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Ramelteon 8 mg Tablet, 100-count — NDC 70771-1495-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ramelteon 8 mg Tablet, 100-count — NDC 70771-1495-1 (Billing 70771-1495-01)

by Zydus Lifesciences Limited · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Ramelteon 8 mg Tablet from Zydus Lifesciences Limited, marketed since Jul 2019 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 70771-1495-01
🏷️ FDA NDC (as labeled) 70771-1495-1 billing pads the package segment with a zero
This package
Contains100-count Pack sizes3 compare ↓
Also priced by: Part D plans $1.43/unit — full pricing hub ↓
Main listing for product 70771-1495 · Also comes in: 30 tablets 70771-1495-3 500 tablets 70771-1495-5
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

NDC database record

One package, one record: these facts belong to NDC 70771-1495-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70771 labeler · 1495 product · 1 package
Package marketed since
Jul 23, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7077114951 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70771-1495-1
Product NDC 70771-1495
11-digit billing NDC 70771149501
RxCUI 577348
UNII 901AS54I69
Application # ANDA211567
SPL Set ID 14ba7994-476a-4978-8cac-29989335a63c
Established class (EPC) Melatonin Receptor Agonist
Mechanism of action Melatonin Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-07-23
Route ORAL
Dosage form TABLET
Substance RAMELTEON
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 577348
Why two NDCs? The FDA registers this code as 70771-1495-1 — 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 → 70771-1495-01. 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 Melatonin Receptor Agonist class.

Pharmacologic class Melatonin Receptor Agonist
Drug family (ATC) Melatonin receptor agonists
How it works Melatonin Receptor Agonists
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

Ramelteon is used to help patients who have sleep-onset insomnia (difficulty falling asleep) fall asleep more quickly. Ramelteon is in a class of medications called melatonin receptor agonists. It works similarly to melatonin, a natural substance in the brain that is needed for sleep.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats insomnia when your main trouble is falling asleep. It works on melatonin receptors in the brain that help regulate your sleep-wake cycle.
  • Take one tablet by mouth within 30 minutes of going to bed. Don't take it with or right after a high-fat meal, since that changes how it's absorbed. Follow your prescriber's direct...
  • The more common ones are sleepiness, dizziness, tiredness, nausea and worsening insomnia. Avoid driving or other risky tasks after your dose. Do only what you need to get ready for...
  • Get emergency help for swelling of the tongue, throat or face, or trouble breathing. Call your doctor if you do things like drive or cook while asleep, see things that aren't there...
📖 Read our full Ramelteon 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.

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 $1.43 $143.01 / 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70771-1495-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2019-07-23 — Active
70771-1495-03 70771-1495-3 30 TABLET in 1 BOTTLE 2019-07-23 — Active
70771-1495-05 70771-1495-5 500 TABLET in 1 BOTTLE 2019-07-23 — Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle.
How does this package differ from NDC 70771-1495-03?
Both are Ramelteon 8 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 70771-1495-03 is the 30 tablets package.
What NDC number is used to bill for this package of Ramelteon 8 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
Ramelteon 8 mg 50268-0708-15 AvPAK 50 tablets $0.657 AB Discontinued —
Ramelteon 8 mg 00591-2191-01 Actavis 100 tablets $0.660 AB Availability likely —
Ramelteon 8 mg 00832-1250-11 Upsher-Smith 100 tablets $0.660 AB Availability likely —
Ramelteon 8 mg 00904-7494-06 Major 50 tablets $0.660 AB Availability likely —
Ramelteon 8 mg 42571-0375-01 Micro 100 tablets $0.660 AB Availability likely —
Ramelteon 8 mg 52817-0235-10 TruPharma, 100 tablets $0.660 AB Availability likely —
Ramelteon 8 mg 59651-0505-01 Aurobindo 100 tablets $0.660 AB Availability likely —
Ramelteon 8 mg 60687-0692-65 American 50 tablets $0.660 AB Availability likely —
Ramelteon 8 mg 70700-0272-05 Xiromed, 500 tablets $0.660 AB Availability likely —
Ramelteon 8 mg 70710-1344-01 Zydus 100 tablets $0.660 AB Availability likely —
Ramelteon 8 mg 85742-0023-22 Kanchan 30 tablets $0.660 AB Availability likely —
Ramelteon 8 mg 43598-0741-01 Dr.Reddys 100 tablets $0.667 AB Discontinued —
Rozerem 8 mg 64764-0805-10 Takeda 100 tablets $12.417 AB Availability likely —
Ramelteon 8 mg 42291-0776-30 AvKARE 30 tablets — — FDA listed —
Ramelteon 8 mg 50268-0822-15 AvPAK 50 tablets — AB FDA listed —
Ramelteon 8 mg 51407-0523-01 Golden 100 tablets — AB FDA listed —
Ramelteon 8 mg 63629-8531-01 Bryant 30 tablets — — FDA listed —
ramelteon 8 mg 70010-0028-01 Granules 100 tablets — — FDA listed —
Ramelteon 8 mg 70518-4257-00 REMEDYREPACK 30 tablets — AB FDA listed —
Ramelteon 8 mgthis 70771-1495-01 Zydus 100 tablets — AB FDA listed —
Ramelteon 8 mg 71205-0918-00 Proficient 100 tablets — — FDA listed —
Ramelteon 8 mg 71335-1853-01 Bryant 30 tablets — AB FDA listed —
Ramelteon 8 mg 71335-2186-01 Bryant 30 tablets — AB FDA listed —
Ramelteon 8 mg 71335-2310-01 Bryant 30 tablets — AB FDA listed —
Ramelteon 8 mg 71335-2411-01 Bryant 30 tablets — AB FDA listed —
Ramelteon 8 mg 71335-2886-01 Bryant 30 tablets — AB FDA listed —
Ramelteon 8 mg 72162-2161-03 Bryant 30 tablets — AB FDA listed —
Ramelteon 8 mg 72162-2169-03 Bryant 30 tablets — AB FDA listed —
Ramelteon 8 mg 72162-2176-03 Bryant 30 tablets — AB FDA listed —
Ramelteon 8 mg 72162-2644-01 Bryant 100 tablets — AB FDA listed —
Ramelteon 8 mg 72189-0153-30 DIRECT 30 tablets — AB FDA listed —
Ramelteon 8 mg 72189-0369-30 Direct_Rx 30 tablets — AB FDA listed —
Ramelteon 8 mg 72189-0484-30 Direct_Rx 30 tablets — AB FDA listed —
Ramelteon 8 mg 72319-0005-01 i3 30 tablets — AB FDA listed —
Ramelteon 8 mg 76420-0628-01 Asclemed 100 tablets — AB FDA listed —
Ramelteon 8 mg 76420-0880-01 Asclemed 100 tablets — AB FDA listed —
Ramelteon 8 mg 80425-0203-01 Advanced 30 tablets — AB FDA listed —
Ramelteon 8 mg 80425-0343-01 Advanced 30 tablets — AB FDA listed —
Ramelteon 8 mg 82804-0216-30 Proficient 30 tablets — AB FDA listed —
Ramelteon 8 mg 87063-0189-01 ASCLEMED 100 tablets — AB FDA listed —
Ramelteon 8 mg 85766-0251-01 Sportpharm 100 tablets — AB FDA listed —
Ramelteon 8 mg 10135-0838-01 Marlex 100 tablets — AB FDA listed —
Ramelteon 8 mg 80425-0593-01 Advanced 30 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

🏛️
2019
On the market since
Jul 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.

What it looks like

Color Yellow
ShapeRound
Imprint1344
Size7 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.

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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 0VUT3PMY82
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
  • UNII 30IQX730WE
    Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • 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 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.

11 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.

Manufacturer & labeler

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA211567 (ANDA)
Labeler code70771
First marketedJul 2019
Product typeHuman Prescription Drug
Portfolio720 products on file

More NDCs from Zydus Lifesciences Limited labeler code 70771

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.
💬 Medication Guide 📄 Package Label / Principal Display Panel
💬 Medication Guide 2 words ▾

SPL MEDGUIDE

📄 Package Label / Principal Display Panel 16 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1495-3 Ramelteon Tablets, 8 mg 30 Tablets Rx only Ramelteon Tablets

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 Ramelteon — the program that covers self-administered drugs. 12 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 Ramelteon. 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
$6.62M
Claims incl. refills
94.1K
Beneficiaries
51.8K
Spend / beneficiary
$127.88
Spend / claim
$70.38
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 2 other package presentations of this same product, including 30 tablets (70771-1495-03), 500 tablets (70771-1495-05). 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.
← 70771-1494-00 · Zydus 70771-1498-06 · 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.