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Drug Catalog - Product Detail

OXYBUTYNIN CHLORIDE 5MG TB 1000

NDC Mfr Size Str Form
10702-0201-10 KVK TECH 1000 5MG TABLET
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PACKAGE FILES

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Generic Name
OXYBUTYNIN CHLORIDE
Substance Name
OXYBUTYNIN CHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA209335
Description
DESCRIPTION Each scored biconvex, very light to light blue Oxybutynin Chloride Tablet, USP contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C 22 H 31 NO 3 •HCl. The structural formula appears below: Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin Chloride Tablets, USP also contain FD&C Blue # 1/Brilliant Blue FCF aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Oxybutynin Chloride Tablets, USP are for oral administration. Therapeutic Category: Antispasmodic, anticholinergic. USP Dissolution Test 2 used. Structural Formula
How Supplied
HOW SUPPLIED Oxybutynin Chloride Tablets USP, 5 mg, are very light to light blue, round biconvex tablets, debossed with “A” and “44”, separated by a horizontal score on one side and plain on the other side. The tablets are supplied as follows: Bottles of 100: NDC 10702-201-01 Bottles of 500: NDC 10702-201-50 Bottles of 1000: NDC 10702-201-10 Pharmacist: Dispense in a tight, light-resistant container as defined in the USP. Store at 20°C to 25°C (68°F to 77°F); excursions permitted within 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Indications & Usage
INDICATIONS AND USAGE Oxybutynin chloride is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).
Dosage and Administration
DOSAGE AND ADMINISTRATION Adults The usual dose is one 5-mg tablet two to three times a day. The maximum recommended dose is one 5-mg tablet four times a day. A lower starting dose of 2.5 mg two or three times a day is recommended for the frail elderly. Pediatric patients over 5 years of age The usual dose is one 5-mg tablet two times a day. The maximum recommended dose is one 5-mg tablet three times a day.