oxybutynin

Generic: oxybutynin

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin
Generic Name oxybutynin
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

oxybutynin chloride 5 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8219
Product ID 0615-8219_7a51ea21-3f85-4693-8e7e-ed031f257496
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202332
Listing Expiration 2026-12-31
Marketing Start 2017-08-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158219
Hyphenated Format 0615-8219

Supplemental Identifiers

RxCUI
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 (source: ndc)
Generic Name oxybutynin (source: ndc)
Application Number ANDA202332 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-8219-39)
source: ndc

Packages (1)

0615-8219-39 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-8219-39)

Ingredients (1)

oxybutynin chloride (5 mg/1)

Linked Drug Pages (1)

oxybutynin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7a51ea21-3f85-4693-8e7e-ed031f257496", "openfda": {"unii": ["L9F3D9RENQ"], "rxcui": ["863636"], "spl_set_id": ["ed10f0c9-23d6-4ded-b17f-ed474632a965"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-8219-39)", "package_ndc": "0615-8219-39", "marketing_start_date": "20190125"}], "brand_name": "oxybutynin", "product_id": "0615-8219_7a51ea21-3f85-4693-8e7e-ed031f257496", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0615-8219", "generic_name": "oxybutynin", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "oxybutynin", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA202332", "marketing_category": "ANDA", "marketing_start_date": "20170810", "listing_expiration_date": "20261231"}