oxybutynin chloride extended release

Generic: oxybutynin chloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin chloride extended release
Generic Name oxybutynin chloride
Labeler rising pharma holdings, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

oxybutynin chloride 10 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-210
Product ID 64980-210_6393f9a1-b51b-4baa-81f3-bb02d5e7dbc3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206121
Listing Expiration 2026-12-31
Marketing Start 2016-09-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980210
Hyphenated Format 64980-210

Supplemental Identifiers

RxCUI
863619 863628 863636
UPC
0364980211017 0364980210010 0364980209014
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 extended release (source: ndc)
Generic Name oxybutynin chloride (source: ndc)
Application Number ANDA206121 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-210-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-210-05)
source: ndc

Packages (2)

64980-210-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-210-01) 64980-210-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-210-05)

Ingredients (1)

oxybutynin chloride (10 mg/1)

Linked Drug Pages (1)

Oxybutynin Chloride Extended Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6393f9a1-b51b-4baa-81f3-bb02d5e7dbc3", "openfda": {"upc": ["0364980211017", "0364980210010", "0364980209014"], "unii": ["L9F3D9RENQ"], "rxcui": ["863619", "863628", "863636"], "spl_set_id": ["ab431781-3183-4638-b656-f40a61f07940"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-210-01)", "package_ndc": "64980-210-01", "marketing_start_date": "20160927"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-210-05)", "package_ndc": "64980-210-05", "marketing_start_date": "20220329"}], "brand_name": "Oxybutynin Chloride Extended Release", "product_id": "64980-210_6393f9a1-b51b-4baa-81f3-bb02d5e7dbc3", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "64980-210", "generic_name": "Oxybutynin Chloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxybutynin Chloride", "brand_name_suffix": "Extended Release", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA206121", "marketing_category": "ANDA", "marketing_start_date": "20160927", "listing_expiration_date": "20261231"}