oxybutynin chloride

Generic: oxybutynin chloride

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin chloride
Generic Name oxybutynin chloride
Labeler coupler llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

oxybutynin chloride 15 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1600
Product ID 67046-1600_46b2b02c-85d8-8404-e063-6294a90a0eef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211655
Listing Expiration 2026-12-31
Marketing Start 2025-09-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461600
Hyphenated Format 67046-1600

Supplemental Identifiers

RxCUI
863628
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 ANDA211655 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1600-3)
source: ndc

Packages (1)

67046-1600-3 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1600-3)

Ingredients (1)

oxybutynin chloride (15 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": "46b2b02c-85d8-8404-e063-6294a90a0eef", "openfda": {"unii": ["L9F3D9RENQ"], "rxcui": ["863628"], "spl_set_id": ["3f7dc283-b168-8251-e063-6294a90a45a2"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1600-3)", "package_ndc": "67046-1600-3", "marketing_start_date": "20250923"}], "brand_name": "Oxybutynin Chloride", "product_id": "67046-1600_46b2b02c-85d8-8404-e063-6294a90a0eef", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "67046-1600", "generic_name": "Oxybutynin Chloride", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxybutynin Chloride", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "15 mg/1"}], "application_number": "ANDA211655", "marketing_category": "ANDA", "marketing_start_date": "20250923", "listing_expiration_date": "20261231"}