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Haloperidol 10 mg Tablet, 100-count — NDC 65841-0627-01 package photo

Haloperidol 10 mg Tablet, 100-count

by Zydus Lifesciences Limited · 100 TABLET in 1 BOTTLE (65841-627-01)
NDC 65841-0627-01
🏷️ FDA NDC (as labeled) 65841-627-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.2329/unit — full pricing hub ↓
Also comes in: 1000 tablets 65841-0627-10
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) 65841-627-01
Product NDC 65841-627
11-digit billing NDC 65841062701
RxCUI 197754, 310670, 310671, 310672, 314034, 314035
UNII J6292F8L3D
Application # ANDA077580
SPL Set ID 509d0eb2-b930-4836-9669-dbebf0ac4076
Established class (EPC) Typical Antipsychotic
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
Substance HALOPERIDOL
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 65841-627-01 — 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 → 65841-0627-01. 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 Typical Antipsychotic class.

Pharmacologic class Typical Antipsychotic
Drug family (ATC) Butyrophenone derivatives
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 applicationANDA077580 (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

📖 What it is MedlinePlus · NLM

Haloperidol is used to manage psychotic disorders (mental illness that cause disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). It is also used to control motor tics (uncontrollable need to repeat certain body movements) and verbal tics (uncontrollable need to repeat sounds or words) in people who have Tourette's disorder (condition characterized by motor or verbal tics). Haloperidol is in a group of medications called antipsychotics. It works by changing the activity of certain natural substances.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Haloperidol is mainly used to manage symptoms of psychotic disorders — things like hallucinations and severely disorganized thinking. It's also used to control the tics and vocal s...
  • The most common things people notice early on are muscle stiffness, tremors, or a restless, can't-sit-still feeling. Some people also feel drowsy or notice their blood pressure dip...
  • What side effects should I watch out for when I first start taking it?
  • Yes — a few things need prompt attention. If you develop sudden muscle spasms in your neck or jaw, throat tightening, or trouble swallowing or breathing, get help right away. Also...
📖 Read our full Haloperidol 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.

💊 What it looks like

Color Green / Orange / White / Pink
ShapeRound
Imprint15;13
Size7 mm
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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII 776XM7047L
    Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • 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 J9EQA3S2JM
    FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • 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.

8 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 $0.2329 $23.29 / 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Haloperidol 10 mg 00378-0334-01 Mylan 100 tablets $0.140 AB Discontinued —
Haloperidol 10 mg 00832-1550-01 Upsher-Smith 100 tablets $0.140 AB Availability likely —
Haloperidol 10 mg 00904-6733-61 Major 100 tablets $0.140 AB Availability likely —
Haloperidol 10 mg 11788-0075-01 AiPing 100 tablets $0.140 AB Availability likely —
Haloperidol 10 mg 58657-0704-01 Method 100 tablets $0.140 AB Availability likely —
Haloperidol 10 mg 58657-0904-01 Method 100 tablets $0.140 AB Availability likely —
Haloperidol 10 mg 59651-0793-01 Aurobindo 100 tablets $0.140 AB Availability likely —
Haloperidol 10 mg 68084-0249-01 American 100 tablets $0.140 AB Availability likely —
Haloperidol 10 mg 68382-0080-01 Zydus 100 tablets $0.140 AB Availability likely —
Haloperidol 10 mg 69292-0588-01 Amici 100 tablets $0.140 AB Availability likely —
Haloperidol 10 mg 70756-0242-11 Lifestar 100 tablets $0.140 AB Availability likely —
Haloperidol 10 mg 71247-0154-01 Innogenix, 100 tablets $0.169 AB FDA listed —
Haloperidol 10 mg 00615-8627-39 NCS 30 tablets — AB FDA listed —
Haloperidol 10 mg 10135-0756-01 Marlex 100 tablets — AB FDA listed —
Haloperidol 10 mg 63629-2326-01 Bryant 100 tablets — AB FDA listed —
Haloperidol 10 mgthis 65841-0627-01 Zydus 100 tablets — AB FDA listed —
Haloperidol 10 mg 67046-0838-03 Coupler 30 tablets — AB FDA listed —
Haloperidol 10 mg 70518-1599-00 REMEDYREPACK 30 tablets — AB FDA listed —
Haloperidol 10 mg 70518-3587-00 REMEDYREPACK 30 tablets — AB FDA listed —
Haloperidol 10 mg 72162-1687-01 Bryant 100 tablets — AB FDA listed —
Haloperidol 10 mg 72162-2625-01 Bryant 100 tablets — AB FDA listed —
Haloperidol 10 mg 72205-0068-91 Novadoz 100 tablets — AB FDA listed —
Haloperidol 10 mg 72789-0559-01 PD-Rx 100 tablets — AB FDA listed —
Haloperidol 10 mg 82619-0109-01 Creekwood 30 tablets — AB FDA listed —
Haloperidol 10 mg 70518-4725-00 REMEDYREPACK 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 Haloperidol — the program that covers self-administered drugs. 13 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 Haloperidol. 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
$5.14M
Claims incl. refills
223.5K
Beneficiaries
82.3K
Spend / beneficiary
$62.40
Spend / claim
$22.99
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
65841-0627-01 You're viewing this 100 TABLET in 1 BOTTLE (65841-627-01) 2008-01-03 Active
65841-0627-10 1000 TABLET in 1 BOTTLE (65841-627-10) 2008-01-03 Active

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

Pack size FAQ

What quantity is in NDC 65841-0627-01?
NDC 65841-0627-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 65841-0627-01 and NDC 65841-0627-10?
Both are Haloperidol 10 mg Tablet — the drug itself is identical. NDC 65841-0627-01 is the 100-count package, while NDC 65841-0627-10 is the 1000 tablets package.
What NDC number is used to bill for this package of Haloperidol 10 mg Tablet?
Bill NDC 65841-0627-01 — the 11-digit billing format is 65841062701. 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 65841-627-01, 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: 65841-0627-01, written without dashes as 65841062701. 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 65841-0627-01, the first segment (65841) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (0627) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 1 other package presentation of this same product, including 1000 tablets (65841-0627-10). 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.
📄 FDA label
📄 FDA label 9 words ▾

No readable label sections were found for this product.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65841-0626-01 · Zydus 65841-0628-01 · 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.