oxybutynin chloride

Generic: oxybutynin chloride

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin chloride
Generic Name oxybutynin chloride
Labeler lannett company, inc.
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

oxybutynin chloride 5 mg/5mL

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 54838-510
Product ID 54838-510_693f3eb4-b7f1-420a-b813-ecd8e326882d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074520
Listing Expiration 2026-12-31
Marketing Start 1996-03-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54838510
Hyphenated Format 54838-510

Supplemental Identifiers

RxCUI
863599
UPC
0354838510805
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 ANDA074520 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE, PLASTIC (54838-510-80)
source: ndc

Packages (1)

54838-510-80 473 mL in 1 BOTTLE, PLASTIC (54838-510-80)

Ingredients (1)

oxybutynin chloride (5 mg/5mL)

Linked Drug Pages (1)

Oxybutynin Chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "693f3eb4-b7f1-420a-b813-ecd8e326882d", "openfda": {"upc": ["0354838510805"], "unii": ["L9F3D9RENQ"], "rxcui": ["863599"], "spl_set_id": ["615f3d95-197c-4fec-b81f-c26449c93c3b"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (54838-510-80)", "package_ndc": "54838-510-80", "marketing_start_date": "19960329"}], "brand_name": "Oxybutynin Chloride", "product_id": "54838-510_693f3eb4-b7f1-420a-b813-ecd8e326882d", "dosage_form": "SYRUP", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "54838-510", "generic_name": "Oxybutynin Chloride", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxybutynin Chloride", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA074520", "marketing_category": "ANDA", "marketing_start_date": "19960329", "listing_expiration_date": "20261231"}