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Tramadol Hydrochloride 50 mg Tablet, Coated, 30-count — NDC 87441-0089-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tramadol Hydrochloride 50 mg Tablet, Coated, 30-count — NDC 87441-089-01 (Billing 87441-0089-01)

by Unit Dose Solutions, Inc. · 30 TABLET, COATED in 1 BLISTER PACK

This is a package of 30 tablets of Tramadol Hydrochloride 50 mg Tablet, Coated from Unit Dose Solutions, Inc., marketed since Sep 2026 and currently FDA-listed. It is this product's only package size.

NDC 87441-0089-01
🏷️ FDA NDC (as labeled) 87441-089-01 billing pads the product segment with a zero
Rx only Generic On market CIV ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 2, 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

⚠️
Other active recalls for Tramadol Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 26, 2024 — Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol (Rubicon Research Private Limited) · FDA recall D-0487-2024
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) 87441-089-01
Product NDC 87441-089
11-digit billing NDC 87441008901
Application # ANDA076003
SPL Set ID 5c2ac7cb-3a38-2174-e063-6394a90a95cc
Established class (EPC) Opioid Agonist
Mechanism of action Full Opioid Agonists
DEA schedule CIV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-09-23
Route ORAL
Dosage form TABLET, COATED
Substance TRAMADOL HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 87441-089-01 — a 5-3-2 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 product segment → 87441-0089-01. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It treats pain that is severe enough to need an opioid when other options haven’t worked or can’t be tolerated. Extended-release forms are for ongoing, around-the-clock pain, not a...
  • Take it by mouth exactly as prescribed. If you have extended-release tablets, swallow them whole, never crush, chew or cut them. Don’t take it with other tramadol products.
  • Dizziness, nausea, constipation, headache, sleepiness, itching and dry mouth are common. Call your doctor for seizures, severe dizziness, or agitation, fever and shaking. Slow brea...
  • Avoid alcohol. Mixing tramadol with alcohol, sleep aids, benzodiazepines or other opioids can cause dangerous sedation and slowed breathing. Tell me about any antidepressants, MAOI...
📖 Read our full Tramadol guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 · 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
87441-0089-01 You're viewing this Main listing 30 TABLET, COATED in 1 BLISTER PACK 2026-09-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tramadol Hydrochloride 50 mg 16571-0716-01 Rising 100 tablets $0.025 AB Availability likely —
tramadol hydrochloride 50 mg 64380-0791-01 Strides 100 tablets $0.025 AB Availability likely —
Tramadol Hydrochloride 50 mg 60687-0795-01 American 1 tablet $0.025 AB Availability likely —
Tramadol Hydrochloride 50 mg 60219-2348-01 Amneal 100 tablets $0.025 AB Availability likely —
Tramadol Hydrochloride 50 mg 64980-0614-01 Rising 100 tablets $0.025 AB Availability likely —
Tramadol Hydrochloride 50 mg 00904-7496-61 Major 1 tablet $0.025 AB Availability likely —
Tramadol Hydrochloride 50 mg 00093-3301-01 Teva 100 tablets $0.025 AB Availability likely —
Tramadol Hydrochloride 50 mg 29300-0355-01 Unichem 100 tablets $0.025 AB Availability likely —
Tramadol Hydrochloride 50 mg 72888-0080-00 Advagen 1000 tablets $0.025 AB Availability likely —
Tramadol Hydrochloride 50 mg 52817-0195-00 TRUPHARMA 1000 tablets $0.033 AB FDA listed —
Tramadol Hydrochloride 50 mg 63187-0063-15 Proficient 15 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 71610-0006-15 Aphena 15 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 76420-0733-00 Asclemed 1000 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 82868-0052-30 Northwind 30 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 50090-5789-00 A-S 30 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 68071-3644-03 NuCare 30 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 82804-0114-15 Proficient 15 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 55700-0997-01 Quality 120 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 70518-3824-00 REMEDYREPACK 30 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 71205-0740-15 Proficient 15 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 60760-0588-30 ST. 30 tablets — AB Discontinued —
Tramadol Hydrochloride 50 mg 60760-0772-09 ST. 9 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 68788-4035-01 Preferred 100 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 68788-8717-01 Preferred 100 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 70518-4248-00 REMEDYREPACK 30 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 71335-2518-00 Bryant 50 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 72189-0311-12 DirectRx 12 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 87063-0117-01 Asclemed 100 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 27808-0301-01 Cranbury 100 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 51407-0007-01 Golden 100 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 67296-1834-01 RedPharm 10 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 71335-2612-01 Bryant 8 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 68788-4114-01 Preferred 90 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 71610-0865-15 Aphena 15 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 80425-0274-01 Advanced 15 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 59651-0441-01 Aurobindo 100 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 60760-0727-09 St. 9 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 65162-0627-01 Amneal 10 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 68071-4119-01 NuCare 120 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 69238-2348-01 Amneal 100 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 80425-0548-01 Advanced 15 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 58118-2348-08 Clinical 30 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 68788-8121-01 Preferred 100 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 71335-9658-00 Bryant 50 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 80425-0276-01 Advanced 15 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 82804-0142-15 Proficient 15 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 50090-5790-01 A-S 90 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 68788-4040-01 Preferred 100 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 71335-2721-01 Bryant 8 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 80425-0501-01 Advanced 15 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 68071-3655-02 NuCare 12 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 71335-3147-00 Bryant 50 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 67046-1209-03 Coupler 30 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 80425-0588-01 Advanced 15 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 82868-0110-30 Northwind 30 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 70518-4713-00 REMEDYREPACK 30 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mgthis 87441-0089-01 Unit 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

🏛️
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.

What it looks like

Color white
ShapeRound
ImprintAN;627
Size9 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 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 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • 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.

9 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

LabelerUnit Dose Solutions, Inc.
Application holderAMNEAL PHARMACEUTICALS OF NEW YORK LLC
FDA applicationANDA076003 (ANDA)
Labeler code87441
First marketedSep 2026
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio87 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.

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
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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 Unit Dose Solutions, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Unit Dose Solutions, 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.
← 87441-0088-01 · Unit 87441-0090-01 · Unit →
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.