oxybutynin chloride extended release (42291-634)

Drug Facts

Product Profile

Brand Name oxybutynin chloride extended release

Generic Name oxybutynin chloride

Labeler avkare

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

oxybutynin chloride 10 mg/1

Manufacturer

AvKARE

Identifiers & Regulatory

Product NDC 42291-634

Product ID 42291-634_46143c62-4276-2b49-e063-6294a90ae1aa

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078503

Listing Expiration 2026-12-31

Marketing Start 2016-03-09

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291634

Hyphenated Format 42291-634

Supplemental Identifiers

RxCUI

863619 863628 863636

UPC

0342291635012 0342291633018 0342291634503 0342291633506

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 extended release (source: ndc)

Generic Name oxybutynin chloride (source: ndc)

Application Number ANDA078503 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1

source: ndc

Packaging

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-634-01)
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-634-50)

source: ndc

Packages (2)

42291-634-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-634-01) 42291-634-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-634-50)

Ingredients (1)

oxybutynin chloride (10 mg/1)

Linked Drug Pages (1)

Oxybutynin Chloride Extended Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "46143c62-4276-2b49-e063-6294a90ae1aa", "openfda": {"upc": ["0342291635012", "0342291633018", "0342291634503", "0342291633506"], "unii": ["L9F3D9RENQ"], "rxcui": ["863619", "863628", "863636"], "spl_set_id": ["94471401-a516-0fe7-ec9c-447dd2bee972"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-634-01)", "package_ndc": "42291-634-01", "marketing_start_date": "20160309"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-634-50)", "package_ndc": "42291-634-50", "marketing_start_date": "20160309"}], "brand_name": "Oxybutynin Chloride Extended Release", "product_id": "42291-634_46143c62-4276-2b49-e063-6294a90ae1aa", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "42291-634", "generic_name": "Oxybutynin Chloride", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxybutynin Chloride", "brand_name_suffix": "Extended Release", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078503", "marketing_category": "ANDA", "marketing_start_date": "20160309", "listing_expiration_date": "20261231"}