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Entecavir .5 mg Tablet, Film Coated, 100-count — NDC 70771-1019-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Entecavir .5 mg Tablet, Film Coated, 100-count — NDC 70771-1019-1 (Billing 70771-1019-01)

by Zydus Lifesciences Limited · 100 TABLET, FILM COATED in 1 BOTTLE

This is a package of 100 tablets of Entecavir .5 mg Tablet, Film Coated from Zydus Lifesciences Limited, marketed since Aug 2017 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.

NDC 70771-1019-01
🏷️ FDA NDC (as labeled) 70771-1019-1 billing pads the package segment with a zero
This package
Contains100-count Pack sizes4 compare ↓
Also priced by: Part D plans $1.76/unit — full pricing hub ↓
Main listing for product 70771-1019 · Also comes in: 10 tablets 70771-1019-4 30 tablets 70771-1019-3 90 tablets 70771-1019-9
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

⚠️
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) 70771-1019-1
Product NDC 70771-1019
11-digit billing NDC 70771101901
RxCUI 485434, 485436
UNII 5968Y6H45M
Application # ANDA206745
SPL Set ID 0e3b2a0a-9076-4907-bbaf-eb6a65bb9481
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 2017-08-10
Route ORAL
Dosage form TABLET, FILM COATED
Substance ENTECAVIR
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 485434
Why two NDCs? The FDA registers this code as 70771-1019-1 — a 5-4-1 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 package segment → 70771-1019-01. 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 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor class.

Pharmacologic class 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

📖 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 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 $1.76 $175.79 / 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 Marketing startMarketing endStatus
70771-1019-01 You're viewing this Main listing 100 TABLET, FILM COATED in 1 BOTTLE 2017-08-10 — Active
70771-1019-03 70771-1019-3 30 TABLET, FILM COATED in 1 BOTTLE 2017-08-10 — Active
70771-1019-04 70771-1019-4 10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK 2017-08-10 — Active
70771-1019-09 70771-1019-9 90 TABLET, FILM COATED in 1 BOTTLE 2017-08-10 — Active

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet, film coated in 1 bottle.
How does this package differ from NDC 70771-1019-03?
Both are Entecavir .5 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 100-count one, while NDC 70771-1019-03 is the 30 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.

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 mg 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 —
Baraclude .5 mg 00003-1611-12 E.R. 30 tablets $44.187 AB Availability likely —
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 mgthis 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

🏛️
2017
On the market since
Aug 2017
📍
2026
Currently FDA-listed
9 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 White / Pink
ShapeRound
Imprint921
Size1 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.

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

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA206745 (ANDA)
Labeler code70771
First marketedAug 2017
Product typeHuman Prescription Drug
Portfolio720 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. Jump with a chip, search within the label, or expand everything.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel 30 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1019-3 Entecavir Tablets USP, 0.5 mg Rx Only 30 tablets NDC 70771-1020-3 Entecavir Tablets USP, 1 mg Rx Only 30 tablets Entecavir tablets Entecavir tablets

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.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Zydus Lifesciences 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 3 other package presentations of this same product, including 10 tablets (70771-1019-04), 30 tablets (70771-1019-03), 90 tablets (70771-1019-09). 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?
Zydus Lifesciences 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.
← 70771-1018-01 · Zydus 70771-1020-01 · Zydus →
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.