75.2 mL per min (mean ± SD), representing 71% ± 16% (mean ± SD) of total clearance of lamivudine. In most single-dose trials with plasma sampling for up to 48 or 72 hours after dosing, the observed mean elimination half-life (t½) ranged from 13 to 19 hours.

In HIV-1-infected subjects, total clearance was 398.5 ± 69.1 mL per min (mean ± SD). Oral clearance and elimination half-life were independent of dose and body weight over an oral dosing range of 0.25 to 10 mg per kg. Specific Populations Patients with Renal Impairment : The pharmacokinetic properties of lamivudine have been determined in healthy adults and in adults with impaired renal function, with and without hemodialysis (Table 5).

Table 5. Pharmacokinetic Parameters (Mean ± SD) Dose-Normalized to a S… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 18 words ▾

12.1Mechanism of Action Lamivudine is an antiviral agent with activity against HBV [see Microbiology ( 12.4 )].

📦 How Supplied / Storage and Handling 78 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Lamivudine tablets (HBV), 100 mg are pink colored, capsule shaped, biconvex, film coated tablets, debossed with ‘37’ on one side and ‘I’ on the other side. Bottle of 60 tablets NDC 31722-752-60 Bottle of 600 tablets NDC 31722-752-06 Blister card of 10 Unit-dose tablets NDC 31722-752-31 Blister pack of 100 (10x10) Unit-dose tablets NDC 31722-752-32 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Preserve in well-closed, light-resistant containers.

📋 Description 119 words ▾

11 DESCRIPTION Lamivudine tablet (HBV) is a synthetic nucleoside analogue with activity against HBV. The chemical name of lamivudine, USP is 2(1H) - Pyrimidinone, 4-amino-1- [2- (hydroxymethyl)-1,3-oxathio-lan-5-yl], (2R-cis)-.It has a molecular formula of C 8 H 11 N 3 O 3 S and a molecular weight of 229.26. It has the following structural formula: Lamivudine USP is a white to an off white solid and soluble in water.

Lamivudine Tablets (HBV) are for oral administration. Each tablet contains 100 mg of lamivudine, USP and the inactive ingredients crospovidone, isomalt, isopropyl alcohol, magnesium stearate and methylene chloride. The tablets are coated with Opadry Pink containing hypromellose, iron oxide red, polyethylene glycol, polysorbate 80, titanium dioxide and yellow iron oxide. lamivudinechemicalstructure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Severe Acute Exacerbation of Hepatitis after Discontinuation of Treatment Inform patients that discontinuation of anti-hepatitis B therapy, including lamivudine tablets (HBV), may result in severe acute exacerbations of hepatitis B including decompensation of liver disease. Advise patients not to discontinue lamivudine tablets (HBV) without first informing their healthcare provider [see Warnings and Precautions ( 5.1 )].

Risk of Development of HIV-1 Resistance in Patients with HIV-1 Co-infection Counsel patients on the importance of testing for HIV to avoid inappropriate therapy and development of resistance to HIV. HIV counseling and testing should be offered before starting lamivudine tablets (HBV) and periodically during therapy. Inform patients that if they have or develop HIV infection and are not receiving effective HIV treatment, lamivudine tablets (HBV) may increase the risk of development of resistance to HIV medications.

Advise patients that lamivudine tablets (HBV) contains a lower dose of the same active ingredient (lamivudine) as HIV drugs containing lamivudine [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.2 )]. Emergence of HBV Resistance Inform patients that emergence of resistant hepatitis B virus and worsening of disease can occur during treatment. Patients should promptly report any new or worsening symptoms to their physician [see Warnings and Precautions (5.3) ].

Lactic Acidosis/Severe Hepatomegaly with Steatosis Advise patients that lactic acidosis and severe hepatomegaly with steatosis have been reported with use of nucleoside analogues and other antiretrovirals. Advise patients to stop taking lamivudine tablets (HBV) if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5.4) ]. Hepatitis B Transmission Advise patients that treatment with lamivudine tablets (HBV) has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.

Drug Interactions Inform patients that lamivudine tablets (HBV) may interact with some drugs; therefore, patients should be advised to report to their healthcare provider the use of any prescription or non-prescription medication or herbal products. Advise patients to avoid chronic use of sorbitol-containing prescription and over-the-counter medicines when possible. Taking lamivudine tablets (HBV) with chronically administered sorbitol-containing medicines may decrease the concentrations of lamivudine [see Drug Interactions ( 7.2)].

Pregnancy Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine tablets (HBV) during pregnancy [see Use in Specific Populations ( 8.1 )]. Missed Dosage Instruct patients that if they miss a dose of lamivudine tablets (HBV), to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose [see Dosage and Administration ( 2 )].

All brands listed are trademarks of their respective owners and are not trademarks of Hetero Labs Limited. Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854 By: HETERO TM Hetero Labs Limited Unit V, Polepally, Jadcherla, Mahabubnagar-509 301, India. Revised: 03/2025 lamivudinecamberlogo

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Pharmacokinetics in Adults The pharmacokinetic properties of lamivudine have been studied as single and multiple oral doses ranging from 5 mg to 600 mg per day administered to HBV-infected subjects. Absorption and Bioavailability: Following single oral doses of 100 mg, the peak serum lamivudine concentration (C max ) in HBV-infected patients (steady state) and healthy subjects (single dose) was 1.28 ± 0.56 mcg per mL and 1.05 ± 0.32 mcg per mL (mean ± SD), respectively, which occurred between 0.5 and 2 hours after administration.

The area under the plasma concentration versus time curve (AUC [0 to 24h] ) following 100-mg lamivudine oral single and repeated daily doses to steady state was 4.3 ± 1.4 (mean ± SD) and 4.7 ± 1.7 mcg•hour per mL, respectively. The relative bioavailability of the tablet and oral solution were demonstrated in healthy subjects. Although the solution demonstrated a slightly higher peak serum concentration (C max ), there was no significant difference in systemic exposure (AUC) between the oral solution and the tablet.

Therefore, the oral solution and the tablet may be used interchangeably. After oral administration of lamivudine once daily to HBV-infected adults, the AUC and C max increased in proportion to dose over the range from 5 mg to 600 mg once daily. Absolute bioavailability in 12 adult subjects was 86% ± 16% (mean ± SD) for the 150-mg tablet and 87% ± 13% for the 10-mg-per mL oral solution.

Effects of Food on Oral Absorption: Lamivudine tablets (HBV) may be administered with or without food. The 100-mg tablet was administered orally to 24 healthy subjects on 2 occasions, once in the fasted state and once with food (standard meal: 967 kcal; 67 grams fat, 33 grams protein, 58 grams carbohydrate). There was no significant difference in systemic exposure (AUC) in the fed and fasted states.

Distribution: The apparent volume of distribution after IV administration of lamivudine to 20 HIV-1-infected subjects was 1.3 ±

0.4L per kg, suggesting that lamivudine distributes into extravascular spaces. Volume of distribution was independent of dose and did not correlate with body weight. Binding of lamivudine to human plasma proteins is less than 36%.

In vitro studies showed that over the concentration range of 0.1 to 100 mcg per mL, the amount of lamivudine associated with erythrocytes ranged from 53% to 57% and was independent of concentration. Metabolism: Metabolism of lamivudine is a minor route of elimination. In humans, the only known metabolite of lamivudine is the trans-sulfoxide metabolite (approximately 5% of an oral dose after 12 hours).

Serum concentrations of this metabolite have not been determined. Lamivudine is not significantly metabolized by cytochrome P450 enzymes. Elimination: The majority of lamivudine is eliminated unchanged in urine by active organic cationic secretion.

In 9 healthy subjects given a single 300-mg oral dose of lamivudine, renal clearance was 199.7 ± 56.9 mL per min (mean ± SD). In 20 HIV-1-infected subjects given a single IV dose, renal clearance was 280.4 ± 75.2 mL per min (mean ± SD), representing 71% ± 16% (mean ± SD) of total clearance of lamivudine. In most single-dose trials with plasma sampling for up to 48 or 72 hours after dosing, the observed mean elimination half-life (t½) ranged from 13 to 19 hours.

In HIV-1-infected subjects, total clearance was 398.5 ± 69.1 mL per min (mean ± SD). Oral clearance and elimination half-life were independent of dose and body weight over an oral dosing range of 0.25 to 10 mg per kg. Specific Populations Patients with Renal Impairment : The pharmacokinetic properties of lamivudine have been determined in healthy adults and in adults with impaired renal function, with and without hemodialysis (Table 5).

Table 5. Pharmacokinetic Parameters (Mean ± SD) Dose-Normalized to a Single 100-mg Oral Dose of Lamivudine in Adults with Varying Degrees of Renal Function Parameter Creatinine Clearance Criterion (Number of… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Adult Subjects The safety and efficacy of lamivudine tablets (HBV) 100 mg once daily versus placebo were evaluated in 3 controlled trials in subjects with compensated chronic hepatitis B virus infection. All subjects were aged 16 years or older and had chronic hepatitis B virus infection (serum HBsAg-positive for at least 6 months) accompanied by evidence of HBV replication (serum HBeAg-positive and positive for serum HBV DNA) and persistently elevated ALT levels and/or chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis.

The results of these trials are summarized below. Trial 1 was a randomized, double-blind trial of lamivudine tablets (HBV) 100 mg once daily versus placebo for 52 weeks followed by a 16-week no-treatment period in 141 treatment-naive U.S. subjects. Trial 2 was a randomized, double-blind, 3-arm trial that compared lamivudine tablets (HBV) 25 mg once daily versus lamivudine tablets (HBV) 100 mg once daily versus placebo for 52 weeks in 358 Asian subjects.

Trial 3 was a randomized, partially-blind trial conducted primarily in North America and Europe in 238 subjects who had ongoing evidence of active chronic hepatitis B despite previous treatment with interferon alfa. The trial compared lamivudine tablets (HBV) 100 mg once daily for 52 weeks, followed by either lamivudine tablets (HBV) 100 mg or matching placebo once daily for 16 weeks (Arm 1), versus placebo once daily for 68 weeks (Arm 2). Principal endpoint comparisons for the histologic and serologic outcomes in subjects receiving lamivudine tablets (HBV) (100 mg daily) or placebo in these trials are shown in the following tables.

Table 7. His t ologic Re sponse at W ee k 52 a mo ng A dult S ub ject s Rece iving Lamivudine Tablets (HBV) 100 mg Once Daily or Placebo A ssessment Trial 1 Trial 2 Trial 3 Lamivudine Tablets (HBV) (n = 62) Placebo (n = 63) Lamivudine Tablets (HBV) (n = 131) Placebo (n = 68) Lamivudine Tablets (HBV) (n = 110) Placebo (n = 54) Improvement a 55% 25% 56% 26% 56% 26% No Improvement 27% 59% 36% 62% 25% 54% Missing Data 18% 16% 8% 12% 19% 20% a Improvement was defined as a greater than or equal to 2-point decrease in the Knodell Histologic Activity Index (HAI) at Week 52 compared with pretreatment HAI.

Subjects with missing data at baseline were excluded. Table 8. HBeAg Seroconverters a at Week 52 among Adult Subjects Receiving Lamivudine Tablets (HBV) 100 mg Once Daily or Placebo Seroconversion Trial 1 Trial 2 Trial 3 Lamivudine Tablets (HBV) (n = 63) Placebo (n = 69) Lamivudine Tablets (HBV) (n = 140) Placebo (n = 70) Lamivudine Tablets (HBV) (n = 108) Placebo (n = 53) Seroconverters 17% 6% 16% 4% 15% 13% a Three-component seroconversion was defined as Week 52 values showing loss of HBeAg, gain of HBeAb, and reduction of HBV DNA to below the solution-hybridization assay limit.

Subjects with negative baseline HBeAg or HBV DNA assay were excluded from the analysis. Normalization of serum ALT levels was more frequent with treatment of lamivudine tablets (HBV) compared with placebo in Trials 1, 2, and 3. The majority of subjects treated with lamivudine tablets (HBV) showed a decrease of HBV DNA to below the assay limit early in the course of therapy.

However, reappearance of assay-detectable HBV DNA during treatment with lamivudine tablets (HBV) was observed in approximately one-third of subjects after this initial response.

14.2Pediatric Subjects The safety and efficacy of lamivudine tablets (HBV) were evaluated in a double-blind clinical trial in 286 subjects aged 2 to 17 years, who were randomized (2:1) to receive 52 weeks of lamivudine tablets (HBV) (3 mg per kg once daily to a maximum of 100 mg once daily) or placebo. All subjects had compensated chronic hepatitis B accompanied by evidence of hepatitis B virus replication (positive serum HBeAg and positive for serum HBV DNA by a research branched-chain DNA assay) and persistently elevated serum ALT levels.

The combinati… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 171 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term carcinogenicity studies with lamivudine in mice and rats showed no evidence of carcinogenic potential at exposures up to 34 times (mice), and 113 and 187 times (male and female rats, respectively) those observed in humans at the recommended therapeutic dose for chronic hepatitis B. Mutagenesis Lamivudine was mutagenic in an L5178Y mouse lymphoma assay and clastogenic in a cytogenetic assay using cultured human lymphocytes. Lamivudine was not mutagenic in a microbial mutagenicity assay, in an in vitro cell transformation assay, in a rat micronucleus test, in a rat bone marrow cytogenetic assay, and in an assay for unscheduled DNA synthesis in rat liver.

Impairment of Fertility Lamivudine did not affect male or female fertility in rats at oral doses up to 4,000 mg per kg per day, associated with concentrations approximately 70 times (male) or 104 times (females) higher than the concentrations (C max ) in humans at the dose of 100 mg [see Use in Specific Populations ( 8.1)].

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 168 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term carcinogenicity studies with lamivudine in mice and rats showed no evidence of carcinogenic potential at exposures up to 34 times (mice), and 113 and 187 times (male and female rats, respectively) those observed in humans at the recommended therapeutic dose for chronic hepatitis B. Mutagenesis Lamivudine was mutagenic in an L5178Y mouse lymphoma assay and clastogenic in a cytogenetic assay using cultured human lymphocytes. Lamivudine was not mutagenic in a microbial mutagenicity assay, in an in vitro cell transformation assay, in a rat micronucleus test, in a rat bone marrow cytogenetic assay, and in an assay for unscheduled DNA synthesis in rat liver.

Impairment of Fertility Lamivudine did not affect male or female fertility in rats at oral doses up to 4,000 mg per kg per day, associated with concentrations approximately 70 times (male) or 104 times (females) higher than the concentrations (C max ) in humans at the dose of 100 mg [see Use in Specific Populations ( 8.1)].

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ PATIENT INFORMATION Lamivudine Tablets (HBV) (la miv′ ue deen) What is the most important information I should know about lamivudine tablets (HBV)? Lamivudine tablets (HBV) can cause serious side effects, including: • Worsening liver disease. Your hepatitis B infection may become worse after stopping treatment with lamivudine tablets (HBV).

Worsening liver disease can be serious and may lead to death. If you stop treatment with lamivudine tablets (HBV), your healthcare provider will need to check your health and do blood tests to check your liver for at least several months after you stop taking lamivudine tablets (HBV). • Risk of HIV-1 resistance in people with unknown HIV-1 infection or in people with untreated HIV-1 infection. If you have or get HIV-1 (Human Immunodeficiency Virus type 1) that is not being treated with medicines while taking lamivudine tablets HBV, the HIV-1 virus may develop resistance to certain HIV-1 medicines and become harder to treat.

Your healthcare provider should offer you counseling and testing for HIV-1 infection before you start treatment for hepatitis B with lamivudine tablets (HBV) and during treatment. Lamivudine tablets (HBV) contain a lower dose of lamivudine than other medicines that contain lamivudine and are used to treat HIV-1 infection. • Resistant Hepatitis B Virus (HBV). The hepatitis B virus can change (mutate) during your treatment with lamivudine tablets (HBV) and become harder to treat (resistant).

If this happens, your liver disease can become worse and may lead to death. Tell your healthcare provider right away if you have any new symptoms. • For more information about side effects, see “What are the possible side effects of lamivudine tablets (HBV)?” What are lamivudine tablets (HBV)? Lamivudine tablet (HBV) is a prescription medicine used to treat long-term (chronic) hepatitis B virus (HBV) when the disease is progressing and there is liver swelling (inflammation).

It is not known if lamivudine tablets (HBV) is safe and effective in: • people with chronic HBV who have a severely damaged liver that is unable to work properly (decompensated liver disease) • people with HIV-1, hepatitis C virus, or hepatitis D (delta) virus • people who have had a liver transplant • children with chronic HBV less than 2 years of age Lamivudine tablets (HBV) does not stop you from spreading HBV to others by sex, sharing needles, or being exposed to your blood. Avoid doing things that can spread HBV infection to others.

Do not take lamivudine tablets (HBV): • if you are allergic to lamivudine or any of the ingredients in lamivudine tablets (HBV). See the end of this Patient Information leaflet for a complete list of ingredients in lamivudine tablets (HBV). Before taking lamivudine tablets (HBV), tell your healthcare provider about all of your medical conditions, including if you: • have HIV-1 infection • have kidney problems • are pregnant or plan to become pregnant.

It is not known if lamivudine tablets (HBV) will harm your unborn baby. Pregnancy Registry. There is a pregnancy registry for women who take antiviral medicines during pregnancy.

The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry. • are breastfeeding or plan to breastfeed. Lamivudine can pass into your breast milk and may harm your baby.

You and your healthcare provider should decide if you will take lamivudine tablets (HBV) or breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with lamivudine tablets (HBV).

Keep a list of your medicines to show your healthcare provider and pharmacist. • You can ask your healthca… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 23 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Lamivudine Tablets (HBV) 100 mg 60 count- Container Label Lamivudine Tablets (HBV) 100 mg - Blister Carton lamivudine60containerlabel lamivudine100mgblistercarton

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 Lamivudine — the program that covers self-administered drugs. 6 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Lamivudine. 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
$519.5K
Claims incl. refills
5K
Beneficiaries
2.4K
Spend / beneficiary
$212.82
Spend / claim
$104.46
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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Lamivudine — the ingredient across all brands.

Top reported reactions

Foetal Exposure During Pregnancy2,600
Virologic Failure2,097
Drug Interaction1,996
Drug Resistance1,988
Pathogen Resistance1,962
Viral Mutation Identified1,847
Pain1,764

Age at onset

Neonate459
Infant222
Child102
Adolescent38
Adult4,805
Elderly545

Reporter sex

42,329 reports
Male · 62%
Female · 38%
Unknown · 1%

Serious outcomes

Hospitalization10,681
Death4,501
Life-threatening1,673
Disabling749
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,365 502
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 Camber Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 10 tablets (31722-0752-31), 60 tablets (31722-0752-60), 600 tablets (31722-0752-06). 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?
Camber Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 31722-0749-01 · Camber 31722-0753-06 · Camber →
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.