Hydroxychloroquine sulfate 200 mg Tablet, Film Coated, 500-count
by Zydus Lifesciences Limited · 500 TABLET, FILM COATED in 1 BOTTLE (65841-633-05)
NDC 65841-0633-05
🏷️ FDA NDC (as labeled)
65841-633-05
billing pads the product segment with a zero
This package
Contains500-count
Pack sizes3 compare ↓
Also priced by: Part D plans $0.3275/unit — full pricing hub ↓
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 →
🆔 Identity & classification
FDA NDC (as labeled)
65841-633-05
Product NDC
65841-633
11-digit billing NDC
65841063305
RxCUI
979092
UNII
8Q2869CNVH
Application #
ANDA040657
SPL Set ID
1aa44bff-9a62-48b4-a520-98d7d524e3a9
Established class (EPC)
Antimalarial; Antirheumatic Agent
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2008-01-03
Route
ORAL
Dosage form
TABLET, FILM COATED
Substance
HYDROXYCHLOROQUINE SULFATE
TE code (Orange Book)
AB · RLD · RS
Why two NDCs?
The FDA registers this code as 65841-633-05 — 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 → 65841-0633-05. 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 Antimalarial class.
Pharmacologic class
Antimalarial, Antirheumatic Agent
Drug family (ATC)
Aminoquinolines
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 applicationANDA040657 (ANDA)
Labeler code65841
First marketedJan 2008
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
📗 Our plain-language guide HelloPharmacist
- It has two main uses. First, it treats and helps prevent malaria — a parasitic infection spread by mosquitoes — in both adults and children. Second, it helps manage autoimmune cond...
- What exactly is hydroxychloroquine used for?
- Always take it by mouth with food or milk — this helps protect your stomach and reduces nausea. Don't crush or split the tablet unless your specific product allows it; check your l...
- How should I take my hydroxychloroquine tablet?
Patient education
Supplement & herbal interactions
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.
💬 Questions about Hydroxychloroquine sulfate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
White
ShapeOval
ImprintZC38
Size13 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII O7TSZ97GEP
A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together 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 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 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
-
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
-
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
-
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.
7 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 system | Per each | Per 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 | $0.3275 | $163.75 / 500 tablets |
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydroxychloroquine Sulfate 200 mg 00093-2401-01 | Teva | 100 tablets | $0.149 | AB | Availability likely | — |
| Hydroxychloroquine Sulfate 200 mg 00904-7046-06 | Major | 50 tablets | $0.149 | AB | Availability likely | — |
| Hydroxychloroquine Sulfate 200 mg 16571-0112-01 | Rising | 100 tablets | $0.149 | AB | Availability likely | — |
| Hydroxychloroquine sulfate 200 mg 16714-0110-01 | Northstar | 100 tablets | $0.149 | AB | Availability likely | — |
| Hydroxychloroquine Sulfate 200 mg 16729-0485-01 | Accord | 100 tablets | $0.149 | AB | Availability likely | — |
| Hydroxychloroquine Sulfate 200 mg 43598-0721-01 | Dr. | 100 tablets | $0.149 | AB | Availability likely | — |
| Hydroxychloroquine Sulfate 200 mg 50268-0412-15 | AvPAK | 50 tablets | $0.149 | AB | Availability likely | — |
| Hydroxychloroquine Sulfate 200 mg 59651-0889-01 | Aurobindo | 100 tablets | $0.149 | AB | Availability likely | — |
| Hydroxychloroquine 200 mg 62135-0752-90 | Chartwell | 90 tablets | $0.149 | AB | Availability likely | — |
| Hydroxychloroquine Sulfate 200 mg 68084-0269-01 | American | 1 tablet | $0.149 | AB | Availability likely | — |
| Hydroxychloroquine sulfate 200 mg 68382-0096-01 | Zydus | 100 tablets | $0.149 | AB | Availability likely | — |
| Hydroxychloroquine Sulfate 200 mg 69238-1544-01 | Amneal | 100 tablets | $0.149 | AB | Availability likely | — |
| Hydroxychloroquine sulfate 200 mg 82009-0045-05 | Quallent | 500 tablets | $0.149 | AB | Availability likely | — |
| Hydroxychloroquine Sulfate 200 mg 83980-0001-01 | Ipca | 100 tablets | $0.149 | AB | Availability likely | — |
| Hydroxychloroquine sulfate 200 mg 57664-0761-13 | Sun | 500 tablets | $0.176 | AB | FDA listed | — |
| Hydroxychloroquine sulfate 200 mg 00615-8459-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine Sulfate 200 mg 42385-0971-01 | Laurus | 100 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine Sulfate 200 mg 50090-4659-01 | A-S | 60 tablets | — | AB | Discontinued | — |
| Hydroxychloroquine sulfate 200 mg 50090-5573-00 | A-S | 30 tablets | — | AB | Discontinued | — |
| Hydroxychloroquine Sulfate 200 mg 50090-6280-01 | A-S | 60 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine sulfate 200 mg 50090-6629-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine sulfate 200 mg 50090-7306-01 | A-S | 60 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine sulfate 200 mg 50090-7307-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine sulfate 200 mg 55154-2074-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Hydroxychloroquine Sulfate 200 mg 55154-3567-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Plaquenil 200 mg 59212-0562-10 | Advanz | 100 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine Sulfate 200 mg 60219-1544-01 | Amneal | 100 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine sulfate 200 mgthis 65841-0633-05 | Zydus | 500 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine Sulfate 200 mg 67046-1523-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine sulfate 200 mg 68071-2332-01 | NuCare | 100 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine sulfate 200 mg 68071-3955-06 | NuCare | 60 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine sulfate 200 mg 68788-7747-02 | Preferred | 20 tablets | — | AB | FDA listed | — |
| Sovuna 200 mg 70954-0804-10 | ANI | 30 tablets | — | — | FDA listed | — |
| Plaquenil 200 mg 71205-0448-12 | Proficient | 12 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine sulfate 200 mg 71335-0897-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine Sulfate 200 mg 71335-1523-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine Sulfate 200 mg 71335-1771-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine Sulfate 200 mg 71335-2813-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine Sulfate 200 mg 71335-2814-01 | Bryant | 500 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine Sulfate 200 mg 71335-3079-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine Sulfate 200 mg 71335-3113-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine Sulfate 200 mg 71335-3142-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Plaquenil 200 mg 71610-0473-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine sulfate 200 mg 71610-0506-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine Sulfate 200 mg 71610-0701-53 | Aphena | 60 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine Sulfate 200 mg 71610-0961-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine Sulfate 200 mg 72162-2467-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine sulfate 200 mg 76420-0850-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Hydroxychloroquine Sulfate 200 mg 82619-0131-01 | Creekwood | 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
🏛️
2008
On the market since
Jan 2008
📍
2026
Currently FDA-listed
18 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.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Hydroxychloroquine Sulfate — the program that covers self-administered drugs. 14 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 Hydroxychloroquine Sulfate. 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
$25.3M
Claims incl. refills
636.2K
Beneficiaries
461.3K
Spend / beneficiary
$54.85
Spend / claim
$39.77
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 Hydroxychloroquine Sulfate — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 14%
Female · 86%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 65841-0633-01 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-633-01) | 2008-01-03 | Active |
| 65841-0633-05 You're viewing this | 500 TABLET, FILM COATED in 1 BOTTLE (65841-633-05) | 2008-01-03 | Active |
| 65841-0633-30 | 10 BLISTER PACK in 1 CARTON (65841-633-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 2008-01-03 | Active |
Pack size FAQ
What quantity is in NDC 65841-0633-05?
NDC 65841-0633-05 is a 500-count package — 500 tablet, film coated in 1 bottle.
What is the difference between NDC 65841-0633-05 and NDC 65841-0633-01?
Both are Hydroxychloroquine sulfate 200 mg Tablet, Film Coated — the drug itself is identical. NDC 65841-0633-05 is the 500-count package, while NDC 65841-0633-01 is the 100 tablets package.
What NDC number is used to bill for this package of Hydroxychloroquine sulfate 200 mg Tablet, Film Coated?
Bill NDC 65841-0633-05 — the 11-digit billing format is 65841063305. 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 65841-633-05, 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: 65841-0633-05, written without dashes as 65841063305. 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 65841-0633-05, the first segment (65841) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (0633) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 2 other package presentations of this same product, including 10 tablets (65841-0633-30), 100 tablets (65841-0633-01). 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.
📄 FDA label ▾
No readable label sections were found for this product.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.