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Haloperidol decanoate 100 mg/mL Injection, 1 vial — NDC 70771-1853-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Haloperidol decanoate 100 mg/mL Injection, 1 vial — NDC 70771-1853-1 (Billing 70771-1853-01)

by Zydus Lifesciences Limited · 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE

This is a package of 1 vial of Haloperidol decanoate 100 mg/mL Injection from Zydus Lifesciences Limited, marketed since Nov 2019 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 70771-1853-01
🏷️ FDA NDC (as labeled) 70771-1853-1 billing pads the package segment with a zero
This package
Contains1 vial Pack sizes2 compare ↓
Also priced by: Part D plans $19.84/unit — full pricing hub ↓
Main listing for product 70771-1853 · Also comes in: 5 vials 70771-1853-5
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 Haloperidol Decanoate (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 2, 2025 — Lack of assurance of sterility. Bacterial contamination detected in some media fill units (Amerisource Health Services LLC) · FDA recall D-0368-2025
Class II · Apr 2, 2025 — Lack of assurance of sterility. Bacterial contamination detected in some media fill units (Amerisource Health Services LLC) · FDA recall D-0369-2025
Class II · Apr 2, 2025 — Lack of assurance of sterility. Bacterial contamination detected in some media fill units (Amerisource Health Services LLC) · FDA recall D-0367-2025
Class II · Mar 21, 2025 — Lack of Assurance of Sterility: Media fill with bacterial contamination (Somerset Therapeutics Private Limited) · FDA recall D-0356-2025
Class II · Mar 21, 2025 — Lack of Assurance of Sterility: Media fill with bacterial contamination (Somerset Therapeutics Private Limited) · FDA recall D-0358-2025
Class II · Mar 21, 2025 — Lack of Assurance of Sterility: Media fill with bacterial contamination (Somerset Therapeutics Private Limited) · FDA recall D-0355-2025
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) 70771-1853-1
Product NDC 70771-1853
11-digit billing NDC 70771185301
RxCUI 859867, 859871, 1719803, 1719862
UNII AC20PJ4101
Application # ANDA211180
SPL Set ID d21796e5-9f29-4c0a-8eed-70aeb9f0e5e9
Established class (EPC) Typical Antipsychotic
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-11-14
Route INTRAMUSCULAR
Dosage form INJECTION
Substance HALOPERIDOL DECANOATE
TE code (Orange Book) AO · RLD · RS
Quick answers
  • RxCUI (RxNorm): 859867
Why two NDCs? The FDA registers this code as 70771-1853-1 — 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 → 70771-1853-01. 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.

Clinical

📖 What it is MedlinePlus · NLM

Haloperidol injection and haloperidol extended-release injection are used to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions).  . Haloperidol is in a class of medications called conventional antipsychotics. It works by changing the activity of certain natural substances in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats schizophrenia and other psychotic disorders. The tablets and oral solution are also used for Tourette’s tics and for certain severe behavior problems in children. Your pr...
  • Tablets and oral solution are taken by mouth as your prescriber directs. Injections are given into a muscle by a healthcare provider, and Haldol Decanoate is given every 4 weeks. N...
  • Movement-related effects are the most common, such as stiffness, tremor, restlessness, or slowed movement. Headache and stomach pain can also happen. Tell us about any new movement...
  • Call for fever with severe stiffness and confusion, fainting or a racing or irregular heartbeat, seizures, or swelling and trouble breathing. These can be serious.
📖 Read our full Haloperidol 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 · Q2 2026 $19.84 $19.84 / 1 vial
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
70771-1853-01 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE 2019-11-14 — Active
70771-1853-05 70771-1853-5 5 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE 2019-11-14 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 vial — 1 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose.
How does this package differ from NDC 70771-1853-05?
Both are Haloperidol decanoate 100 mg/mL Injection — the drug itself is identical. This page's package is the 1 vial one, while NDC 70771-1853-05 is the 5 vials package.
What NDC number is used to bill for this package of Haloperidol decanoate 100 mg/mL Injection?
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
haloperidol decanoate 100 mg/mL 25021-0833-01 Sagent 10 vials $7.524 AO Availability likely —
Haloperidol Decanoate 100 mg/mL 65145-0167-10 Caplin 10 vials $7.524 AO Availability likely —
Haloperidol Decanoate 100 mg/mL 71288-0503-02 Meitheal 10 vials $7.524 AO Availability likely —
Haloperidol Decanoate 100 mg/mL 72485-0521-10 Armas 10 vials $7.524 AO Availability likely —
Haloperidol Decanoate 100 mg/mL 67457-0409-13 Mylan 5 vials $15.598 AO Availability likely —
Haloperidol Decanoate 100 mg/mL 70069-0867-05 Somerset 10 vials $15.598 AO Availability likely —
Haloperidol Decanoate 100 mg/mL 70069-0384-01 Somerset 1 vial $15.598 AO Availability likely —
Haloperidol Decanoate 100 mg/mL 00143-9296-01 Hikma 1 vial $15.598 AO Availability likely —
Haloperidol Decanoate 100 mg/mL 65145-0169-01 Caplin 1 vial $15.598 AO Availability likely —
Haloperidol decanoate 100 mg/mL 70710-1464-01 Zydus 1 vial $15.598 AO Availability likely —
Haloperidol Decanoate 100 mg/mL 71288-0504-05 Meitheal 1 vial $15.598 AO Availability likely —
Haloperidol Decanoate 100 mg/mL 70069-0868-01 Somerset 1 vial $15.598 AO Availability likely —
Haloperidol Decanoate 100 mg/mL 68001-0581-41 BluePoint 1 vial $16.016 AO Availability likely —
Haloperidol Decanoate 100 mg/mL 00143-9295-01 Hikma 1 vial $16.140 AO Availability likely —
Haloperidol Decanoate 100 mg/mL 63323-0471-01 Fresenius 1 vial $16.140 AO Availability likely —
Haloperidol decanoate 100 mg/mL 68001-0658-41 BluePoint 1 vial $16.140 AO Availability likely —
Haloperidol Decanoate 100 mg/mL 70069-0383-01 Somerset 1 vial $16.140 AO Availability likely —
Haloperidol decanoate 100 mg/mL 70710-1463-01 Zydus 1 vial $16.140 AO Availability likely —
Haloperidol Decanoate 100 mg/mL 72603-0230-01 NorthStar 1 vial $16.140 AO Availability likely —
Haloperidol Decanoate 100 mg/mL 10147-0922-05 Patriot 5 ampules $29.346 — FDA listed —
Haloperidol Decanoate 100 mg/mL 68001-0579-48 BluePoint 5 ampules $29.346 AO FDA listed —
Haloperidol Decanoate 100 mg/mL 70069-0031-05 Somerset 5 ampules $33.922 AO Availability likely —
Haldol Decanoate 100 mg/mL 50458-0254-14 Janssen 5 ampules — — Discontinued —
Haloperidol Decanoate 100 mg/mL 68083-0138-02 Gland 1 vial — AO FDA listed —
Haloperidol Decanoate 100 mg/mL 70518-4240-00 REMEDYREPACK 10 vials — AO FDA listed —
Haloperidol Decanoate 100 mg/mL 70518-4584-00 REMEDYREPACK 10 vials — AO FDA listed —
Haloperidol Decanoate 100 mg/mL 70756-0616-05 Lifestar 5 vials — AO FDA listed —
Haloperidol decanoate 100 mg/mLthis 70771-1853-01 Zydus 1 vial — AO FDA listed —
Haloperidol decanoate 100 mg/mL 70771-1854-01 Zydus 1 vial — AO 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

🏛️
2019
On the market since
Nov 2019
📍
2026
Currently FDA-listed
7 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.

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 applicationANDA211180 (ANDA)
Labeler code70771
First marketedNov 2019
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 144 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 50 mg/mL Carton (3 vials per carton) NDC 70771-1851-9 Haloperidol Decanoate Injection 50 mg/mL* For Intramuscular Use Only 3 X 1 mL Single-Dose Vials Sterile Rx only 250 mg/5 mL (50 mg/mL) Carton (1 vial per carton) NDC 70771-1852-1 Haloperidol Decanoate Injection 250 mg/5 mL* (50 mg/mL) For Intramuscular Use Only 5 mL Multiple-Dose Vial Sterile Rx only 100 mg/mL Carton (1 vial per carton) NDC 70771-1853-1 Haloperidol Decanoate Injection 100 mg/mL* For Intramuscular Use Only 1 mL Single-Dose Vial Sterile Rx only 500 mg/5 mL (100 mg/mL) Carton (1 vial per carton) NDC 70771-1854-1 Haloperidol Decanoate Injection 500 mg/5 mL* (100 mg/mL) For Intramuscular Use Only 5 mL Multiple-Dose Vial Sterile Rx only 50 mg per mL carton label 250 mg per 5 mL carton label 100 mg per mL carton label 500 mg per 5 mL carton label

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 Haloperidol Decanoate — 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 Haloperidol Decanoate. 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
$3.2M
Claims incl. refills
75.5K
Beneficiaries
26.5K
Spend / beneficiary
$120.83
Spend / claim
$42.32
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 ✓ 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 1 other package presentation of this same product, including 5 vials (70771-1853-05). 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.
← 70771-1852-01 · Zydus 70771-1854-01 · 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.