Ramelteon 8 mg Tablet, 30-count
by Zydus Lifesciences Limited · 30 TABLET in 1 BOTTLE (70771-1495-3)
NDC 70771-1495-03
🏷️ FDA NDC (as labeled)
70771-1495-3
billing pads the package segment with a zero
This package
Contains30-count
Pack sizes3 compare ↓
Also priced by: Part D plans $1.43/unit — full pricing hub ↓
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 →
🆔 Identity & classification
FDA NDC (as labeled)
70771-1495-3
Product NDC
70771-1495
11-digit billing NDC
70771149503
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
Why two NDCs?
The FDA registers this code as 70771-1495-3 — 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 → 70771-1495-03. 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.
🏭 Manufacturer & labeler
LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA211567 (ANDA)
Labeler code70771
First marketedJul 2019
Product typeHuman Prescription Drug
Portfolio716 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
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
- Ramelteon works differently from most other prescription sleep medications. Instead of sedating your brain with a broad chemical 'off switch,' it works the way your body's own mela...
- What exactly does ramelteon do, and is it like other sleep pills?
- Take ramelteon within 30 minutes of going to bed — not hours before. After you take it, stick to activities that prepare you for sleep and get into bed. Avoid eating a high-fat mea...
- When should I take it, and does it matter if I eat first?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ramelteon — tap one for details:
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.
💬 Questions about Ramelteon?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 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.
💲 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 | $1.43 | $42.90 / 30 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ramelteon 8 mg 00591-2191-01 | Actavis | 100 tablets | $0.657 | AB | Availability likely | — |
| Ramelteon 8 mg 00832-1250-11 | Upsher-Smith | 100 tablets | $0.657 | AB | Availability likely | — |
| Ramelteon 8 mg 00904-7494-06 | Major | 50 tablets | $0.657 | AB | Availability likely | — |
| Ramelteon 8 mg 42571-0375-01 | Micro | 100 tablets | $0.657 | AB | Availability likely | — |
| Ramelteon 8 mg 50268-0708-15 | AvPAK | 50 tablets | $0.657 | AB | Discontinued | — |
| Ramelteon 8 mg 52817-0235-10 | TruPharma, | 100 tablets | $0.657 | AB | Availability likely | — |
| Ramelteon 8 mg 59651-0505-01 | Aurobindo | 100 tablets | $0.657 | AB | Availability likely | — |
| Ramelteon 8 mg 60687-0692-65 | American | 50 tablets | $0.657 | AB | Availability likely | — |
| Ramelteon 8 mg 70700-0272-05 | Xiromed, | 500 tablets | $0.657 | AB | Availability likely | — |
| Ramelteon 8 mg 70710-1344-01 | Zydus | 100 tablets | $0.657 | 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 | $12.432 | 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 70771-1495-03 | Zydus | 30 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 85742-0023-22 | Kanchan | 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.
📊 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.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for RAMELTEON — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 41%
Female · 58%
Unknown · 1%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70771-1495-01 | 100 TABLET in 1 BOTTLE (70771-1495-1) | 2019-07-23 | Active |
| 70771-1495-03 You're viewing this | 30 TABLET in 1 BOTTLE (70771-1495-3) | 2019-07-23 | Active |
| 70771-1495-05 | 500 TABLET in 1 BOTTLE (70771-1495-5) | 2019-07-23 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 70771-1495-03?
NDC 70771-1495-03 is a 30-count package — 30 tablet in 1 bottle.
What is the difference between NDC 70771-1495-03 and NDC 70771-1495-01?
Both are Ramelteon 8 mg Tablet — the drug itself is identical. NDC 70771-1495-03 is the 30-count package, while NDC 70771-1495-01 is the 100 tablets package.
What NDC number is used to bill for this package of Ramelteon 8 mg Tablet?
Bill NDC 70771-1495-03 — the 11-digit billing format is 70771149503. 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 70771-1495-3, 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: 70771-1495-03, written without dashes as 70771149503. 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 70771-1495-03, the first segment (70771) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (1495) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 2 other package presentations of this same product, including 100 tablets (70771-1495-01), 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.
📄 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
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 ↗
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.