Drug Catalog - Product Detail
NYSTATIN TABS. TB 500MU 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 53489-0400-01 | SUN PHARMACEUTICALS | 100 | 500000UNIT | TABLET |
PACKAGE FILES
Generic Name
NYSTATIN
Substance Name
NYSTATIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA062838
Description
DESCRIPTION Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Its structural formula: Nystatin tablets are provided for oral administration as coated tablets containing 500,000 units nystatin. Inactive ingredients: anhydrous lactose, carnauba wax, corn starch, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, and titanium dioxide. Chemical Structure
How Supplied
HOW SUPPLIED Nystatin tablets, USP 500,000 units, are round, brown, film coated, debossed MP 83. Available as follows: Bottles of 50 NDC 53489-400-02 Bottles of 100 NDC 53489-400-01 Bottles of 250 NDC 53489-400-03 Bottles of 500 NDC 53489-400-05 Bottles of 1000 NDC 53489-400-10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Indications & Usage
INDICATIONS AND USAGE Nystatin tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.
Dosage and Administration
DOSAGE AND ADMINISTRATION The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.