oxybutynin chloride extended release

Generic: oxybutynin chloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin chloride extended release
Generic Name oxybutynin chloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

oxybutynin chloride 5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-282
Product ID 43353-282_a9056bad-e15c-4be4-a63c-f51362e2f025
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 43353282
Hyphenated Format 43353-282

Supplemental Identifiers

RxCUI
863619 863628 863636
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
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-282-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-282-53)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-282-60)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-282-80)
source: ndc

Packages (4)

43353-282-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-282-30) 43353-282-53 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-282-53) 43353-282-60 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-282-60) 43353-282-80 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-282-80)

Ingredients (1)

oxybutynin chloride (5 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": "a9056bad-e15c-4be4-a63c-f51362e2f025", "openfda": {"unii": ["L9F3D9RENQ"], "rxcui": ["863619", "863628", "863636"], "spl_set_id": ["02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-282-30)", "package_ndc": "43353-282-30", "marketing_start_date": "20170302"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-282-53)", "package_ndc": "43353-282-53", "marketing_start_date": "20170302"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-282-60)", "package_ndc": "43353-282-60", "marketing_start_date": "20170302"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-282-80)", "package_ndc": "43353-282-80", "marketing_start_date": "20230531"}], "brand_name": "Oxybutynin Chloride Extended Release", "product_id": "43353-282_a9056bad-e15c-4be4-a63c-f51362e2f025", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "43353-282", "generic_name": "Oxybutynin Chloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxybutynin Chloride", "brand_name_suffix": "Extended Release", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA078503", "marketing_category": "ANDA", "marketing_start_date": "20160309", "listing_expiration_date": "20261231"}