oxybutynin chloride

Generic: oxybutynin chloride

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin chloride
Generic Name oxybutynin chloride
Labeler avkare
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxybutynin chloride 5 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-456
Product ID 42291-456_3418aa43-c59d-8e55-e063-6394a90ae7e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208165
Listing Expiration 2026-12-31
Marketing Start 2025-05-01

Pharmacologic Class

Classes
cholinergic muscarinic antagonist [epc] cholinergic muscarinic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291456
Hyphenated Format 42291-456

Supplemental Identifiers

RxCUI
863664
UNII
L9F3D9RENQ

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name oxybutynin chloride (source: ndc)
Generic Name oxybutynin chloride (source: ndc)
Application Number ANDA208165 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (42291-456-50)
source: ndc

Packages (1)

42291-456-50 500 TABLET in 1 BOTTLE (42291-456-50)

Ingredients (1)

oxybutynin chloride (5 mg/1)

Linked Drug Pages (1)

Oxybutynin Chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3418aa43-c59d-8e55-e063-6394a90ae7e1", "openfda": {"unii": ["L9F3D9RENQ"], "rxcui": ["863664"], "spl_set_id": ["3418ca19-feb0-9821-e063-6394a90ae819"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (42291-456-50)", "package_ndc": "42291-456-50", "marketing_start_date": "20250501"}], "brand_name": "Oxybutynin Chloride", "product_id": "42291-456_3418aa43-c59d-8e55-e063-6394a90ae7e1", "dosage_form": "TABLET", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "42291-456", "generic_name": "Oxybutynin Chloride", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxybutynin Chloride", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA208165", "marketing_category": "ANDA", "marketing_start_date": "20250501", "listing_expiration_date": "20261231"}