oxybutynin chloride

Generic: oxybutynin chloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

oxybutynin chloride 10 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-508
Product ID 62135-508_4687ad2c-dc3d-4a95-e063-6394a90a8dfd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078503
Listing Expiration 2026-12-31
Marketing Start 2009-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135508
Hyphenated Format 62135-508

Supplemental Identifiers

RxCUI
863619 863628 863636
UPC
0362135508906 0362135509903 0362135507909
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 ANDA078503 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-508-90)
source: ndc

Packages (1)

62135-508-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-508-90)

Ingredients (1)

oxybutynin chloride (10 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": "4687ad2c-dc3d-4a95-e063-6394a90a8dfd", "openfda": {"upc": ["0362135508906", "0362135509903", "0362135507909"], "unii": ["L9F3D9RENQ"], "rxcui": ["863619", "863628", "863636"], "spl_set_id": ["e464c8dd-5222-4a6b-b7e9-ca608a403c6e"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-508-90)", "package_ndc": "62135-508-90", "marketing_start_date": "20230303"}], "brand_name": "oxybutynin chloride", "product_id": "62135-508_4687ad2c-dc3d-4a95-e063-6394a90a8dfd", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "62135-508", "generic_name": "OXYBUTYNIN CHLORIDE", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "oxybutynin chloride", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078503", "marketing_category": "ANDA", "marketing_start_date": "20090301", "listing_expiration_date": "20261231"}