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Clonidine Hydrochloride .2 mg Tablet, 1,000-count — NDC 58657-0648-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clonidine Hydrochloride .2 mg Tablet, 1,000-count — NDC 58657-648-10 (Billing 58657-0648-10)

by Method Pharmaceuticals, LLC · 1000 TABLET in 1 BOTTLE

This is a package of 1,000 tablets of Clonidine Hydrochloride .2 mg Tablet from Method Pharmaceuticals, LLC, marketed since Jul 2020 and currently FDA-listed; retail pharmacies pay about $0.0330 per tablet (NADAC). It is the main listing for this product, which comes in 3 package sizes.

NDC 58657-0648-10
🏷️ FDA NDC (as labeled) 58657-648-10 billing pads the product segment with a zero
This package
Contains1,000-count Cost per ea$0.0330 NADAC Per package$33.00 / 1000 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.1684/unit · Part D plans $0.0688/unit — full pricing hub ↓
Main listing for product 58657-648 · Also comes in: 100 tablets 58657-648-01 500 tablets 58657-648-50
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58657-648-10
Product NDC 58657-648
11-digit billing NDC 58657064810
NCPDP billing unit EA — each (per item)
RxCUI 884173, 884185, 884189
UNII W76I6XXF06
Application # ANDA202297
SPL Set ID dffb5fdd-06c0-4275-9f89-9e12b3adf8a9
Established class (EPC) Central alpha-2 Adrenergic Agonist
Mechanism of action Adrenergic alpha2-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-07-01
Route ORAL
Dosage form TABLET
Substance CLONIDINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 36201010100310
GPI class cloNIDine HCl
GCN Seq No 000347
GCN 01391
HICL code 000113
Ingredient (HICL) Clonidine Hcl
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A4
Therapeutic class — intermediate (HIC2) Antihypertensives
HIC3 code A4B
Therapeutic class — specific (HIC3) Antihypertensives, Sympatholytic
AHFS code 24:24.00.00
AHFS class Central Alpha-Agonists
FDB label name CLONIDINE HCL 0.2 MG TABLET
FDB brand name Clonidine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 000347
  • GCN: 01391
  • GPI-14 (Medi-Span): 36201010100310
  • HICL (First Databank): 000113
  • AHFS class code: 24:24.00.00
  • RxCUI (RxNorm): 884173
Why two NDCs? The FDA registers this code as 58657-648-10 — 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 → 58657-0648-10. 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 Central alpha-2 Adrenergic Agonist class.

Pharmacologic class Central alpha-2 Adrenergic Agonist
Drug family (ATC) Imidazoline receptor agonists, Other antimigraine preparations, Sympathomimetics in glaucoma therapy
How it works Adrenergic alpha2-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

Label name CLONIDINE HCL 0.2 MG TABLET Ingredient Clonidine Hcl
📖 What it is MedlinePlus · NLM

Clonidine is used alone or in combination with other medications to treat high blood pressure. Clonidine is also used alone or in combination with other medications as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in children 6 years of age and older. Clonidine is in a class of medications called centrally acting alpha-agonist hypotensive agents. Clonidine treats high blood pressure by decreasing your heart rate and relaxing th...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Tablets, oral solutions, Nexiclon XR and patches lower high blood pressure. Certain extended-release products treat ADHD. The epidural injection is used...
  • No. Stopping suddenly can cause rebound high blood pressure, with headache, a racing heart, nervousness and anxiety. Your doctor will lower the dose gradually.
  • Sleepiness is common. Don't drive or use heavy equipment until you know how it affects you. Avoid alcohol, and ask me before combining it with other sedating medicines.
  • No. Extended-release clonidine tablets should be swallowed whole, not crushed, chewed or broken. They can be taken with or without food.
📖 Read our full Clonidine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Clonidine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Clonidine nutrient depletion report →
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.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.033 $33.00 / 1000 tablets
Medicaid paysCMS SDUD · 12 mo $0.1684 $168.40 / 1000 tablets
Medicare drug plans payPart D · Q2 2026 $0.0688 $68.80 / 1000 tablets
NADAC price history (per ea) — tap or hover for the price & month
Sep 2022 Feb 2024 Apr 2026 Sep 2026 $0.039 $0.032
▼ Down 8% over the last 16 months.
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 Per unit Per pack Marketing startMarketing endStatus
58657-0648-01 58657-648-01 100 TABLET in 1 BOTTLE $0.0330 / ea $3.30 2020-07-01 — Active
58657-0648-10 You're viewing this Main listing 1000 TABLET in 1 BOTTLE $0.0330 / ea $32.99 2020-07-01 — Active
58657-0648-50 58657-648-50 500 TABLET in 1 BOTTLE $0.0330 / ea $16.50 2020-07-01 — Active

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

This pack effectively ties for the lowest per-ea cost of the 3 priced pack sizes ($0.0330 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 93% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 1,000-count package — 1000 tablet in 1 bottle.
How does this package differ from NDC 58657-0648-01?
Both are Clonidine Hydrochloride .2 mg Tablet — the drug itself is identical. This page's package is the 1,000-count one, while NDC 58657-0648-01 is the 100 tablets package.
What NDC number is used to bill for this package of Clonidine Hydrochloride .2 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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clonidine Hydrochloride .2 mg 00228-2128-10 Actavis 100 tablets $0.033 AB Availability likely —
Clonidine Hydrochloride .2 mg 00904-7443-61 Major 100 tablets $0.033 AB Availability likely —
clonidine hydrochloride .2 mg 29300-0136-01 Unichem 100 tablets $0.033 AB Availability likely —
Clonidine Hydrochloride .2 mg 43547-0566-10 Solco 100 tablets $0.033 AB Availability likely —
clonidine hydrochloride .2 mg 50268-0193-15 AvPAK 50 tablets $0.033 AB Availability likely —
Clonidine hydrochloride .2 mg 52817-0181-00 TruPharma, 1000 tablets $0.033 — Availability likely —
Clonidine Hydrochloride .2 mgthis 58657-0648-10 Method 1000 tablets $0.033 AB Availability likely —
Clonidine Hydrochloride .2 mg 59651-0233-01 Aurobindo 100 tablets $0.033 AB Availability likely —
Clonidine Hydrochloride .2 mg 60687-0124-01 American 100 tablets $0.033 AB Availability likely —
Clonidine Hydrochloride .2 mg 68001-0238-00 BluePoint 100 tablets $0.033 AB Availability likely —
Clonidine Hydrochloride .2 mg 00615-8272-30 NCS 30 tablets — AB Discontinued —
clonidine hydrochloride .2 mg 43063-0925-30 PD-Rx 30 tablets — AB FDA listed —
clonidine hydrochloride .2 mg 46708-0307-10 Alembic 100 tablets — AB FDA listed —
clonidine hydrochloride .2 mg 50090-1909-00 A-S 30 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 51655-0362-26 Northwind 90 tablets — AB FDA listed —
Clonidine hydrochloride .2 mg 51655-0962-52 Northwind 30 tablets — — FDA listed —
Clonidine Hydrochloride .2 mg 55154-2577-00 Cardinal 10 tablets — AB FDA listed —
clonidine hydrochloride .2 mg 62332-0055-10 Alembic 100 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 63629-2316-01 Bryant 500 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 63629-2317-01 Bryant 100 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 63629-9269-01 Bryant 1000 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 67046-1000-03 Coupler 30 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 67046-1552-03 Coupler 30 tablets — AB FDA listed —
clonidine hydrochloride .2 mg 68071-3016-06 NuCare 60 tablets — AB FDA listed —
clonidine hydrochloride .2 mg 68788-8080-03 Preferred 30 tablets — AB FDA listed —
clonidine hydrochloride .2 mg 70518-1060-01 REMEDYREPACK 50 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 70518-3295-00 REMEDYREPACK 30 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 70518-4357-00 REMEDYREPACK 30 tablets — AB FDA listed —
clonidine hydrochloride .2 mg 71205-0218-20 Proficient 20 tablets — AB FDA listed —
Clonidine hydrochloride .2 mg 71205-0829-30 Proficient 30 tablets — — FDA listed —
clonidine hydrochloride .2 mg 71335-1495-01 Bryant 30 tablets — AB Discontinued —
Clonidine Hydrochloride .2 mg 71335-2692-01 Bryant 30 tablets — AB FDA listed —
Clonidine hydrochloride .2 mg 71335-3028-01 Bryant 30 tablets — — FDA listed —
Clonidine Hydrochloride .2 mg 72162-1680-01 Bryant 100 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 72162-2610-05 Bryant 500 tablets — AB FDA listed —
Clonidine hydrochloride .2 mg 76420-0285-01 Asclemed 100 tablets — — FDA listed —
clonidine hydrochloride .2 mg 87063-0182-01 ASCLEMED 100 tablets — AB FDA listed —
Clonidine Hydrochloride .2 mg 87441-0024-01 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

🏛️
2020
On the market since
Jul 2020
📍
2026
Currently FDA-listed
6 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 pink / orange
ShapeRound
ImprintYS;03
Size8 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 L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • 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 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 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 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.

8 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

LabelerMethod Pharmaceuticals, LLC
Application holderYUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
FDA applicationANDA202297 (ANDA)
Labeler code58657
First marketedJul 2020
Product typeHuman Prescription Drug
Portfolio78 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

INDICATIONS AND USAGE Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.

⏱️ Dosage and Administration 175 words ▾

DOSAGE AND ADMINISTRATION Adults The dose of clonidine hydrochloride tablets must be adjusted according to the patient's individual blood pressure response. The following is a general guide to its administration. Initial Dose 0.1 mg tablet twice daily (morning and bedtime).

Elderly patients may benefit from a lower initial dose. Maintenance Dose Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness.

The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed. Renal Impairment Patients with renal impairment may benefit from a lower initial dose.

Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.

⛔ Contraindications 19 words ▾

CONTRAINDICATIONS Clonidine hydrochloride tablets should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS ) .

⚠️ Warnings 196 words ▾

WARNINGS Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations.

Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine.

If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100. The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride tablets, but in many cases patients were receiving concomitant medication and a causal relationship has not been established.

Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome. Also reported were a weakly positive Coombs' test and increased sensitivity to alcohol. Cardiovascular : Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e. , sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud's phenomenon, syncope, and tachycardia.

Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis. Central Nervous System: Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares. Dermatological : Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria.

Gastrointestinal: Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudo-obstruction), salivary gland pain, and vomiting. Genitourinary: Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention. Hematologic : Thrombocytopenia.

Metaboli c : Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain. Musculoskeletal: Leg cramps and muscle or joint pain. Oro-otolaryngeal: Dryness of the nasal mucosa.

Ophthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of eyes.

🔄 Drug Interactions 180 words ▾

Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated.

Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e . g ., digitalis, calcium channel blockers, and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (See Toxicology ) .

Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT-prolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for clonidine oral tablets have not been established.

🤰 Pregnancy 209 words ▾

Pregnancy Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride tablets produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as 1/3 the oral MRDHD (1/15 the MRDHD on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating.

Increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6 to 15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg). No adequate, well-controlled studies have been conducted in pregnant women.

Clonidine crosses the placental barrier (see CLINICAL PHARMACOLOGY, , Pharmacokinetics ). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 22 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (See WARNINGS , Withdrawal ).

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Clonidine stimulates alpha-adrenoreceptors in the brain stem. This action results in reduced sympathetic outflow from the central nervous system and in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure. Clonidine hydrochloride tablets act relatively rapidly.

The patient's blood pressure declines within 30 to 60 minutes after an oral dose, the maximum decrease occurring within 2 to 4 hours. Renal blood flow and glomerular filtration rate remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and infrequent.

Acute studies with clonidine hydrochloride in humans have demonstrated a moderate reduction (15% to 20%) of cardiac output in the supine position with no change in the peripheral resistance: at a 45' tilt there is a smaller reduction in cardiac output and a decrease of peripheral resistance. During long term therapy, cardiac output tends to return to control values, while peripheral resistance remains decreased. Slowing of the pulse rate has been observed in most patients given clonidine, but the drug does not alter normal hemodynamic response to exercise.

Tolerance to the antihypertensive effect may develop in some patients, necessitating a reevaluation of therapy. Other studies in patients have provided evidence of a reduction in plasma renin activity and in the excretion of aldosterone and catecholamines. The exact relationship of these pharmacologic actions to the antihypertensive effect of clonidine has not been fully elucidated.

Clonidine acutely stimulates growth hormone release in both children and adults, but does not produce a chronic elevation of growth hormone with long-term use. Pharmacokinetics The pharmacokinetics of clonidine is dose-proportional in the range of 100 to 600 mcg. The absolute bioavailability of clonidine on oral administration is 70% to 80%.

Peak plasma clonidine levels are attained in approximately 1 to 3 hours. Following intravenous administration, clonidine displays biphasic disposition with a distribution half-life of about 20 minutes and an elimination half-life ranging from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function.

Clonidine crosses the placental barrier. It has been shown to cross the blood-brain barrier in rats. Following oral administration about 40% to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours.

About 50% of the absorbed dose is metabolized in the liver. Neither food nor the race of the patient influences the pharmacokinetics of clonidine. The antihypertensive effect is reached at plasma concentrations between about 0.2 and 2.0 ng/mL in patients with normal excretory function.

A further rise in the plasma levels will not enhance the antihypertensive effect.

📦 How Supplied / Storage and Handling 150 words ▾

HOW SUPPLIED Clonidine Hydrochloride Tablets, USP are supplied as follows: 0.1 mg: A pink tablet, in the shape of “ NDC 58657-647-01 (Bottle of 100) NDC 58657-647-50 (Bottle of 500) NDC 58657-647-10 (Bottle of 1000) 0.2 mg: An orange tablet, in the shape of " ”. NDC 58657-648-01 (Bottle of 100) NDC 58657-648-50 (Bottle of 500) NDC 58657-648-10 (Bottle of 1000) 0.3 mg: A light orange tablet, in the shape of " NDC 58657-649-01 (Bottle of 100) NDC 58657-649-50 (Bottle of 500) NDC 58657-649-10 (Bottle of 1000) Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [See USP Controlled Room Temperature].

Dispense in tight, light-resistant container. Manufactured by: Yung Shin Pharmaceutical Ind. Co., Ltd.

Tachia, Taichung 43769 TAIWAN Distributed by: Method Pharmaceuticals, LLC 7333 Jack Newell Blvd. North, Suite 300 Fort Worth, Texas 76118 To report ADVERSE DRUG EXPERIENCE, please call Method Pharmaceuticals at 1-877-250-3427 Revised: 06/20 1 2 3

📋 Description 129 words ▾

DESCRIPTION Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, calcium phosphate dibasic, hydroxypropyl cellulose, microcrystalline cellulose, lactose monohydrate and magnesium stearate.

In addition, the 0.1 mg tablets contain FD&C Red No. 40, and the 0.2 mg and 0.3 mg tablets contain FD&C Yellow No. 6 as color additives respectively.

Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol. desc

💬 Information for Patients 89 words ▾

Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets therapy without their physician's advice. Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs.

Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets may cause dryness of eyes.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General In patients who have developed localized contact sensitization to transdermal clonidine, continuation of transdermal clonidine or substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction to transdermal clonidine, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema.) The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs.

There are post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring IV atropine, IV isoproterenol and temporary cardiac pacing while taking clonidine. In hypertension caused by pheochromocytoma, no therapeutic effect of clonidine hydrochloride tablets can be expected. Perioperative Use Administration of clonidine hydrochloride tablets should be continued to within four hours of surgery and resumed as soon as possible thereafter.

Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required. Information for Patients Patients should be cautioned against interruption of clonidine hydrochloride tablets therapy without their physician's advice. Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery.

Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride tablets may cause dryness of eyes. Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs.

If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e . g ., digitalis, calcium channel blockers, and beta-blockers.

Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (See Toxicology ) . Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT-prolongation, ventricular fibrillation) of high intravenous doses of haloperidol.

Causal relationship and relevance for clonidine oral tablets have not been established. Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid.

In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, acco… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 24 words ▾

Nursing Mothers As clonidine hydrochloride is excreted in human milk, caution should be exercised when clonidine hydrochloride tablets are administered to a nursing woman.

🧬 Pharmacokinetics 174 words ▾

Pharmacokinetics The pharmacokinetics of clonidine is dose-proportional in the range of 100 to 600 mcg. The absolute bioavailability of clonidine on oral administration is 70% to 80%. Peak plasma clonidine levels are attained in approximately 1 to 3 hours.

Following intravenous administration, clonidine displays biphasic disposition with a distribution half-life of about 20 minutes and an elimination half-life ranging from 12 to 16 hours. The half-life increases up to 41 hours in patients with severe impairment of renal function. Clonidine crosses the placental barrier.

It has been shown to cross the blood-brain barrier in rats. Following oral administration about 40% to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver.

Neither food nor the race of the patient influences the pharmacokinetics of clonidine. The antihypertensive effect is reached at plasma concentrations between about 0.2 and 2.0 ng/mL in patients with normal excretory function. A further rise in the plasma levels will not enhance the antihypertensive effect.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 128 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m 2 basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD).

In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m' basis.)

📄 Package Label / Principal Display Panel 48 words ▾

PRINCIPAL DISPLAY PANEL NDC 58657-647-10 CLONIDINE HYDROCHLORIDE TABLETS, USP 0.1 mg Rx Only 1000 Tablets 1

PRINCIPAL DISPLAY PANEL NDC 58657-648-10 CLONIDINE HYDROCHLORIDE TABLETS, USP 0.2 mg Rx Only 1000 Tablets 2

PRINCIPAL DISPLAY PANEL NDC 58657-649-10 CLONIDINE HYDROCHLORIDE TABLETS, USP 0.3 mg Rx Only 1000 Tablets 3

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
41.1K
Units reimbursed last 4 qtrs
1.8M
Gross reimbursed last 4 qtrs
$307.2K
Avg / prescription
$7.48
Avg / unit
$0.1684
Latest quarter Q1 2026
11.5KRx
Medicaid pays / ea
$0.1684
gross reimbursed
vs
NADAC / ea
$0.0330
acquisition cost
=
Spread
+$0.1354
+410% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
21% FFS 79% MCO
Fee-for-service · 8,744 Rx Managed care · 32,348 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 4,458 units · 57.1 per 100k residents WA Idaho: 4,810 units · 245 per 100k residents ID Montana: 2,112 units · 187 per 100k residents MT North Dakota: 2,849 units · 364 per 100k residents ND Minnesota: 55,529 units · 968 per 100k residents MN Wisconsin: 24,935 units · 422 per 100k residents WI Michigan: 50,645 units · 505 per 100k residents MI New York: 129,162 units · 660 per 100k residents NY Vermont: 12,545 units · 1,939 per 100k residents VT New Hampshire: no data reported NH Oregon: 2,976 units · 70.3 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 12,125 units · 1,319 per 100k residents SD Iowa: 119,650 units · 3,731 per 100k residents IA Illinois: 54,875 units · 437 per 100k residents IL Indiana: 36,486 units · 532 per 100k residents IN Ohio: 43,811 units · 372 per 100k residents OH Pennsylvania: 65,108 units · 502 per 100k residents PA New Jersey: 28,913 units · 311 per 100k residents NJ Massachusetts: 24,816 units · 354 per 100k residents MA California: 4,517 units · 11.6 per 100k residents CA Utah: 3,250 units · 95.1 per 100k residents UT Colorado: 3,733 units · 63.5 per 100k residents CO Nebraska: 42,550 units · 2,151 per 100k residents NE Missouri: 24,854 units · 401 per 100k residents MO Kentucky: 33,789 units · 747 per 100k residents KY West Virginia: 20,571 units · 1,162 per 100k residents WV Virginia: 16,048 units · 184 per 100k residents VA Maryland: 44,162 units · 715 per 100k residents MD Connecticut: 24,412 units · 675 per 100k residents CT Rhode Island: no data reported RI Arizona: 8,423 units · 113 per 100k residents AZ New Mexico: 2,371 units · 112 per 100k residents NM Kansas: 7,027 units · 239 per 100k residents KS Arkansas: 9,364 units · 305 per 100k residents AR Tennessee: 10,694 units · 150 per 100k residents TN North Carolina: 55,857 units · 516 per 100k residents NC South Carolina: 6,375 units · 119 per 100k residents SC Delaware: 1,500 units · 145 per 100k residents DE Oklahoma: 78,403 units · 1,934 per 100k residents OK Louisiana: 100,401 units · 2,195 per 100k residents LA Mississippi: 19,078 units · 649 per 100k residents MS Alabama: 16,475 units · 323 per 100k residents AL Georgia: 12,136 units · 110 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 533,385 units · 1,749 per 100k residents TX Florida: 68,912 units · 305 per 100k residents FL
Units reimbursed · per 100k residents
11.63,731
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Iowa 3,731 /100k
2 Louisiana 2,195 /100k
3 Nebraska 2,151 /100k
4 Vermont 1,939 /100k
5 Oklahoma 1,934 /100k
6 Texas 1,749 /100k
7 South Dakota 1,319 /100k
8 West Virginia 1,162 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1000 tablets this page58657-0648-10 41,092 Rx · $307,247
500 tablets58657-0648-50 2,486 Rx · $24,978
100 tablets58657-0648-01 477 Rx · $4,348
Drug total (last 4 qtrs): 44,055 Rx · 1,971,219 units · $336,573 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
← 58657-0647-01 · Method 58657-0649-01 · Method →
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.