NDC 53217-232 Hydrochlorothiazide

NDC Product Code 53217-232

NDC CODE: 53217-232

Proprietary Name: Hydrochlorothiazide What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Hydrochlorothiazide belongs to a class of drugs known as diuretics/"water pills." It works by causing you to make more urine. This helps your body get rid of extra salt and water. This medication also reduces extra fluid in the body (edema) caused by conditions such as heart failure, liver disease, or kidney disease. This can lessen symptoms such as shortness of breath or swelling in your ankles or feet.

Product Characteristics

Color(s):
YELLOW (C48330 - PEACH)
Shape: ROUND (C48348)
Size(s):
6 MM
Imprint(s):
EP;131
Score: 2

NDC Code Structure

NDC 53217-232-00

Package Description: 100 TABLET in 1 BOTTLE

NDC 53217-232-14

Package Description: 14 TABLET in 1 BOTTLE, PLASTIC

NDC 53217-232-30

Package Description: 30 TABLET in 1 BOTTLE, PLASTIC

NDC 53217-232-60

Package Description: 60 TABLET in 1 BOTTLE

NDC 53217-232-90

Package Description: 90 TABLET in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Hydrochlorothiazide with NDC 53217-232 is a product labeled by Aidarex Pharmaceuticals Llc. The generic name of Hydrochlorothiazide is . The product's dosage form is and is administered via form.

Labeler Name: Aidarex Pharmaceuticals Llc

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Aidarex Pharmaceuticals Llc
Labeler Code: 53217
Start Marketing Date: 03-01-2007 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Hydrochlorothiazide

Hydrochlorothiazide is pronounced as (hye'' droe klor'' oh thye' a zide)

Why is hydrochlorothiazide medication prescribed?
Hydrochlorothiazide is used alone or in combination with other medications to treat high blood pressure. Hydrochlorothiazide is used to treat edema (fluid retention; exce...
[Read More]

* Please review the disclaimer below.

Hydrochlorothiazide Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine -7-sulfonamide 1,1-dioxide and has the following structural formula:Hydrochlorothiazide USP is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol, insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg and 50 mg hydrochlorothiazide. In addition, each tablet contains the following inactive ingredients: FD&C yellow #6, Microcrystalline cellulose, lactose anhydrous, Sodium starch glycolate, Stearic acid and Magnesium stearate.

Clinical Pharmacology

The mechanism of the antihypertensive effect of thiazides is unknown. Hydrochlorothiazide does not usually affect normal blood pressure. Hydrochlorothiazide affects the distal renal tubular mechanism of electrolyte reabsorption. At maximal therapeutic dosage all thiazides are approximately equal in their diuretic efficacy.Hydrochlorothiazide increases excretion of sodium and chloride in approximately equivalent amounts. Natriuresis may be accompanied by some loss of potassium and bicarbonate.After oral use diuresis begins within 2 hours, peaks in about 4 hours and lasts about 6 to12 hours.

Pharmacokinetics And Metabolism:

Hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidney. When plasma levels have been followed for at least 24 hours, the plasma half-life has been observed to vary between 5.6 and 14.8 hours. At least 61 % of the oral dose is eliminated unchanged within 24 hours. Hydrochlorothiazide crosses the placental but not the blood-brain barrier and is excreted in breast milk.

Indications And Usage

Hydrochlorothiazide tablets USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.Hydrochlorothiazide tablets USP have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.Hydrochlorothiazide tablets USP are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.Use in pregnancy:Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia.Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.

Contraindications

Anuria. Hypersensitivity to this product or to other sulfonamide-derived drugs.

Warnings

Use with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function. Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.Thiazides may add to or potentiate the action of other antihypertensive drugs.Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.Lithium generally should not be given with diuretics (see PRECAUTIONS, Drug Interactions).Acute Myopia and Secondary Angle-Closure GlaucomaHydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation., Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Adverse Reactions

The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity.

Overdosage

The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.In the event of overdosage, symptomatic and supportive measures should be employed. Emesis should be induced or gastric lavage performed. Correct dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures. If required, give oxygen or artificial respiration for respiratory impairment. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established.The oral LD50 of hydrochlorothiazide is greater than 10 g/kg in the mouse and rat.

Dosage And Administration

Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.

Adults

For Edema The usual adult dosage is 25 to 100 mg daily as a single or divided dose. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.For Control of HypertensionThe usual initial dose in adults is 25 mg daily given as a single dose. The dose may be increased to 50 mg daily, given as a single or two divided doses. Doses above 50 mg are often associated with marked reductions in serum potassium (see also PRECAUTIONS).Patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.

Infants And Children

For Diuresis and for Control of HypertensionThe usual pediatric dosage is 0.5 to 1 mg per pound (1 to 2 mg/kg) per day in single or two divided doses, not to exceed 37.5 mg per day in infants up to 2 years of age or 100 mg per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 1.5 mg per pound (3 mg/kg) per day in two divided doses may be required. (See PRECAUTIONS, Pediatric Use)

How Supplied

Hydrochlorothiazide Tablets USP 25 mg are available as peach color, round, flat face, beveled edge, bisected tablets, debossed "EP" above bisect and "131" below bisect on one side and plain on the other side containing 25 mg of hydrochlorothioazide USP, packaged in:100 TABLET in a BOTTLE (53217-232-00)14 TABLET in a BOTTLE, PLASTIC (53217-232-14)30 TABLET in a BOTTLE, PLASTIC (53217-232-30)60 TABLET in a BOTTLE (53217-232-60)90 TABLET in a BOTTLE (53217-232-90)Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

* Please review the disclaimer below.