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Entecavir .5 mg Tablet, Film Coated, 30-count — NDC 69097-426-02 (Billing 69097-0426-02)

by Cipla USA Inc. · 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

This is a package of 30 tablets of Entecavir .5 mg Tablet, Film Coated from Cipla USA Inc., marketed since Dec 2016 and currently FDA-listed; retail pharmacies pay about $0.2186 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 69097-0426-02
🏷️ FDA NDC (as labeled) 69097-426-02 billing pads the product segment with a zero
This package
Contains30-count Cost per ea$0.2186 NADAC Per package$6.56 / 30 tablets Pack sizes2 compare ↓
Also priced by: Part D plans $1.76/unit — full pricing hub ↓
Main listing for product 69097-426 · Also comes in: 90 tablets 69097-426-05
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 69097-426-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
69097 labeler · 426 product · 02 package
Package marketed since
Dec 6, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
30 EA per package
Barcode (UPC-A, from the NDC)
3 6909742602 6
FDA record last changed
Oct 8, 2026
⚠️
Other active recalls for Entecavir (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 24, 2025 — Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0001-2026
Class II · Sep 24, 2025 — Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0002-2026
Class II · Sep 4, 2025 — Failed Impurity/Degradation Specifications (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0657-2025
Class II · Sep 4, 2025 — Failed Impurity/Degradation Specifications (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0656-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69097-426-02
Product NDC 69097-426
11-digit billing NDC 69097042602
NCPDP billing unit EA — each (per item)
Application # ANDA206872
SPL Set ID 6766d9ae-3639-4bc7-9488-5bf52fe49420
Established class (EPC) Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of action Nucleoside Reverse Transcriptase Inhibitors
Chemical class Nucleoside Analog
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-12-06
Route ORAL
Dosage form TABLET, FILM COATED
Substance ENTECAVIR
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 058934
GCN 24466
HICL code 032832
Ingredient (HICL) Entecavir
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 08:18.32.00
AHFS class Nucleoside And Nucleotide Antivirals
FDB label name ENTECAVIR 0.5 MG TABLET
FDB brand name Entecavir
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 058934
  • GCN: 24466
  • HICL (First Databank): 032832
  • AHFS class code: 08:18.32.00
Why two NDCs? The FDA registers this code as 69097-426-02 — 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 → 69097-0426-02. 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.

Clinical

Label name ENTECAVIR 0.5 MG TABLET Ingredient Entecavir
📖 What it is MedlinePlus · NLM

Entecavir is used to treat chronic (long-term) hepatitis B infection (swelling of the liver caused by a virus) in adults and children 2 years of age and older who have liver damage. Entecavir is in a class of medications called nucleoside analogs. It works by decreasing the amount of hepatitis B virus (HBV) in the body. Entecavir does not cure HBV and may not prevent complications of chronic hepatitis B such as cirrhosis of the liver or liver cancer. Entecavir does not prevent the spread of HBV to other people.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Entecavir keeps the hepatitis B virus under control by stopping it from copying itself, which protects your liver from ongoing damage. It's not a cure — it doesn't permanently clea...
  • What exactly is entecavir treating — is it curing my hepatitis B?
  • Yes, timing really does matter here. You need to take entecavir on an empty stomach — at least 2 hours after eating and at least 2 hours before your next meal. Studies showed that...
  • Does it matter when I take it — can I take it with breakfast?
📖 Read our full Entecavir 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 eaPer package
Retail pharmacies payNADAC · weekly $0.219 $6.56 / 30 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1.76 $52.74 / 30 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $1.100 $0.210
▼ Down 80% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
69097-0426-02 You're viewing this Main listing 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC $0.2186 / ea $6.56 2016-12-06 — Active
69097-0426-05 69097-426-05 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC — — 2016-12-06 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 tablet, film coated in 1 bottle, plastic.
How does this package differ from NDC 69097-0426-05?
Both are Entecavir .5 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 30-count one, while NDC 69097-0426-05 is the 90 tablets package.
What NDC number is used to bill for this package of Entecavir .5 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
Entecavir .5 mg 16714-0717-01 NorthStar 30 tablets $0.219 AB Availability likely —
Entecavir .5 mg 31722-0833-30 Camber 30 tablets $0.219 AB Availability likely —
Entecavir .5 mg 42494-0457-30 Cameron 30 tablets $0.219 AB Availability likely —
Entecavir .5 mg 42806-0658-30 EPIC 30 tablets $0.219 AB Availability likely —
Entecavir .5 mg 42806-0667-30 Epic 30 tablets $0.219 AB Availability likely —
Entecavir .5 mg 43547-0436-03 Solco 30 tablets $0.219 — Availability likely —
Entecavir .5 mg 60687-0216-25 American 30 tablets $0.219 AB Availability likely —
Entecavir .5 mg 61442-0311-30 Carlsbad 30 tablets $0.219 AB Availability likely —
Entecavir .5 mg 65862-0841-30 Aurobindo 30 tablets $0.219 AB Availability likely —
Entecavir .5 mgthis 69097-0426-02 Cipla 30 tablets $0.219 AB Availability likely —
Entecavir .5 mg 65162-0446-03 Amneal 30 tablets $1.077 AB FDA listed +393%
Baraclude .5 mg 00003-1611-12 E.R. 30 tablets $44.187 AB Availability likely +20116%
Entecavir .5 mg 42291-0261-30 AvKARE 30 tablets — AB FDA listed —
Entecavir .5 mg 50771-0013-01 Yaopharma 30 tablets — — FDA listed —
Entecavir .5 mg 51407-0589-30 Golden 30 tablets — AB FDA listed —
Entecavir .5 mg 68382-0920-01 Zydus 100 tablets — AB FDA listed —
Entecavir .5 mg 70771-1019-01 Zydus 100 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

🏛️
2016
On the market since
Dec 2016
📍
2026
Currently FDA-listed
10 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.

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 Entecavir 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerCipla USA Inc.
Application holderCIPLA LTD
FDA applicationANDA206872 (ANDA)
Labeler code69097
First marketedDec 2016
Product typeHuman Prescription Drug
Portfolio222 products on file

More NDCs from Cipla USA Inc. labeler code 69097

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. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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 Entecavir — the program that covers self-administered drugs. 9 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 Entecavir. 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
$5.68M
Claims incl. refills
43K
Beneficiaries
24K
Spend / beneficiary
$236.22
Spend / claim
$131.95
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 Entecavir — the ingredient across all brands.

Top reported reactions

Death551
Drug Resistance402
Diarrhoea376
Pyrexia365
Fatigue363
Hepatitis B329
Nausea325

Age at onset

Neonate12
Infant5
Child13
Adolescent7
Adult1,361
Elderly881

Reporter sex

11,608 reports

Serious outcomes

Hospitalization4,431
Death1,880
Life-threatening578
Disabling196
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 858 343
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.
← 69097-0425-02 · Cipla 69097-0429-67 · Cipla →
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.