oxybutynin chloride

Generic: oxybutynin chloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin chloride
Generic Name oxybutynin chloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxybutynin chloride 5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-978
Product ID 43353-978_c8f0373d-45aa-49dc-8436-4fc1a9304a57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074625
Listing Expiration 2026-12-31
Marketing Start 2011-11-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43353978
Hyphenated Format 43353-978

Supplemental Identifiers

RxCUI
863664
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 (source: ndc)
Generic Name oxybutynin chloride (source: ndc)
Application Number ANDA074625 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 270 TABLET in 1 BOTTLE (43353-978-92)
source: ndc

Packages (1)

43353-978-92 270 TABLET in 1 BOTTLE (43353-978-92)

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": "c8f0373d-45aa-49dc-8436-4fc1a9304a57", "openfda": {"unii": ["L9F3D9RENQ"], "rxcui": ["863664"], "spl_set_id": ["58136f28-70c1-4cf2-bcd7-858c5609431a"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "270 TABLET in 1 BOTTLE (43353-978-92)", "package_ndc": "43353-978-92", "marketing_start_date": "20141101"}], "brand_name": "Oxybutynin Chloride", "product_id": "43353-978_c8f0373d-45aa-49dc-8436-4fc1a9304a57", "dosage_form": "TABLET", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "43353-978", "generic_name": "Oxybutynin Chloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxybutynin Chloride", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA074625", "marketing_category": "ANDA", "marketing_start_date": "20111107", "listing_expiration_date": "20261231"}