oxybutynin chloride

Generic: oxybutynin chloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin chloride
Generic Name oxybutynin chloride
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

oxybutynin chloride 5 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-520
Product ID 62135-520_2f102c1a-f5e5-43a2-e063-6294a90a0a91
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075039
Listing Expiration 2026-12-31
Marketing Start 1999-01-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135520
Hyphenated Format 62135-520

Supplemental Identifiers

RxCUI
863599
UPC
0362135520472
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 ANDA075039 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (62135-520-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-520-05)
  • 473 mL in 1 BOTTLE (62135-520-47)
source: ndc

Packages (2)

62135-520-24 2 TRAY in 1 BOX (62135-520-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-520-05) 62135-520-47 473 mL in 1 BOTTLE (62135-520-47)

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": "2f102c1a-f5e5-43a2-e063-6294a90a0a91", "openfda": {"upc": ["0362135520472"], "unii": ["L9F3D9RENQ"], "rxcui": ["863599"], "spl_set_id": ["d02e411b-2f34-4d08-a92a-9762cab47269"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (62135-520-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-520-05)", "package_ndc": "62135-520-24", "marketing_start_date": "20250226"}, {"sample": false, "description": "473 mL in 1 BOTTLE (62135-520-47)", "package_ndc": "62135-520-47", "marketing_start_date": "20221219"}], "brand_name": "Oxybutynin Chloride", "product_id": "62135-520_2f102c1a-f5e5-43a2-e063-6294a90a0a91", "dosage_form": "SOLUTION", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "62135-520", "generic_name": "Oxybutynin Chloride", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxybutynin Chloride", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA075039", "marketing_category": "ANDA", "marketing_start_date": "19990129", "listing_expiration_date": "20261231"}