oxybutynin chloride extended release

Generic: oxybutynin chloride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin chloride extended release
Generic Name oxybutynin chloride
Labeler american health packaging
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

oxybutynin chloride 5 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-480
Product ID 68084-480_230831a1-53bb-f16b-e063-6394a90ab9df
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078503
Listing Expiration 2026-12-31
Marketing Start 2012-01-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084480
Hyphenated Format 68084-480

Supplemental Identifiers

RxCUI
863619 863636
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
  • 5 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-480-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-480-11)
  • 50 BLISTER PACK in 1 CARTON (68084-480-65) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-480-11)
source: ndc

Packages (2)

68084-480-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-480-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-480-11) 68084-480-65 50 BLISTER PACK in 1 CARTON (68084-480-65) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-480-11)

Ingredients (1)

oxybutynin chloride (5 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": "230831a1-53bb-f16b-e063-6394a90ab9df", "openfda": {"unii": ["L9F3D9RENQ"], "rxcui": ["863619", "863636"], "spl_set_id": ["0c71bdfb-01db-49ac-a8e9-0037df0d24af"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-480-01)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-480-11)", "package_ndc": "68084-480-01", "marketing_start_date": "20120113"}, {"sample": false, "description": "50 BLISTER PACK in 1 CARTON (68084-480-65)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-480-11)", "package_ndc": "68084-480-65", "marketing_start_date": "20230221"}], "brand_name": "Oxybutynin Chloride Extended Release", "product_id": "68084-480_230831a1-53bb-f16b-e063-6394a90ab9df", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "68084-480", "generic_name": "Oxybutynin Chloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxybutynin Chloride", "brand_name_suffix": "Extended Release", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA078503", "marketing_category": "ANDA", "marketing_start_date": "20120113", "listing_expiration_date": "20261231"}