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 — NDC 70771-1854-5 (Billing 70771-1854-05)
by Zydus Lifesciences Limited · 5 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE
This is a package of Haloperidol decanoate 100 mg/mL Injection from Zydus Lifesciences Limited, marketed since Nov 2019 and currently FDA-listed.
NDC 70771-1854-05
🏷️ FDA NDC (as labeled)
70771-1854-5
billing pads the package segment with a zero
This package
Contains5 mL in 1 vial, multi-dose
Pack sizes2 compare ↓
Also priced by: Part D plans $19.84/unit — full pricing hub ↓
🗂️ 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 →
⚠️
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)
70771-1854-5
Product NDC
70771-1854
11-digit billing NDC
70771185405
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 70771-1854-5 — 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 → 70771-1854-05. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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.
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Haloperidol decanoate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 | $19.84 | $99.18 / 5 vials |
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 70771-1854-01 70771-1854-1 Main listing | 1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE | 2019-11-14 | — | Active |
| 70771-1854-05 You're viewing this | 5 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE | 2019-11-14 | — | Active |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 5 vial, multi-dose in 1 carton / 5 ml in 1 vial, multi-dose.
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Haloperidol Decanoate 100 mg/mL 72485-0521-10 | Armas | 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 25021-0833-01 | Sagent | 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 00143-9296-01 | Hikma | 1 vial | $15.598 | AO | Availability likely | — |
| haloperidol decanoate 500 mg/5mL 25021-0834-05 | Sagent | 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 500 mg/5mL 68001-0659-41 | BluePoint | 1 vial | $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 70069-0868-01 | Somerset | 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 500 mg/5mL 72485-0522-01 | Armas | 1 vial | $15.598 | 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 68001-0581-41 | BluePoint | 1 vial | $16.016 | AO | Availability likely | — |
| Haloperidol Decanoate 100 mg/mL 63323-0471-01 | Fresenius | 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 72603-0230-01 | NorthStar | 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 00143-9295-01 | Hikma | 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 500 mg/5mL 68001-0582-41 | BluePoint | 1 vial | $26.499 | AO | FDA listed | — |
| Haloperidol Decanoate 100 mg/mL 68001-0579-48 | BluePoint | 5 ampules | $29.346 | AO | FDA listed | — |
| Haloperidol Decanoate 100 mg/mL 10147-0922-05 | Patriot | 5 ampules | $29.346 | — | FDA listed | — |
| Haloperidol Decanoate 100 mg/mL 70069-0031-05 | Somerset | 5 ampules | $33.922 | AO | Availability likely | — |
| Haloperidol Decanoate 100 mg/mL 68083-0138-02 | Gland | 1 vial | — | AO | FDA listed | — |
| Haloperidol Decanoate 500 mg/5mL 70756-0625-05 | Lifestar | 5 vials | — | AO | FDA listed | — |
| Haloperidol decanoate 100 mg/mLthis 70771-1854-05 | Zydus | 5 vials | — | AO | FDA listed | — |
| Haloperidol decanoate 100 mg/mL 70771-1853-01 | Zydus | 1 vial | — | AO | FDA listed | — |
| Haldol Decanoate 100 mg/mL 50458-0254-14 | Janssen | 5 ampules | — | — | Discontinued | — |
| 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/mL 70518-4240-00 | REMEDYREPACK | 10 vials | — | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
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.
- FDA Orange Book · refreshed Sep 3, 2026
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 LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
-
UNII QX10HYY4QV
Sesame oil is a plant-derived oil from sesame seeds. It's used in medicines as a solvent or carrier to dissolve or suspend active ingredients, helping them mix evenly throughout the formulation.
2 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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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 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
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 ↗
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) | ✓ 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 1 vial (70771-1854-01). 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.
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.