oxybutynin chloride

Generic: oxybutynin chloride

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin chloride
Generic Name oxybutynin chloride
Labeler leading pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxybutynin chloride 5 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-182
Product ID 69315-182_da4b3e8b-09d1-4ef3-a24a-ef078f13bd92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212798
Listing Expiration 2026-12-31
Marketing Start 2019-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315182
Hyphenated Format 69315-182

Supplemental Identifiers

RxCUI
863664
UPC
0369315182017 0369315182109 0369315182055
UNII
L9F3D9RENQ

Packaging Origin

Original Packager
true

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 ANDA212798 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69315-182-01)
  • 500 TABLET in 1 BOTTLE (69315-182-05)
  • 1000 TABLET in 1 BOTTLE (69315-182-10)
source: ndc

Packages (3)

69315-182-01 100 TABLET in 1 BOTTLE (69315-182-01) 69315-182-05 500 TABLET in 1 BOTTLE (69315-182-05) 69315-182-10 1000 TABLET in 1 BOTTLE (69315-182-10)

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": "da4b3e8b-09d1-4ef3-a24a-ef078f13bd92", "openfda": {"upc": ["0369315182017", "0369315182109", "0369315182055"], "unii": ["L9F3D9RENQ"], "rxcui": ["863664"], "spl_set_id": ["b73b8338-8045-448f-87a6-3d289227d00e"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69315-182-01)", "package_ndc": "69315-182-01", "marketing_start_date": "20191101"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69315-182-05)", "package_ndc": "69315-182-05", "marketing_start_date": "20191101"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (69315-182-10)", "package_ndc": "69315-182-10", "marketing_start_date": "20191101"}], "brand_name": "OXYBUTYNIN CHLORIDE", "product_id": "69315-182_da4b3e8b-09d1-4ef3-a24a-ef078f13bd92", "dosage_form": "TABLET", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "69315-182", "generic_name": "OXYBUTYNIN CHLORIDE", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXYBUTYNIN CHLORIDE", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA212798", "marketing_category": "ANDA", "marketing_start_date": "20191101", "listing_expiration_date": "20261231"}