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Hydroxychloroquine Sulfate 200 mg Tablet, 60-count — NDC 53401-040-53 (Billing 53401-0040-53)

by Aphena Pharma Solutions - Tennessee, LLC · 60 TABLET in 1 BOTTLE

This is a package of 60 tablets of Hydroxychloroquine Sulfate 200 mg Tablet from Aphena Pharma Solutions - Tennessee, LLC, marketed since May 2025 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.

NDC 53401-0040-53
🏷️ FDA NDC (as labeled) 53401-040-53 billing pads the product segment with a zero
This package
Contains60-count Pack sizes4 compare ↓
Main listing for product 53401-040 · Also comes in: 90 tablets 53401-040-60 120 tablets 53401-040-70 180 tablets 53401-040-80
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 53401-040-53 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
53401 labeler · 040 product · 53 package
Package marketed since
Sep 28, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5340104053 4
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53401-040-53
Product NDC 53401-040
11-digit billing NDC 53401004053
Application # ANDA040150
SPL Set ID 5ca218be-a1de-5471-e063-6394a90a97da
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 2025-05-08
Route ORAL
Dosage form TABLET
Substance HYDROXYCHLOROQUINE SULFATE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 53401-040-53 — 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 → 53401-0040-53. 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

📗 Our plain-language guide HelloPharmacist
  • Hydroxychloroquine treats and prevents malaria, and treats rheumatoid arthritis, systemic lupus and chronic discoid lupus in adults. Your prescriber chose it for your specific cond...
  • Take it by mouth with food or milk, and swallow the tablet without crushing it. For lupus or arthritis it is usually daily. For malaria prevention it is weekly on the same day, sta...
  • Stomach upset is the most common, including nausea, vomiting, diarrhea and belly pain. Taking it with food can help. Call us if side effects are severe or don't settle.
  • Yes. Hydroxychloroquine can cause permanent retinal damage, especially with higher doses, longer use or kidney problems. A baseline eye exam in the first year is recommended, then...
📖 Read our full Hydroxychloroquine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 90 tablets 120 tablets 180 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
53401-0040-53 You're viewing this Main listing 60 TABLET in 1 BOTTLE 2026-09-28 — Active
53401-0040-60 53401-040-60 90 TABLET in 1 BOTTLE 2026-09-28 — Active
53401-0040-70 53401-040-70 120 TABLET in 1 BOTTLE 2026-09-28 — Active
53401-0040-80 53401-040-80 180 TABLET in 1 BOTTLE 2026-09-28 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 tablet in 1 bottle.
How does this package differ from NDC 53401-0040-60?
Both are Hydroxychloroquine Sulfate 200 mg Tablet — the drug itself is identical. This page's package is the 60-count one, while NDC 53401-0040-60 is the 90 tablets package.
What NDC number is used to bill for this package of Hydroxychloroquine Sulfate 200 mg Tablet?
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
Hydroxychloroquine sulfate 200 mg 68382-0096-01 Zydus 100 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 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 83980-0001-01 Ipca 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 16729-0485-01 Accord 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 59651-0889-01 Aurobindo 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 00093-2401-01 Teva 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 50268-0412-15 AvPAK 50 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 57664-0761-13 Sun 500 tablets $0.176 AB FDA listed —
Plaquenil 200 mg 71205-0448-12 Proficient 12 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 71610-0506-30 Aphena 30 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 50090-6280-01 A-S 60 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71610-0701-53 Aphena 60 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 50090-6629-00 A-S 90 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 60219-1544-01 Amneal 100 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 68788-7747-02 Preferred 20 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 42385-0971-01 Laurus 100 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 50090-7307-00 A-S 90 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 55154-3567-00 Cardinal 10 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-2813-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-3113-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 50090-5573-00 A-S 30 tablets — AB Discontinued —
Hydroxychloroquine Sulfate 200 mg 67046-1523-03 Coupler 30 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-3079-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 50090-4659-01 A-S 60 tablets — AB Discontinued —
Plaquenil 200 mg 59212-0562-10 Advanz 100 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 65841-0633-01 Zydus 100 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 68071-2332-01 NuCare 100 tablets — AB FDA listed —
Sovuna 200 mg 70954-0804-10 ANI 30 tablets — — FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-2814-01 Bryant 500 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 82619-0131-01 Creekwood 100 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 50090-7306-01 A-S 60 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 55154-2074-00 Cardinal 1 tablet — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 00615-8459-39 NCS 30 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 71335-0897-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-1771-01 Bryant 100 tablets — AB FDA listed —
Plaquenil 200 mg 71610-0473-30 Aphena 30 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-1523-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 72162-2467-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 68071-3955-06 NuCare 60 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-3142-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71610-0961-30 Aphena 30 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 76420-0850-01 Asclemed 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mgthis 53401-0040-53 Aphena 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

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year 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 Hydroxychloroquine 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

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderCREEKWOOD PHARMACEUTICALS LLC
FDA applicationANDA040150 (ANDA)
Labeler code53401
First marketedMay 2025
Product typeHuman Prescription Drug
Portfolio801 products on file

More NDCs from Aphena Pharma Solutions - Tennessee, LLC labeler code 53401

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 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.

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 — Not published for this NDC No photo available yet for this listing.
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 Aphena Pharma Solutions - Tennessee, LLC. 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 90 tablets (53401-0040-60), 120 tablets (53401-0040-70), 180 tablets (53401-0040-80). 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?
Aphena Pharma Solutions - Tennessee, LLC 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.
← 53401-0039-53 · Aphena 53405-0008-01 · InLight →
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.