Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Lurasidone hydrochloride 120 mg Tablet, Coated, 500-count — NDC 70771-1738-5 (Billing 70771-1738-05)
by Zydus Lifesciences Limited · 500 TABLET, COATED in 1 BOTTLE
This is a package of 500 tablets of Lurasidone hydrochloride 120 mg Tablet, Coated from Zydus Lifesciences Limited, marketed since Feb 2023 and currently FDA-listed.
NDC 70771-1738-05
🏷️ FDA NDC (as labeled)
70771-1738-5
billing pads the package segment with a zero
This package
Contains500-count
Pack sizes5 compare ↓
Also priced by: Part D plans $0.5403/unit — full pricing hub ↓
Product page 70771-1738-01
Also comes in:
10 tablets 70771-1738-4
30 tablets 70771-1738-3
90 tablets 70771-1738-9
100 tablets 70771-1738-1
🗂️ 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 →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
70771-1738-5
Product NDC
70771-1738
11-digit billing NDC
70771173805
UNII
O0P4I5851I
Application #
ANDA208052
SPL Set ID
0f5f8228-1304-4981-8577-029136627260
Established class (EPC)
Atypical Antipsychotic
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2023-02-01
Route
ORAL
Dosage form
TABLET, COATED
Substance
LURASIDONE HYDROCHLORIDE
TE code (Orange Book)
AB · RLD · RS
Quick answers
- RxCUI (RxNorm): 1040031
Why two NDCs?
The FDA registers this code as 70771-1738-5 — 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 → 70771-1738-05. 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 Atypical Antipsychotic class.
Pharmacologic class
Atypical Antipsychotic
Drug family (ATC)
Indole 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
Lurasidone is used to treat the symptoms of schizophrenia (a mental illness that affects how a person thinks, feels and behaves) and bipolar disorder (manic depressive disorder; a disease that causes depression, mania, and other abnormal moods). Lurasidone is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- Yes, food really does matter here. Taking lurasidone with a meal of at least 350 calories more than doubles the amount of medication your body actually absorbs — so if you take it...
- Why do I have to take lurasidone with food? Does it matter what I eat?
- The most common things people notice are sleepiness, nausea, and a restless feeling called akathisia — where you feel like you need to keep moving or can't sit still. These are usu...
- What side effects should I actually expect, and which ones do I need to call my doctor about?
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 Lurasidone hydrochloride?
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 | $0.5403 | $270.15 / 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 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 |
|---|---|---|---|---|
| 70771-1738-01 70771-1738-1 Main listing | 100 TABLET, COATED in 1 BOTTLE | 2023-02-01 | — | Active |
| 70771-1738-03 70771-1738-3 | 30 TABLET, COATED in 1 BOTTLE | 2023-02-01 | — | Active |
| 70771-1738-04 70771-1738-4 | 10 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK | 2023-02-01 | — | Active |
| 70771-1738-05 You're viewing this | 500 TABLET, COATED in 1 BOTTLE | 2023-02-01 | — | Active |
| 70771-1738-09 70771-1738-9 | 90 TABLET, COATED in 1 BOTTLE | 2023-02-01 | — | Active |
Pack size FAQ
What quantity is in this package?
This is a 500-count package — 500 tablet, coated in 1 bottle.
How does this package differ from NDC 70771-1738-03?
Both are Lurasidone hydrochloride 120 mg Tablet, Coated — the drug itself is identical. This page's package is the 500-count one, while NDC 70771-1738-03 is the 30 tablets package.
What NDC number is used to bill for this package of Lurasidone hydrochloride 120 mg Tablet, Coated?
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 |
|---|---|---|---|---|---|---|
| lurasidone hydrochloride 120 mg 00904-7359-04 | Major | 1 tablet | $0.487 | AB | Availability likely | — |
| lurasidone hydrochloride 120 mg 00904-7425-46 | MAJOR | 30 tablets | $0.487 | AB | Availability likely | — |
| lurasidone hydrochloride 120 mg 33342-0423-07 | Macleods | 30 tablets | $0.487 | AB | Availability likely | — |
| Lurasidone Hydrochloride 120 mg 43598-0355-30 | Dr. | 30 tablets | $0.487 | AB | Availability likely | — |
| Lurasidone Hydrochloride 120 mg 76282-0525-30 | Exelan | 30 tablets | $0.487 | AB | Availability likely | — |
| lurasidone hydrochloride 120 mg 16729-0350-10 | Accord | 30 tablets | $0.674 | AB | FDA listed | — |
| Lurasidone Hydrochloride 120 mg 65162-0882-03 | Amneal | 30 tablets | $0.674 | — | FDA listed | — |
| Lurasidone Hydrochloride 120 mg 13668-0467-05 | Torrent | 500 tablets | — | AB | FDA listed | — |
| Lurasidone Hydrochloride 120 mg 23155-0891-01 | Heritage | 100 tablets | — | AB | FDA listed | — |
| Lurasidone Hydrochloride 120 mg 31722-0084-05 | Camber | 500 tablets | — | AB | FDA listed | — |
| Lurasidone Hydrochloride 120 mg 46708-0498-10 | Alembic | 10 tablets | — | AB | FDA listed | — |
| Lurasidone Hydrochloride 120 mg 47335-0579-13 | Sun | 500 tablets | — | — | FDA listed | — |
| Lurasidone Hydrochloride 120 mg 51407-0838-05 | Golden | 500 tablets | — | AB | FDA listed | — |
| Lurasidone Hydrochloride 120 mg 53746-0882-30 | Amneal | 30 tablets | — | — | FDA listed | — |
| Lurasidone Hydrochloride 120 mg 62332-0498-10 | Alembic | 10 tablets | — | AB | FDA listed | — |
| Latuda 120 mg 63402-0312-04 | Sumitomo | 7 tablets | — | AB | FDA listed | — |
| Lurasidone Hydrochloride 120 mg 65862-0957-05 | Aurobindo | 500 tablets | — | AB | FDA listed | — |
| lurasidone hydrochloride 120 mg 67877-0642-05 | Ascend | 500 tablets | — | AB | FDA listed | — |
| lurasidone hydrochloride 120 mg 68180-0674-02 | Lupin | 500 tablets | — | AB | FDA listed | — |
| Lurasidone hydrochloride 120 mg 68382-0968-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Lurasidone Hydrochloride 120 mg 69097-0937-02 | Cipla | 30 tablets | — | AB | FDA listed | — |
| Lurasidone hydrochloride 120 mgthis 70771-1738-05 | Zydus | 500 tablets | — | AB | FDA listed | — |
| lurasidone hydrochloride 120 mg 72205-0211-05 | Novadoz | 500 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2023
On the market since
Feb 2023
📍
2026
Currently FDA-listed
3 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 Oct 3, 2026
What it looks like
Color
Yellow / White
ShapeOval
ImprintC35
Size15 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.
- FDA label on DailyMed · label index refreshed Oct 1, 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 OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
-
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
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 TUF2IVW3M2
Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
-
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.
12 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 applicationANDA208052 (ANDA)
Labeler code70771
First marketedFeb 2023
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.
💬 Medication Guide ▾
SPL MEDGUIDE
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1734-3 Lurasidone hydrochloride tablets, 20 mg 30 tablets Rx only NDC 70771-1735-9 Lurasidone hydrochloride tablets, 40 mg 90 tablets Rx only NDC 70771-1736-3 Lurasidone hydrochloride tablets, 60 mg 30 tablets Rx only NDC 70771-1737-3 Lurasidone hydrochloride tablets, 80 mg 30 tablets Rx only NDC 70771-1738-3 Lurasidone hydrochloride tablets, 120 mg 30 tablets Rx only 20 mg 40 mg 60 mg 80 mg 120 mg
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 ↗
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 4 other package presentations of this same product, including 10 tablets (70771-1738-04), 30 tablets (70771-1738-03), 90 tablets (70771-1738-09). 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.