oxybutynin
oxybutynin is listed in the FDA National Drug Code directory with 9 NDC codes, marketed under brand name including oxybutynin. Available dosage form: tablet, film coated, extended release.
Drug Details
- Generic Name
- oxybutynin
- Brand Names
- oxybutynin
- Application Number
- ANDA202332
- Sponsor
- Zydus Pharmaceuticals USA Inc.
- NDC Codes
- 9
- Dosage Forms
- TABLET, FILM COATED, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- OXYBUTYNIN CHLORIDE
Indications and Usage
INDICATIONS & USAGE Oxybutynin chloride tablets, USP are 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).
Warnings
WARNINGS Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.