oxybutynin chloride

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
Generic Name oxybutynin chloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxybutynin chloride 5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-860
Product ID 71610-860_2425de26-9d88-2a5d-e063-6294a90acaa1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075079
Listing Expiration 2026-12-31
Marketing Start 2022-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610860
Hyphenated Format 71610-860

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 ANDA075079 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-860-30)
  • 60 TABLET in 1 BOTTLE (71610-860-53)
  • 90 TABLET in 1 BOTTLE (71610-860-60)
  • 180 TABLET in 1 BOTTLE (71610-860-80)
source: ndc

Packages (4)

71610-860-30 30 TABLET in 1 BOTTLE (71610-860-30) 71610-860-53 60 TABLET in 1 BOTTLE (71610-860-53) 71610-860-60 90 TABLET in 1 BOTTLE (71610-860-60) 71610-860-80 180 TABLET in 1 BOTTLE (71610-860-80)

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": "2425de26-9d88-2a5d-e063-6294a90acaa1", "openfda": {"unii": ["L9F3D9RENQ"], "rxcui": ["863664"], "spl_set_id": ["2425f49f-ade3-5178-e063-6294a90adfac"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-860-30)", "package_ndc": "71610-860-30", "marketing_start_date": "20241010"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-860-53)", "package_ndc": "71610-860-53", "marketing_start_date": "20241010"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-860-60)", "package_ndc": "71610-860-60", "marketing_start_date": "20241010"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-860-80)", "package_ndc": "71610-860-80", "marketing_start_date": "20241010"}], "brand_name": "Oxybutynin Chloride", "product_id": "71610-860_2425de26-9d88-2a5d-e063-6294a90acaa1", "dosage_form": "TABLET", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "71610-860", "generic_name": "oxybutynin chloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxybutynin Chloride", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA075079", "marketing_category": "ANDA", "marketing_start_date": "20220930", "listing_expiration_date": "20261231"}