oxybutynin chloride

Generic: oxybutynin chloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin chloride
Generic Name oxybutynin chloride
Labeler major pharmaceuticals
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

oxybutynin chloride 5 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6570
Product ID 0904-6570_4eb0d216-64dc-4192-88c1-39b134612e37
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204010
Listing Expiration 2026-12-31
Marketing Start 2015-11-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046570
Hyphenated Format 0904-6570

Supplemental Identifiers

RxCUI
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 (source: ndc)
Generic Name oxybutynin chloride (source: ndc)
Application Number ANDA204010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-6570-04) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 50 BLISTER PACK in 1 CARTON (0904-6570-06) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 100 BLISTER PACK in 1 CARTON (0904-6570-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

0904-6570-04 30 BLISTER PACK in 1 CARTON (0904-6570-04) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 0904-6570-06 50 BLISTER PACK in 1 CARTON (0904-6570-06) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 0904-6570-61 100 BLISTER PACK in 1 CARTON (0904-6570-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

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": "4eb0d216-64dc-4192-88c1-39b134612e37", "openfda": {"unii": ["L9F3D9RENQ"], "rxcui": ["863636"], "spl_set_id": ["7688cce8-797d-454c-95fb-52689741582e"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-6570-04)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-6570-04", "marketing_start_date": "20151102"}, {"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-6570-06)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-6570-06", "marketing_start_date": "20151102"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6570-61)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-6570-61", "marketing_start_date": "20151102"}], "brand_name": "Oxybutynin Chloride", "product_id": "0904-6570_4eb0d216-64dc-4192-88c1-39b134612e37", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0904-6570", "generic_name": "Oxybutynin Chloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxybutynin Chloride", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA204010", "marketing_category": "ANDA", "marketing_start_date": "20151102", "listing_expiration_date": "20261231"}