oxybutynin chloride extended release

Generic: oxybutynin chloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin chloride extended release
Generic Name oxybutynin chloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

oxybutynin chloride 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-790
Product ID 43063-790_419e3f00-a475-03d5-e063-6394a90a5f89
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 43063790
Hyphenated Format 43063-790

Supplemental Identifiers

RxCUI
863619
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 chloride extended release (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, PLASTIC (43063-790-90)
source: ndc

Packages (1)

43063-790-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-790-90)

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": "419e3f00-a475-03d5-e063-6394a90a5f89", "openfda": {"unii": ["L9F3D9RENQ"], "rxcui": ["863619"], "spl_set_id": ["b5653b7e-1e3b-4da3-b3a2-33318f448c67"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-790-90)", "package_ndc": "43063-790-90", "marketing_start_date": "20170921"}], "brand_name": "Oxybutynin Chloride Extended Release", "product_id": "43063-790_419e3f00-a475-03d5-e063-6394a90a5f89", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "43063-790", "generic_name": "Oxybutynin Chloride", "labeler_name": "PD-Rx Pharmaceuticals, 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": "ANDA078503", "marketing_category": "ANDA", "marketing_start_date": "20090301", "listing_expiration_date": "20261231"}