oxybutynin chloride

Generic: oxybutynin chloride

Labeler: accord healthcare, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin chloride
Generic Name oxybutynin chloride
Labeler accord healthcare, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

oxybutynin chloride 10 mg/1

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-318
Product ID 16729-318_461437aa-cf86-2475-e063-6294a90afe5b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207138
Listing Expiration 2026-12-31
Marketing Start 2016-12-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729318
Hyphenated Format 16729-318

Supplemental Identifiers

RxCUI
863619 863628 863636
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 ANDA207138 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-318-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-318-16)
source: ndc

Packages (2)

16729-318-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-318-01) 16729-318-16 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-318-16)

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": "461437aa-cf86-2475-e063-6294a90afe5b", "openfda": {"unii": ["L9F3D9RENQ"], "rxcui": ["863619", "863628", "863636"], "spl_set_id": ["61496a1e-17bf-4f45-a20c-5bb98fe545ee"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-318-01)", "package_ndc": "16729-318-01", "marketing_start_date": "20161220"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-318-16)", "package_ndc": "16729-318-16", "marketing_start_date": "20170417"}], "brand_name": "oxybutynin chloride", "product_id": "16729-318_461437aa-cf86-2475-e063-6294a90afe5b", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "16729-318", "generic_name": "oxybutynin chloride", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "oxybutynin chloride", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA207138", "marketing_category": "ANDA", "marketing_start_date": "20161220", "listing_expiration_date": "20261231"}