Trazodone Hydrochloride 50 mg Tablet, 100-count
by REMEDYREPACK INC. · 100 POUCH in 1 BOX (70518-4760-0) / 1 TABLET in 1 POUCH (70518-4760-1)
NDC 70518-4760-00
🏷️ FDA NDC (as labeled)
70518-4760-0
billing pads the package segment with a zero
Rx only
Generic
On market
Non-controlled
🗂️ Data synced Sep 26, 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 Trazodone Hydrochloride (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 24, 2026 — Presence of Foreign Tablets/Capsules (Teva Pharmaceuticals USA, Inc) · FDA recall D-0834-2026
Class II · Jan 26, 2026 — Presence of Foreign Tablets/Capsules (Granules Pharmaceuticals Inc.) · FDA recall D-0305-2026
Class III · Dec 19, 2025 — Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0247-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
70518-4760-0
Product NDC
70518-4760
11-digit billing NDC
70518476000
Application #
ANDA218988
SPL Set ID
5b9f0b60-0c25-4303-88f1-44bcb347bc49
Established class (EPC)
Serotonin Reuptake Inhibitor
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-09-22
Route
ORAL
Dosage form
TABLET
Substance
TRAZODONE HYDROCHLORIDE
TE code (Orange Book)
AB · RLD · RS
Why two NDCs?
The FDA registers this code as 70518-4760-0 — 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 → 70518-4760-00. 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.
🏭 Manufacturer & labeler
LabelerREMEDYREPACK INC.
Application holderGRANULES INDIA LTD
FDA applicationANDA218988 (ANDA)
Labeler code70518
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio1,520 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
📗 Our plain-language guide HelloPharmacist
- Trazodone is FDA-approved to treat major depressive disorder — that's clinical depression — in adults. It comes as a tablet (Trazodone Hydrochloride or Trazodone Hcl) or as an oral...
- Always take it shortly after a meal or a light snack. Food helps your body absorb the drug more consistently, and it can also help reduce any stomach upset. Just try to keep that t...
- Should I take trazodone with food or on an empty stomach?
- Drowsiness is one of the most commonly reported side effects — your prescriber may actually suggest taking the larger dose at bedtime for that reason. Other common ones include diz...
Patient education
Supplement & herbal interactions
1
Nutrient depletion considerations
Trazodone may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 Trazodone Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
ShapeRound
ImprintL;2
Size7 mm
ScoringScored — splits in 2
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 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 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 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 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
-
UNII H8AV0SQX4D
A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
-
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.
6 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 · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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 |
|---|---|---|---|---|---|---|
| Trazodone Hydrochloride 50 mg 68382-0609-01 | Zydus | 100 tablets | $0.031 | AB | Availability likely | — |
| Trazodone Hydrochloride 50 mg 13107-0079-01 | Aurolife | 100 tablets | $0.031 | AB | Availability likely | — |
| Trazodone Hydrochloride 50 mg 13668-0330-01 | Torrent | 100 tablets | $0.031 | AB | Availability likely | — |
| Trazodone Hydrochloride 50 mg 68382-0805-01 | Zydus | 100 tablets | $0.031 | AB | Availability likely | — |
| Trazodone Hydrochloride 50 mg 00904-6868-61 | Major | 100 tablets | $0.031 | AB | Availability likely | — |
| Trazodone Hydrochloride 50 mg 70010-0231-01 | Granules | 100 tablets | $0.031 | AB | Availability likely | — |
| Trazodone Hydrochloride 50 mg 60687-0443-01 | American | 100 tablets | $0.031 | AB | Availability likely | — |
| Trazodone Hydrochloride 50 mg 50111-0560-01 | Teva | 100 tablets | $0.031 | AB | Availability likely | — |
| Trazodone Hydrochloride 50 mg 57664-0014-72 | Sun | 100 tablets | $0.031 | AB | Availability likely | — |
| Trazodone Hydrochloride 50 mg 64980-0672-01 | Rising | 100 tablets | $0.031 | AB | Availability likely | — |
| Trazodone Hydrochloride 50 mg 60687-0954-01 | American | 100 tablets | $0.031 | AB | Availability likely | — |
| Trazodone Hydrochloride 50 mg 16729-0299-01 | Accord | 100 tablets | $0.033 | AB | Availability likely | — |
| Trazodone Hydrochloride 50 mg 71205-0505-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 71205-0568-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 71610-0514-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 50090-5218-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 50090-6603-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 69584-0884-10 | Oxford | 100 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 80425-0326-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 80425-0502-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 76420-0672-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 00615-8371-05 | NCS | 15 tablets | — | AB | Discontinued | — |
| Trazodone Hydrochloride 50 mg 60505-2653-00 | Apotex | 100 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 70771-1128-00 | Zydus | 1000 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 50090-7943-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 70518-3290-01 | REMEDYREPACK | 30 tablets | — | AB | Discontinued | — |
| Trazodone Hydrochloride 50 mg 71335-0705-00 | Bryant | 14 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 70771-1938-00 | Zydus | 1000 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 45865-0167-30 | Medsource | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 51655-0366-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 67046-1506-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 68788-7118-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 71335-2651-00 | Bryant | 14 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 72789-0154-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 50090-7944-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 71205-0551-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 71610-0525-15 | Aphena | 15 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 42291-0868-10 | AvKARE | 1000 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 51407-0946-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 68071-2996-09 | NuCare | 90 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 68071-4410-02 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 70518-2929-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 70518-4363-00 | REMEDYREPACK | 60 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 71335-1575-00 | Bryant | 14 tablets | — | AB | Discontinued | — |
| Trazodone Hydrochloride 50 mg 55154-8087-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 70518-4441-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 71610-0529-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 71610-0874-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 67046-1684-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 87441-0081-01 | Unit | 30 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mg 72789-0591-90 | PD-Rx | 90 tablets | — | AB | FDA listed | — |
| Trazodone Hydrochloride 50 mgthis 70518-4760-00 | REMEDYREPACK | 100 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
🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.
🔬 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 Trazodone Hydrochloride — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 34%
Female · 66%
Unknown · 0%
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 |
|---|---|---|---|
| 70518-4760-00 You're viewing this | 100 POUCH in 1 BOX (70518-4760-0) / 1 TABLET in 1 POUCH (70518-4760-1) | 2026-09-22 | Active |
🧭 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 70518-4760-0, 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: 70518-4760-00, written without dashes as 70518476000. 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 70518-4760-00, the first segment (70518) is the labeler code FDA assigned to REMEDYREPACK INC.; the middle segment (4760) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 REMEDYREPACK INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
REMEDYREPACK INC. 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.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
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.