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Midodrine Hydrochloride 2.5 mg Tablet, 100-count — NDC 64980-0433-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Midodrine Hydrochloride 2.5 mg Tablet, 100-count — NDC 64980-433-01 (Billing 64980-0433-01)

by Rising Pharma Holdings, Inc. · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Midodrine Hydrochloride 2.5 mg Tablet from Rising Pharma Holdings, Inc., marketed since Apr 2019 and currently FDA-listed; retail pharmacies pay about $0.0737 per tablet (NADAC). It is this product's only package size.

NDC 64980-0433-01
🏷️ FDA NDC (as labeled) 64980-433-01 billing pads the product segment with a zero
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 →
⚠️
Other active recalls for Midodrine 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 · Feb 17, 2026 — Defective container; inadequately sealed blister packaging. (The Harvard Drug Group LLC) · FDA recall D-0383-2026
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) 64980-433-01
Product NDC 64980-433
11-digit billing NDC 64980043301
NCPDP billing unit EA — each (per item)
RxCUI 993462, 993466, 993470
UNII 59JV96YTXV
UPC 0364980435017, 0364980433013, 0364980434010
Application # ANDA207613
SPL Set ID ffd4dfb9-a6d8-4c81-8b8c-8228d9e2f93e
Established class (EPC) alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-04-01
Route ORAL
Dosage form TABLET
Substance MIDODRINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 38000083100320
GPI class Midodrine HCl
GCN Seq No 017118
GCN 28322
HICL code 015908
Ingredient (HICL) Midodrine Hcl
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J5
Therapeutic class — intermediate (HIC2) Adrenergics
HIC3 code J5H
Therapeutic class — specific (HIC3) Adrenergic Vasopressor Agents
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name MIDODRINE HCL 2.5 MG TABLET
FDB brand name Midodrine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 017118
  • GCN: 28322
  • GPI-14 (Medi-Span): 38000083100320
  • HICL (First Databank): 015908
  • AHFS class code: 12:12.04.00
  • RxCUI (RxNorm): 993462
Why two NDCs? The FDA registers this code as 64980-433-01 — 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 → 64980-0433-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the alpha-Adrenergic Agonist class.

Pharmacologic class alpha-Adrenergic Agonist
Drug family (ATC) Adrenergic and dopaminergic agents
How it works Adrenergic alpha-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 MIDODRINE HCL 2.5 MG TABLET Ingredient Midodrine Hcl
📗 Our plain-language guide HelloPharmacist
  • It treats symptomatic orthostatic hypotension, where your blood pressure drops when you stand and you feel dizzy or light-headed. It is meant for people who still struggle after tr...
  • Take it during the daytime when you will be upright, usually spaced a few hours apart. Your last dose should be no later than 6 P.M. and at least 4 hours before bed. This helps low...
  • Tingling or itching of the scalp, goosebumps, chills and needing to urinate more often or urgently are common. These come from how the drug acts on the body's receptors. Call your...
  • Midodrine can raise your blood pressure a lot when you are lying flat. That can raise your risk of stroke if it goes uncontrolled. Regular checks help your doctor decide whether to...
📖 Read our full Midodrine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.074 $7.37 / 100 tablets
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 $0.2074 $20.74 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.223 $0.070
▼ Down 66% over the last 24 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 Marketing startMarketing endStatus
64980-0433-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2019-04-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Midodrine Hydrochloride 2.5 mg 00378-1901-01 Mylan 100 tablets $0.074 AB Availability likely —
Midodrine Hydrochloride 2.5 mg 00904-6817-06 Major 50 tablets $0.074 AB Availability likely —
Midodrine Hydrochloride 2.5 mg 49884-0814-01 Par 100 tablets $0.074 AB Availability likely —
Midodrine Hydrochloride 2.5 mg 50268-0561-15 AvPAK 50 tablets $0.074 AB Availability likely —
Midodrine Hydrochloride 2.5 mg 52817-0323-10 TruPharma, 100 tablets $0.074 AB Availability likely —
Midodrine Hydrochloride 2.5 mg 59651-0246-01 Aurobindo 100 tablets $0.074 AB Availability likely —
Midodrine Hydrochloride 2.5 mg 60505-1320-01 Apotex 100 tablets $0.074 AB Availability likely —
Midodrine Hydrochloride 2.5 mg 60687-0387-01 American 100 tablets $0.074 AB Availability likely —
Midodrine Hydrochloride 2.5 mg 62332-0338-31 Alembic 100 tablets $0.074 AB Availability likely —
Midodrine Hydrochloride 2.5 mgthis 64980-0433-01 Rising 100 tablets $0.074 AB Availability likely —
Midodrine hydrochloride 2.5 mg 68382-0737-01 Zydus 100 tablets $0.074 AB Availability likely —
Midodrine Hydrochloride 2.5 mg 70700-0157-01 Xiromed, 100 tablets $0.074 AB Availability likely —
Midodrine Hydrochloride 2.5 mg 70756-0010-11 Lifestar 100 tablets $0.074 AB Availability likely —
Midodrine Hydrochloride 2.5 mg 72603-0605-01 NorthStar 100 tablets $0.074 AB Availability likely —
Midodrine Hydrochloride 2.5 mg 72603-0906-05 NorthStar 50 tablets $0.074 AB Availability likely —
Midodrine Hydrochloride 2.5 mg 72888-0112-01 Advagen 100 tablets $0.074 AB Availability likely —
Midodrine Hydrochloride 2.5 mg 82293-0003-10 Novugen 100 tablets $0.074 AB Availability likely —
Midodrine Hydrochloride 2.5 mg 00245-0211-01 Upsher-Smith 100 tablets — AB FDA listed —
Midodrine Hydrochloride 2.5 mg 00615-8382-39 NCS 30 tablets — AB FDA listed —
Midodrine Hydrochloride 2.5 mg 23155-0969-01 Avet 100 tablets — AB FDA listed —
Midodrine Hydrochloride 2.5 mg 42291-0560-90 AvKARE 90 tablets — AB FDA listed —
Midodrine Hydrochloride 2.5 mg 46708-0338-31 Alembic 100 tablets — AB FDA listed —
Midodrine Hydrochloride 2.5 mg 51407-0388-90 Golden 90 tablets — AB FDA listed —
Midodrine Hydrochloride 2.5 mg 63629-2227-01 Bryant 100 tablets — AB FDA listed —
Midodrine Hydrochloride 2.5 mg 63629-2348-01 Bryant 100 tablets — AB FDA listed —
Midodrine hydrochloride 2.5 mg 70771-1595-01 Zydus 100 tablets — AB FDA listed —
Midodrine Hydrochloride 2.5 mg 71205-0904-00 Proficient 100 tablets — AB FDA listed —
Midodrine Hydrochloride 2.5 mg 71335-3037-01 Bryant 100 tablets — AB FDA listed —
Midodrine Hydrochloride 2.5 mg 72162-1517-01 Bryant 100 tablets — AB FDA listed —
Midodrine Hydrochloride 2.5 mg 72162-1973-01 Bryant 100 tablets — AB FDA listed —
Midodrine Hydrochloride 2.5 mg 72162-2560-01 Bryant 100 tablets — AB FDA listed —
Midodrine Hydrochloride 2.5 mg 72789-0465-01 PD-Rx 100 tablets — AB FDA listed —
Midodrine Hydrochloride 2.5 mg 81469-0139-90 First 90 tablets — AB FDA listed —
Midodrine Hydrochloride 2.5 mg 85293-0005-01 Umasuto, 100 tablets — AB FDA listed —
Midodrine Hydrochloride 2.5 mg 00904-7640-06 Major 50 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
Apr 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
ShapeRound
ImprintP;235
Size1 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerRising Pharma Holdings, Inc.
Application holderUNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD
FDA applicationANDA207613 (ANDA)
Labeler code64980
First marketedApr 2019
Product typeHuman Prescription Drug
Portfolio525 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.
🚨 Boxed Warning 94 words ▾

Warning: Because midodrine can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use of midodrine in the treatment of symptomatic orthostatic hypotension is based primarily on a change in a surrogate marker of effectiveness, an increase in systolic blood pressure measured one minute after standing, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine, principally improved ability to carry out activities of daily living, have not been verified.

🎯 Indications and Usage 142 words ▾

INDICATIONS AND USAGE Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP > 200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit.

At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION The recommended dose of midodrine hydrochloride tablets is 10 mg, 3 times daily. Dosing should take place during the daytime hours when the patient needs to be upright, pursuing the activities of daily living. A suggested dosing schedule of approximately 4-hour intervals is as follows: shortly before, or upon arising in the morning, midday and late afternoon (not later than 6 P.M.).

Doses may be given in 3-hour intervals, if required, to control symptoms, but not more frequently. Single doses as high as 20 mg have been given to patients, but severe and persistent systolic supine hypertension occurs at a high rate (about 45%) at this dose. In order to reduce the potential for supine hypertension during sleep, midodrine hydrochloride tablets should not be given after the evening meal or less than 4 hours before bedtime.

Total daily doses greater than 30 mg have been tolerated by some patients, but their safety and usefulness have not been studied systematically or established. Because of the risk of supine hypertension, midodrine hydrochloride tablets should be continued only in patients who appear to attain symptomatic improvement during initial treatment. The supine and standing blood pressure should be monitored regularly, and the administration of midodrine hydrochloride tablets should be stopped if supine blood pressure increases excessively.

Because desglymidodrine is excreted renally, dosing in patients with abnormal renal function should be cautious; although this has not been systematically studied, it is recommended that treatment of these patients be initiated using 2.5-mg doses. Dosing in children has not been adequately studied. Blood levels of midodrine and desglymidodrine were similar when comparing levels in patients 65 or older vs. younger than 65 and when comparing males vs. females, suggesting dose modifications for these groups are not necessary.

⛔ Contraindications 36 words ▾

CONTRAINDICATIONS Midodrine hydrochloride tablets are contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. Midodrine hydrochloride tablets should not be used in patients with persistent and excessive supine hypertension.

⚠️ Warnings 131 words ▾

WARNINGS Supine Hypertension: The most potentially serious adverse reaction associated with midodrine therapy is marked elevation of supine arterial blood pressure (supine hypertension). Systolic pressure of about 200 mmHg were seen overall in about 13.4% of patients given 10 mg of midodrine. Systolic elevations of this degree were most likely to be observed in patients with relatively elevated pre-treatment systolic blood pressures (mean 170 mmHg).

There is no experience in patients with initial supine systolic pressure above 180 mmHg, as those patients were excluded from the clinical trials. Use of midodrine in such patients is not recommended. Sitting blood pressures were also elevated by midodrine therapy.

It is essential to monitor supine and sitting blood pressures in patients maintained on midodrine. Uncontrolled hypertension increases the risk of cardiovascular events, particularly stroke.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS The most frequent adverse reactions seen in controlled trials were supine and sitting hypertension; paresthesia and pruritus, mainly of the scalp; goosebumps; chills; urinary urge; urinary retention and urinary frequency. The frequency of these events in a 3-week placebo-controlled trial is shown in the following table: Adverse Events Placebo n = 88 Midodrine n = 82 Event # of reports % of patients # of reports % of patients Total # of reports 22 77 Paresthesia 1 4 4.5 15

18.3 Piloerection 0 0 11

13.4 Dysuria 2 0 0 11

13.4Pruritus 3 2 2.3 10

12.2 Supine hypertension 4 0 0 6

7.3 Chills 0 0 4

4.9 Pain 5 0 0 4

4.9Rash 1 1.1 2 2.4 1 Includes hyperesthesia and scalp paresthesia 2 Includes dysuria (1), increased urinary frequency (2), impaired urination (1), urinary retention (5), urinary urgency (2) 3 Includes scalp pruritus 4 Includes patients who experienced an increase in supine hypertension 5 Includes abdominal pain and pain increase Less frequent adverse reactions were headache; feeling of pressure/fullness in the head; vasodilation/flushing face; confusion/thinking abnormality; dry mouth; nervousness/anxiety and rash.

Other adverse reactions that occurred rarely were visual field defect; dizziness; skin hyperesthesia; insomnia; somnolence; erythema multiforme; canker sore; dry skin; dysuria; impaired urination; asthenia; backache; pyrosis; nausea; gastrointestinal distress; flatulence and leg cramps. The most potentially serious adverse reaction associated with midodrine therapy is supine hypertension. The feelings of paresthesia, pruritus, piloerection and chills are pilomotor reactions associated with the action of midodrine on the alpha-adrenergic receptors of the hair follicles.

Feelings of urinary urgency, retention and frequency are associated with the action of midodrine on the alpha-receptors of the bladder neck. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 173 words ▾

OVERDOSAGE Symptoms of overdose could include hypertension, piloerection (goosebumps), a sensation of coldness and urinary retention. There are 2 reported cases of overdosage with midodrine, both in young males. One patient ingested midodrine drops, 250 mg, experienced systolic blood pressure greater than 200 mmHg, was treated with an IV injection of 20 mg of phentolamine, and was discharged the same night without any complaints.

The other patient ingested 205 mg of midodrine (41 5-mg tablets), and was found lethargic and unable to talk, unresponsive to voice but responsive to painful stimuli, hypertensive and bradycardic. Gastric lavage was performed, and the patient recovered fully by the next day without sequelae. The single doses that would be associated with symptoms of overdosage or would be potentially life-threatening are unknown.

The oral LD 50 is approximately 30 to 50 mg/kg in rats, 675 mg/kg in mice, and 125 to 160 mg/kg in dogs. Desglymidodrine is dialyzable. Recommended general treatment, based on the pharmacology of the drug, includes induced emesis and administration of alpha-sympatholytic drugs (e.g., phentolamine).

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action: Midodrine forms an active metabolite, desglymidodrine, that is an alpha 1 -agonist, and exerts its actions via activation of the alpha-adrenergic receptors of the arteriolar and venous vasculature, producing an increase in vascular tone and elevation of blood pressure. Desglymidodrine does not stimulate cardiac beta-adrenergic receptors. Desglymidodrine diffuses poorly across the blood-brain barrier, and is therefore not associated with effects on the central nervous system.

Administration of midodrine results in a rise in standing, sitting, and supine systolic and diastolic blood pressure in patients with orthostatic hypotension of various etiologies. Standing systolic blood pressure is elevated by approximately 15 to 30 mmHg at 1 hour after a 10-mg dose of midodrine, with some effect persisting for 2 to 3 hours. Midodrine has no clinically significant effect on standing or supine pulse rates in patients with autonomic failure.

Pharmacokinetics: Midodrine is a prodrug, i.e., the therapeutic effect of orally administered midodrine is due to the major metabolite desglymidodrine, formed by deglycination of midodrine. After oral administration, midodrine is rapidly absorbed. The plasma levels of the prodrug peak after about half an hour, and decline with a half-life of approximately 25 minutes, while the metabolite reaches peak blood concentrations about 1 to 2 hours after a dose of midodrine and has a half-life of about 3 to 4 hours.

The absolute bioavailability of midodrine (measured as desglymidodrine) is 93%. The bioavailability of desglymidodrine is not affected by food. Approximately the same amount of desglymidodrine is formed after intravenous and oral administration of midodrine.

Neither midodrine nor desglymidodrine is bound to plasma proteins to any significant extent. Metabolism and Excretion: Thorough metabolic studies have not been conducted, but it appears that deglycination of midodrine to desglymidodrine takes place in many tissues, and both compounds are metabolized in part by the liver. Neither midodrine nor desglymidodrine is a substrate for monoamine oxidase.

Renal elimination of midodrine is insignificant. The renal clearance of desglymidodrine is of the order of 385 mL/minute, most, about 80%, by active renal secretion. The actual mechanism of active secretion has not been studied, but it is possible that it occurs by the base-secreting pathway responsible for the secretion of several other drugs that are bases (see also Potential for Drug Interactions ).

Clinical Studies Midodrine has been studied in 3 principal controlled trials, one of 3-weeks duration and 2 of 1 to 2 days duration. All studies were randomized, double-blind and parallel-design trials in patients with orthostatic hypotension of any etiology and supine-to-standing fall of systolic blood pressure of at least 15 mmHg accompanied by at least moderate dizziness/light-headedness. Patients with pre-existing sustained supine hypertension above 180/110 mmHg were routinely excluded.

In a 3-week study in 170 patients, most previously untreated with midodrine, the midodrine-treated patients (10 mg t.i.d., with the last dose not later than 6 P.M.) had significantly higher (by about 20 mmHg) 1-minute standing systolic pressure 1 hour after dosing (blood pressures were not measured at other times) for all 3 weeks. After week 1, midodrine-treated patients had small improvements in dizziness/lightheadedness/ unsteadiness scores and global evaluations, but these effects were made difficult to interpret by a high early drop-out rate (about 25% vs 5% on placebo).

Supine and sitting blood pressure rose 16/8 and 20/10 mmHg, respectively, on average. In a 2-day study, after open-label midodrine, known midodrine responders received midodrine 10 mg or placebo at 0, 3, and 6 hours. One-minute standing systolic blood pressures were increased 1 hour after each dose by about 15 mmHg and 3 hours after each dose by about 12 mm… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 179 words ▾

HOW SUPPLIED 2.5-mg, 5-mg and 10-mg tablets for oral administration. The 2.5-mg tablets are white to off-white, round, flat, scored tablets debossed with “P” above the score on one side of the tablet & “233” on the other side. They are available as follows: Bottles of 100 : NDC 64980-433-01 The 5-mg tablets are white to off-white, round, flat, scored tablets debossed with “P” above the score on one side of the tablet & “234” on the other side.

They are available as follows: Bottles of 100 : NDC 64980-434-01 The 10-mg tablets are white to off-white, round, flat, scored tablets debossed with “P” above the score on one side of the tablet & “235” on the other side. They are available as follows: Bottles of 100 : NDC 64980-435-01 Store at 25°C (77°F) Excursions permitted to 15-30˚C (59-86˚F) [see USP Controlled Room Temperature] Rx only Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J. B.

Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 141694 May 2025 Rising logo

📋 Description 115 words ▾

DESCRIPTION Name: Midodrine Hydrochloride Tablets Dosage Form: 2.5-mg, 5-mg and 10-mg tablets for oral administration Active Ingredient: Midodrine hydrochloride, 2.5 mg, 5 mg and 10 mg Inactive Ingredients: Colloidal Silicon Dioxide NF, Croscarmellose Sodium NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, Pregelatinized Starch NF and Sodium Lauryl Sulfate NF. Pharmacological Classification: Vasopressor/Antihypotensive Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl) acetamide monohydrochloride BAN, INN, JAN: Midodrine Structural formula: Molecular formula: C 12 H 18 N 2 O 4 HCl; Molecular Weight: 290.7 Organoleptic Properties: White to off-white powder Solubility: Water: Soluble Methanol: Sparingly soluble pKa: 7.8 (0.3% aqueous solution) pH: 3.5 to 5.5 (5% aqueous solution) Melting Range: 200 to 203°C structure-midodrine

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General: The potential for supine and sitting hypertension should be evaluated at the beginning of midodrine therapy. Supine hypertension can often be controlled by preventing the patient from becoming fully supine, i.e., sleeping with the head of the bed elevated. The patient should be cautioned to report symptoms of supine hypertension immediately.

Symptoms may include cardiac awareness, pounding in the ears, headache, blurred vision, etc. The patient should be advised to discontinue the medication immediately if supine hypertension persists. Blood pressure should be monitored carefully when midodrine is used concomitantly with other agents that cause vasoconstriction, such as phenylephrine, ephedrine, dihydroergotamine, phenylpropanolamine, or pseudoephedrine.

A slight slowing of the heart rate may occur after administration of midodrine, primarily due to vagal reflex. Caution should be exercised when midodrine is used concomitantly with cardiac glycosides (such as digitalis), psychopharmacologic agents, beta-blockers or other agents that directly or indirectly reduce heart rate. Patients who experience any signs or symptoms suggesting bradycardia (pulse slowing, increased dizziness, syncope, cardiac awareness) should be advised to discontinue midodrine and should be re-evaluated.

Midodrine should be used cautiously in patients with urinary retention problems, as desglymidodrine acts on the alpha-adrenergic receptors of the bladder neck. Midodrine should be used with caution in orthostatic hypotensive patients who are also diabetic, as well as those with a history of visual problems who are also taking fludrocortisone acetate, which is known to cause an increase in intraocular pressure and glaucoma. Midodrine use has not been studied in patients with renal impairment.

Because desglymidodrine is eliminated via the kidneys, and higher blood levels would be expected in such patients, midodrine should be used with caution in patients with renal impairment, with a starting dose of 2.5 mg (see DOSAGE AND ADMINISTRATION ). Renal function should be assessed prior to initial use of midodrine. Midodrine use has not been studied in patients with hepatic impairment.

Midodrine should be used with caution in patients with hepatic impairment, as the liver has a role in the metabolism of midodrine. Information for Patients: Patients should be told that certain agents in over-the-counter products, such as cold remedies and diet aids, can elevate blood pressure, and therefore, should be used cautiously with midodrine, as they may enhance or potentiate the pressor effects of midodrine (see Drug Interactions ). Patients should also be made aware of the possibility of supine hypertension.

They should be told to avoid taking their dose if they are to be supine for any length of time, i.e., they should take their last daily dose of midodrine 3 to 4 hours before bedtime to minimize nighttime supine hypertension. Laboratory Tests: Since desglymidodrine is eliminated by the kidneys and the liver has a role in its metabolism, evaluation of the patient should include assessment of renal and hepatic function prior to initiating therapy and subsequently, as appropriate. Drug Interactions : When administered concomitantly with midodrine, cardiac glycosides may enhance or precipitate bradycardia, A.V. block or arrhythmia.

The risk of hypertension increases with concomitant administration of drugs that increase blood pressure (phenylephrine, pseudoephedrine, ephedrine, dihydroergotamine, thyroid hormones, or droxidopa). Avoid concomitant use of drugs that increase blood pressure. If concomitant use cannot be avoided, monitor blood pressure closely.

Avoid use of MAO inhibitors or linezolid with midodrine. Midodrine has been used in patients concomitantly treated with salt-retaining steroid therapy (i.e., fludrocortisone acetate), with or without salt supplementation. The potential for supine hypertension should be carefully monitored in these pa… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 46 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Rising NDC 64980-433-01 Midodrine Hydrochloride Tablets USP 2.5 mg 100 Tablets Rx only Rising NDC 64980-434-01 Midodrine Hydrochloride Tablets USP 5 mg 100 Tablets Rx only Rising NDC 64980-435-01 Midodrine Hydrochloride Tablets USP 10 mg 100 Tablets Rx only Midodrine-HCl-Tablets-USP-2-5mg-100ct Midodrine-HCl-Tablets-USP-5mg-100ct Midodrine-HCl-Tablets-USP-10mg-100ct

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