Home › NDC Lookup › Ingredients › Midodrine Hydrochloride › 71205-0905-90
Midodrine Hydrochloride 5 mg Tablet, 90-count — NDC 71205-0905-90 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Midodrine Hydrochloride 5 mg Tablet, 90-count — NDC 71205-905-90 (Billing 71205-0905-90)

by Proficient Rx LP · 90 TABLET in 1 BOTTLE, PLASTIC

This is a package of 90 tablets of Midodrine Hydrochloride 5 mg Tablet from Proficient Rx LP, marketed since Oct 2020 and currently FDA-listed.

NDC 71205-0905-90
🏷️ FDA NDC (as labeled) 71205-905-90 billing pads the product segment with a zero
This package
Contains90-count Pack sizes7 compare ↓
Also priced by: Part D plans $0.2074/unit — full pricing hub ↓
Product page 71205-0905-00 Also comes in: 30 tablets 71205-905-30 60 tablets 71205-905-60 100 tablets 71205-905-00 120 tablets 71205-905-72 500 tablets 71205-905-55 1000 tablets 71205-905-11
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

⚠️
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) 71205-905-90
Product NDC 71205-905
11-digit billing NDC 71205090590
NCPDP billing unit EA — each (per item)
RxCUI 993462, 993466, 993470
UNII 59JV96YTXV
UPC 0371205906306, 0371205905309, 0371205904302
Application # ANDA207849
SPL Set ID 0aebf5f9-8cfa-4b77-ba40-821ce0a2b266
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 2020-10-15
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 38000083100330
GPI class Midodrine HCl
GCN Seq No 017117
GCN 28321
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 5 MG TABLET
FDB brand name Midodrine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 017117
  • GCN: 28321
  • GPI-14 (Medi-Span): 38000083100330
  • HICL (First Databank): 015908
  • AHFS class code: 12:12.04.00
  • RxCUI (RxNorm): 993462
Why two NDCs? The FDA registers this code as 71205-905-90 — 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 → 71205-0905-90. 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 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 →

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 · Q2 2026 $0.2074 $18.67 / 90 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71205-0905-00 71205-905-00 Main listing 100 TABLET in 1 BOTTLE, PLASTIC 2021-07-20 — Active
71205-0905-11 71205-905-11 1000 TABLET in 1 BOTTLE, PLASTIC 2021-07-20 — Active
71205-0905-30 71205-905-30 30 TABLET in 1 BOTTLE, PLASTIC 2021-07-20 — Active
71205-0905-55 71205-905-55 500 TABLET in 1 BOTTLE, PLASTIC 2021-07-20 — Active
71205-0905-60 71205-905-60 60 TABLET in 1 BOTTLE, PLASTIC 2021-07-20 — Active
71205-0905-72 71205-905-72 120 TABLET in 1 BOTTLE, PLASTIC 2021-07-20 — Active
71205-0905-90 You're viewing this 90 TABLET in 1 BOTTLE, PLASTIC 2021-07-20 — Active

You're viewing one of 7 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 90-count package — 90 tablet in 1 bottle, plastic.
How does this package differ from NDC 71205-0905-30?
Both are Midodrine Hydrochloride 5 mg Tablet — the drug itself is identical. This page's package is the 90-count one, while NDC 71205-0905-30 is the 30 tablets package.
What NDC number is used to bill for this package of Midodrine Hydrochloride 5 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Midodrine Hydrochloride 5 mg 00245-0212-01 Upsher-Smith 100 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 00378-1902-01 Mylan 100 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 00904-6818-06 Major 50 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 49884-0849-01 Par 100 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 50268-0562-15 AvPAK 50 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 51079-0453-20 Mylan 100 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 52817-0324-10 TruPharma, 100 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 59651-0247-01 Aurobindo 100 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 60505-1321-01 Apotex 100 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 60687-0398-01 American 100 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 62332-0339-31 Alembic 100 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 64980-0434-01 Rising 100 tablets $0.111 AB Availability likely —
Midodrine hydrochloride 5 mg 68382-0738-01 Zydus 100 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 70700-0158-01 Xiromed, 100 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 70756-0049-11 Lifestar 100 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 72603-0606-01 NorthStar 100 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 72603-0907-05 NorthStar 50 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 72888-0113-01 Advagen 100 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 82293-0004-10 Novugen 100 tablets $0.111 AB Availability likely —
Midodrine Hydrochloride 5 mg 00615-8383-39 NCS 30 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 23155-0970-01 Avet 100 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 42291-0561-90 AvKARE 90 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 46708-0339-31 Alembic 100 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 48433-0075-20 Safecor 100 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 51407-0389-90 Golden 90 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 55154-5623-00 Cardinal 10 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 55154-5696-00 Cardinal 10 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 55154-8086-00 Cardinal 10 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 63629-2347-01 Bryant 100 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 67046-1512-03 Coupler 30 tablets — AB FDA listed —
Midodrine hydrochloride 5 mg 70771-1596-01 Zydus 100 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mgthis 71205-0905-90 Proficient 90 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 71335-1433-01 Bryant 30 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 71335-1705-01 Bryant 30 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 71335-2171-01 Bryant 30 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 72162-1974-01 Bryant 100 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 72162-2561-01 Bryant 100 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 72789-0468-01 PD-Rx 100 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 81469-0140-90 First 90 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 85293-0006-01 Umasuto, 100 tablets — AB FDA listed —
Midodrine Hydrochloride 5 mg 00904-7641-06 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

🏛️
2020
On the market since
Oct 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 White
ShapeRound
ImprintC;151
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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 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.

3 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

LabelerProficient Rx LP
Application holderXIROMED PHARMA ESPANA SL
FDA applicationANDA207849 (ANDA)
Labeler code71205
First marketedOct 2020
Product typeHuman Prescription Drug
Portfolio1,729 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 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 100 words ▾

WARNING Because midodrine hydrochloride tablets 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 hydrochloride tablets 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 hydrochloride tablets, 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' 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 life. 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 138 words ▾

WARNINGS Supine Hypertension The most potentially serious adverse reaction associated with midodrine hydrochloride tablets therapy is marked elevation of supine arterial blood pressure (supine hypertension). Systolic pressures of about 200 mmHg were seen overall in about 13.4% of patients given 10 mg of midodrine hydrochloride tablets. 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 hydrochloride tablets in such patients is not recommended. Sitting blood pressures were also elevated by midodrine hydrochloride tablets 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 Includes hyperesthesia and scalp paresthesia 4 4.5 15

18.3 Piloerection 0 0 11

13.4Dysuria Includes dysuria (1), increased urinary frequency (2), impaired urination (1), urinary retention (5), urinary urgency (2) 0 0 11

13.4Pruritus Includes scalp pruritus 2 2.3 10

12.2Supine hypertension Includes patients who experienced an increase in supine hypertension 0 0 6

7.3 Chills 0 0 4

4.9 Pain Includes abdominal pain and pain increase 0 0 4

4.9Rash 1 1.1 2

2.4Less 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 hydrochloride tablets 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.

🔄 Drug Interactions 147 words ▾

Drug Interactions When administered concomitantly with midodrine hydrochloride tablets, 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 hydrochloride tablets 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 patients and may be minimized by either reducing the dose of fludrocortisone acetate or decreasing the salt intake prior to initiation of treatment with midodrine hydrochloride tablets. Alpha-adrenergic blocking agents, such as prazosin, terazosin, and doxazosin, can antagonize the effects of midodrine hydrochloride tablets.

🤰 Pregnancy 91 words ▾

Pregnancy Pregnancy Category C Midodrine hydrochloride tablets increased the rate of embryo resorption, reduced fetal body weight in rats and rabbits, and decreased fetal survival in rabbits when given in doses 13 (rat) and 7 (rabbit) times the maximum human dose based on body surface area (mg/m 2 ). There are no adequate and well-controlled studies in pregnant women. Midodrine hydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

No teratogenic effects have been observed in studies in rats and rabbits.

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🆘 Overdosage 180 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 hydrochloride tablets, both in young males. One patient ingested midodrine hydrochloride drops, 250 mg, experienced systolic blood pressure of 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 hydrochloride (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 hydrochloride tablets form 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 hydrochloride tablets 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 mmHg to 30 mmHg at 1 hour after a 10 mg dose of midodrine, with some effect persisting for 2 to 3 hours. Midodrine hydrochloride tablets have no clinically significant effect on standing or supine pulse rates in patients with autonomic failure.

Pharmacokinetics Midodrine hydrochloride tablets are 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 hydrochloride tablets are 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 PRECAUTIONS: 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 preexisting 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/light-headedness/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 mmHg 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… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 148 words ▾

Mechanism of Action Midodrine hydrochloride tablets form 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 hydrochloride tablets 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 mmHg to 30 mmHg at 1 hour after a 10 mg dose of midodrine, with some effect persisting for 2 to 3 hours. Midodrine hydrochloride tablets have no clinically significant effect on standing or supine pulse rates in patients with autonomic failure.

📦 How Supplied / Storage and Handling ~1 min read ▾

HOW SUPPLIED Midodrine Hydrochloride Tablets, USP are available containing 2.5 mg, 5 mg or 10 mg of midodrine hydrochloride, USP. The 2.5 mg tablets are round, white scored tablet with C/149 on the upper side; and plain on the lower side. They are available as follows: NDC 71205-904-30 Bottle of 30 Tablets NDC 71205-904-60 Bottle of 60 Tablets NDC 71205-904-90 Bottle of 90 Tablets NDC 71205-904-00 Bottle of 100 Tablets NDC 71205-904-72 Bottle of 120 Tablets NDC 71205-904-55 Bottle of 500 Tablets NDC 71205-904-11 Bottle of 1000 Tablets The 5 mg are tablets round, white scored tablet with C/150 on the upper side; and plain on the lower side.

They are available as follows: NDC 71205-905-30 Bottle of 30 Tablets NDC 71205-905-60 Bottle of 60 Tablets NDC 71205-905-90 Bottle of 90 Tablets NDC 71205-905-00 Bottle of 100 Tablets NDC 71205-905-72 Bottle of 120 Tablets NDC 71205-905-55 Bottle of 500 Tablets NDC 71205-905-11 Bottle of 1000 Tablets The 10 mg tablets are round, white scored tablet with C/151 on the upper side; and plain on the lower side. They are available as follows: NDC 71205-906-30 Bottle of 30 Tablets NDC 71205-906-60 Bottle of 60 Tablets NDC 71205-906-90 Bottle of 90 Tablets NDC 71205-906-00 Bottle of 100 Tablets NDC 71205-906-72 Bottle of 120 Tablets NDC 71205-906-55 Bottle of 500 Tablets NDC 71205-906-11 Bottle of 1000 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured for: Xiromed, LLC. Florham Park, NJ 07932 Repackaged and Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 PI-159-00 Rev.: 07/2019

📋 Description 119 words ▾

DESCRIPTION Midodrine hydrochloride is a vasopressor/antihypotensive. The chemical name for midodrine hydrochloride is acetamide, 2-amino- N -[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]-, monohydrochloride, (±)-. The molecular weight of midodrine hydrochloride is 290.7.

Its structural formula and molecular formula are: Midodrine hydrochloride, USP is an odorless, white, crystalline powder. It is soluble in water and sparingly soluble in methanol and has a pKa of 7.8 (0.3% aqueous solution) and a pH of 3.5 to 5.5 (5% aqueous solution). It has a melting range of 200° to 203°C.

Each midodrine hydrochloride tablet, USP for oral administration contains 2.5 mg, 5 mg or 10 mg of midodrine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Structural Formula

💬 Information for Patients 106 words ▾

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 hydrochloride tablets, as they may enhance or potentiate the pressor effects of midodrine hydrochloride tablets (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 hydrochloride tablets 3 to 4 hours before bedtime to minimize nighttime supine hypertension.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General The potential for supine and sitting hypertension should be evaluated at the beginning of midodrine hydrochloride tablets 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 hydrochloride tablets are 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 hydrochloride tablets, primarily due to vagal reflex. Caution should be exercised when midodrine hydrochloride tablets are 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 hydrochloride tablets and should be reevaluated.

Midodrine hydrochloride tablets should be used cautiously in patients with urinary retention problems, as desglymidodrine acts on the alpha-adrenergic receptors of the bladder neck. Midodrine hydrochloride tablets 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 hydrochloride tablets 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 hydrochloride tablets 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 hydrochloride tablets. Midodrine hydrochloride tablets use has not been studied in patients with hepatic impairment.

Midodrine hydrochloride tablets 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 hydrochloride tablets, as they may enhance or potentiate the pressor effects of midodrine hydrochloride tablets (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 hydrochloride tablets 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 hydrochloride tablets, 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 cann… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 36 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when midodrine hydrochloride tablets is administered to a nursing woman.

🧬 Pharmacokinetics ~1 min read ▾

Pharmacokinetics Midodrine hydrochloride tablets are 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 hydrochloride tablets are 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 PRECAUTIONS: Potential for Drug Interactions ).

🔬 Clinical Studies ~2 min read ▾

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 preexisting 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/light-headedness/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 mmHg 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 mmHg; 3-minute standing pressures were increased also at 1, but not 3, hours after dosing. There were increases in standing time seen intermittently 1 hour after dosing, but not at 3 hours. In a 1-day, dose-response trial, single doses of 0 mg, 2.5 mg, 10 mg, and 20 mg of midodrine were given to 25 patients.

The 10 mg and 20 mg doses produced increases in standing 1-minute systolic pressure of about 30 mmHg at 1 hour; the increase was sustained in part for 2 hours after 10 mg and 4 hours after 20 mg. Supine systolic pressure was ≥ 200 mmHg in 22% of patients on 10 mg and 45% of patients on 20 mg; elevated pressures often lasted 6 hours or more.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 87 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies have been conducted in rats and mice at dosages of 3 to 4 times the maximum recommended daily human dose on a mg/m 2 basis, with no indication of carcinogenic effects related to midodrine hydrochloride tablets. Studies investigating the mutagenic potential of midodrine hydrochloride tablets revealed no evidence of mutagenicity. Other than the dominant lethal assay in male mice, where no impairment of fertility was observed, there have been no studies on the effects of midodrine hydrochloride tablets on fertility.

📄 Package Label / Principal Display Panel 48 words ▾

PRINCIPAL DISPLAY PANEL NDC 71205-904-30 Midodrine Hydrochloride Tablets, USP 2.5 mg Rx only 30 Tablets 71205-904-30

PRINCIPAL DISPLAY PANEL NDC 71205-905-30 Midodrine Hydrochloride Tablets, USP 5 mg Rx only 30 Tablets 71205-905-30

PRINCIPAL DISPLAY PANEL NDC 71205-906-30 Midodrine Hydrochloride Tablets, USP 10 mg Rx only 30 Tablets 71205-906-30

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 Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 6 other package presentations of this same product, including 30 tablets (71205-0905-30), 60 tablets (71205-0905-60), 100 tablets (71205-0905-00). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Proficient Rx LP 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.
← 71205-0904-00 · Proficient 71205-0906-00 · Proficient →
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.