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bupropion 300 mg Tablet, Extended Release, 90-count — NDC 65841-0780-16 package photo

bupropion 300 mg Tablet, Extended Release, 90-count

by Zydus Lifesciences Limited · 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-780-16)
NDC 65841-0780-16
🏷️ FDA NDC (as labeled) 65841-780-16 billing pads the product segment with a zero
This package
Contains90-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.3192/unit — full pricing hub ↓
Also comes in: 30 tablets 65841-0780-06 500 tablets 65841-0780-05 1000 tablets 65841-0780-10
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 65841-780-16
Product NDC 65841-780
11-digit billing NDC 65841078016
RxCUI 993541, 993557
UNII ZG7E5POY8O
Application # ANDA201567
SPL Set ID 78d34aad-9d4f-48c4-91eb-536e31c6b6c9
Established class (EPC) Aminoketone
Mechanism of action Dopamine Uptake Inhibitors; Norepinephrine Uptake Inhibitors
Physiologic effect Increased Dopamine Activity; Increased Norepinephrine Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-02-15
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance BUPROPION HYDROCHLORIDE
TE code (Orange Book) AB3 · RLD · RS
Why two NDCs? The FDA registers this code as 65841-780-16 — 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 → 65841-0780-16. 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 Aminoketone class.

Pharmacologic class Aminoketone
Drug family (ATC) Centrally acting antiobesity products, Other antidepressants
How it works Norepinephrine Uptake Inhibitors, Dopamine Uptake 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.

🏭 Manufacturer & labeler

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA201567 (ANDA)
Labeler code65841
First marketedFeb 2014
Product typeHuman Prescription Drug
Portfolio717 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.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Bupropion is used to treat depression. and seasonal affective disorder (SAD; episodes of depression that occur at the same time each year [usually in the fall and winter but rarely may occur in the spring or summer months]). Bupropion is also used to help people stop smoking. Bupropion is in a class of medications called antidepressants. It works by increasing certain types of activity in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Bupropion is an antidepressant primarily used to treat major depressive disorder — that's clinical depression. Depending on which formulation you're prescribed, it may also be used...
  • Most people don't notice a full effect immediately — antidepressant treatment for depression typically requires several months or longer. Your dose may also be increased gradually...
  • Will bupropion make me feel better right away?
  • The most common ones are dry mouth, nausea, trouble sleeping, dizziness, headache, and feeling anxious or agitated — especially early on. Many of these improve as your body adjusts...
📖 Read our full Bupropion guide →
1
Nutrient depletion considerations

Bupropion may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Bupropion nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Yellow
ShapeRound
Imprint353
Size8 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 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 1CS02G8656
    Methacrylic acid is a synthetic polymer used as a coating material and binder in tablets and capsules. It helps control how and where the medication releases in the digestive system.
  • 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

14 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.

💲 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 $0.3192 $28.73 / 90 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bupropion Hydrochloride XL 300 mg 00904-7469-04 Major 1 tablet $0.101 AB3 Availability likely —
bupropion hydrochloride 300 mg 16571-0863-03 Rising 30 tablets $0.101 AB3 Availability likely —
Bupropion Hydrochloride 300 mg 16729-0444-10 Accord 30 tablets $0.101 AB3 Availability likely —
Bupropion Hydrochloride 300 mg 31722-0488-05 Camber 500 tablets $0.101 AB3 Availability likely —
Bupropion Hydrochloride XL 300 mg 42806-0349-05 Epic 500 tablets $0.101 AB3 Availability likely —
Bupropion Hydrochloride XL 300 mg 42806-0416-05 Epic 500 tablets $0.101 AB3 Availability likely —
Bupropion Hydrochloride (XL) 300 mg 43598-0656-05 Dr 500 tablets $0.101 AB3 Availability likely —
Bupropion Hydrochloride 300 mg 45963-0142-05 Actavis 500 tablets $0.101 AB3 Availability likely —
Bupropion Hydrochloride (XL) 300 mg 50228-0145-05 ScieGen 500 tablets $0.101 AB3 Availability likely —
Bupropion Hydrochloride 300 mg 50268-0134-13 AvPAK 1 tablet $0.101 AB3 Availability likely —
Bupropion Hydrochloride 300 mg 60687-0793-21 American 1 tablet $0.101 AB3 Availability likely —
Bupropion hydrochloride 300 mg 68001-0614-03 BluePoint 500 tablets $0.101 AB3 Availability likely —
Bupropion Hydrochloride XL 300 mg 68180-0320-02 Lupin 500 tablets $0.101 AB3 Availability likely —
Bupropion Hydrochloride 300 mg 69097-0072-12 Cipla 500 tablets $0.101 AB3 Availability likely —
Bupropion Hydrochloride (XL) 300 mg 69097-0876-02 CIPLA 30 tablets $0.101 — Availability likely —
Bupropion Hydrochloride XL 300 mg 69367-0289-05 Westminster 500 tablets $0.101 AB3 Discontinued —
Bupropion hydrochloride 300 mg 70010-0785-03 Granules 30 tablets $0.101 AB3 Availability likely —
Bupropion Hydrochloride XL 300 mg 82009-0052-05 Quallent 500 tablets $0.101 AB3 Availability likely —
Bupropion Hydrochloride (XL) 300 mg 83301-0025-01 Mullan 30 tablets $0.101 AB3 Availability likely —
Bupropion hydrochloride 300 mg 63304-0724-05 Sun 500 tablets $0.103 — Discontinued —
Bupropion Hydrochloride 300 mg 68001-0520-03 BluePoint 500 tablets $0.107 AB3 Availability likely —
Bupropion Hydrochloride (XL) 300 mg 24979-0102-02 Upsher-Smith 500 tablets $0.112 — Discontinued —
Bupropion Hydrochloride XL 300 mg 70436-0011-02 Slate 500 tablets $0.115 AB3 Availability likely —
Bupropion hydrochloride (XL) 300 mg 00527-2430-32 Lannett 30 tablets $0.144 AB3 FDA listed —
Wellbutrin Xl 300 mg 00187-0731-07 Bausch 7 tablets — AB3 FDA listed —
Bupropion Hydrochloride 300 mg 00615-8505-05 NCS 15 tablets — AB3 FDA listed —
Bupropion Hydrochloride 300 mg 50090-4749-00 A-S 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride 300 mg 50090-5245-00 A-S 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 300 mg 50090-5334-00 A-S 30 tablets — — FDA listed —
Bupropion Hydrochloride XL 300 mg 50090-6961-00 A-S 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride XL 300 mg 50090-6962-00 A-S 90 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 300 mg 50090-7334-00 A-S 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 300 mg 50090-7335-00 A-S 90 tablets — AB3 FDA listed —
Bupropion Hydrochloride XL 300 mg 50090-7602-00 A-S 90 tablets — AB3 FDA listed —
Bupropion Hydrochloride 300 mg 55700-0820-30 Quality 30 tablets — AB3 Discontinued —
Bupropion Hydrochloride (Xl) 300 mg 62135-0876-30 Chartwell 30 tablets — AB3 FDA listed —
bupropion 300 mg 63187-0521-30 Proficient 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride 300 mg 63187-0819-30 Proficient 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 300 mg 63629-8475-01 Bryant 500 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 300 mg 63629-8476-01 Bryant 30 tablets — AB3 FDA listed —
bupropion 300 mgthis 65841-0780-16 Zydus 90 tablets — AB3 FDA listed —
Bupropion hydrochloride 300 mg 67046-1497-03 Coupler 30 tablets — AB3 FDA listed —
Bupropion hydrochloride 300 mg 67046-1648-03 Coupler 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride XL 300 mg 68071-3928-09 NuCare 90 tablets — AB3 FDA listed —
bupropion 300 mg 68382-0354-05 Zydus 500 tablets — AB3 FDA listed —
Bupropion Hydrochloride 300 mg 68788-7992-01 Preferred 100 tablets — AB3 FDA listed —
Bupropion hydrochloride 300 mg 68788-8815-01 Preferred 100 tablets — AB3 FDA listed —
Bupropion hydrochloride (XL) 300 mg 69680-0158-30 Vitruvias 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 300 mg 70518-3790-00 REMEDYREPACK 30 tablets — AB3 Discontinued —
Bupropion Hydrochloride XL 300 mg 70518-4014-00 REMEDYREPACK 90 tablets — AB3 FDA listed —
bupropion hydrochloride 300 mg 70518-4343-00 REMEDYREPACK 30 tablets — AB3 FDA listed —
Bupropion hydrochloride 300 mg 70518-4415-00 REMEDYREPACK 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride XL 300 mg 70518-4446-00 REMEDYREPACK 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride XL 300 mg 70518-4551-00 REMEDYREPACK 90 tablets — AB3 FDA listed —
Bupropion Hydrochloride 300 mg 71205-0465-30 Proficient 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 300 mg 71205-0968-30 Proficient 30 tablets — — FDA listed —
Bupropion Hydrochloride (XL) 300 mg 71335-1114-01 Bryant 30 tablets — — Discontinued —
Bupropion Hydrochloride 300 mg 71335-1214-01 Bryant 30 tablets — AB3 Discontinued —
Bupropion Hydrochloride (XL) 300 mg 71335-2312-01 Bryant 30 tablets — AB3 FDA listed —
Bupropion hydrochloride 300 mg 71335-2499-01 Bryant 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 300 mg 72162-1278-09 Bryant 90 tablets — — Discontinued —
Bupropion Hydrochloride (XL) 300 mg 72162-1527-03 Bryant 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride 300 mg 72189-0124-30 DIRECT 30 tablets — AB3 FDA listed —
Bupropion HCL ER (XL) 300 mg 72189-0539-30 Direct_RX 30 tablets — AB3 FDA listed —
buPropion Hydrochloride XL 300 mg 72516-0036-03 Oryza 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 300 mg 72789-0112-90 PD-Rx 90 tablets — — Discontinued —
Bupropion Hydrochloride (XL) 300 mg 76282-0481-05 Exelan 500 tablets — — FDA listed —
Bupropion Hydrochloride 300 mg 76420-0812-01 Asclemed 100 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 300 mg 77771-0145-05 RADHA 500 tablets — AB3 FDA listed —
Bupropion Hydrochloride XL 300 mg 80425-0468-01 Advanced 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 300 mg 80425-0539-01 Advanced 30 tablets — AB3 FDA listed —
Bupropion Hydrochloride (XL) 300 mg 82804-0013-30 Proficient 30 tablets — — FDA listed —
Bupropion Hydrochloride 300 mg 85534-0006-01 HAWAII 100 tablets — AB3 FDA listed —
Bupropion hydrochloride 300 mg 87441-0014-01 Unit 30 tablets — AB3 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
Feb 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.

🔬 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 BUPROPION — the ingredient across all brands.

Top reported reactions

Nausea11,909
Fatigue10,076
Headache10,053
Depression8,639
Dizziness7,786
Anxiety7,785
Pain6,854

Reporter sex

152,137 reports

Serious outcomes

Hospitalization34,010
Death13,503
Life-threatening4,473
Disabling3,613
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 9,619 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
65841-0780-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-780-05) 2014-02-15 Active
65841-0780-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-780-06) 2014-02-15 Active
65841-0780-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-780-10) 2014-02-15 Active
65841-0780-16 You're viewing this 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65841-780-16) 2014-02-15 Active

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

Pack size FAQ

What quantity is in NDC 65841-0780-16?
NDC 65841-0780-16 is a 90-count package — 90 tablet, extended release in 1 bottle.
What is the difference between NDC 65841-0780-16 and NDC 65841-0780-06?
Both are bupropion 300 mg Tablet, Extended Release — the drug itself is identical. NDC 65841-0780-16 is the 90-count package, while NDC 65841-0780-06 is the 30 tablets package.
What NDC number is used to bill for this package of bupropion 300 mg Tablet, Extended Release?
Bill NDC 65841-0780-16 — the 11-digit billing format is 65841078016. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 65841-780-16, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 65841-0780-16, written without dashes as 65841078016. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 65841-0780-16, the first segment (65841) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (0780) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) identifies this exact package size and type. Together they name one specific package of one specific product.
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 30 tablets (65841-0780-06), 500 tablets (65841-0780-05), 1000 tablets (65841-0780-10). 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.

📄 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.
💬 Medication Guide
💬 Medication Guide 8 words ▾

Manufactured by: Cadila Healthcare Ltd. India.

SPL MEDGUIDE

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65841-0779-01 · Zydus 65841-0781-01 · 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.