oxybutynin chloride

Generic: oxybutynin chloride

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

oxybutynin chloride 5 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-371
Product ID 65162-371_25b959bc-5b59-4c9c-b7a0-ae475a8e0290
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204010
Listing Expiration 2026-12-31
Marketing Start 2015-11-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162371
Hyphenated Format 65162-371

Supplemental Identifiers

RxCUI
863619 863628 863636
UPC
0365162371031 0365162372038 0365162373035
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 ANDA204010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-03)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-09)
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-10)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-50)
source: ndc

Packages (4)

65162-371-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-03) 65162-371-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-09) 65162-371-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-10) 65162-371-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-50)

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": "25b959bc-5b59-4c9c-b7a0-ae475a8e0290", "openfda": {"upc": ["0365162371031", "0365162372038", "0365162373035"], "unii": ["L9F3D9RENQ"], "rxcui": ["863619", "863628", "863636"], "spl_set_id": ["53924eba-1919-4203-9a1e-d57dfdd3b963"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-03)", "package_ndc": "65162-371-03", "marketing_start_date": "20151102"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-09)", "package_ndc": "65162-371-09", "marketing_start_date": "20151102"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-10)", "package_ndc": "65162-371-10", "marketing_start_date": "20151102"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-50)", "package_ndc": "65162-371-50", "marketing_start_date": "20151102"}], "brand_name": "Oxybutynin Chloride", "product_id": "65162-371_25b959bc-5b59-4c9c-b7a0-ae475a8e0290", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "65162-371", "generic_name": "Oxybutynin Chloride", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxybutynin Chloride", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA204010", "marketing_category": "ANDA", "marketing_start_date": "20151102", "listing_expiration_date": "20261231"}