oxybutynin

Generic: oxybutynin

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin
Generic Name oxybutynin
Labeler zydus lifesciences limited
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

oxybutynin chloride 5 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1086
Product ID 70771-1086_e2d9aa83-078e-4c67-a9d0-8c166bc4d9f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202332
Listing Expiration 2026-12-31
Marketing Start 2017-08-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711086
Hyphenated Format 70771-1086

Supplemental Identifiers

RxCUI
863619 863628 863636
UPC
0368382256010
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 (source: ndc)
Generic Name oxybutynin (source: ndc)
Application Number ANDA202332 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-1)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-3)
  • 10 BLISTER PACK in 1 CARTON (70771-1086-4) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70771-1086-2)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-5)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-6)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-9)
source: ndc

Packages (6)

70771-1086-1 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-1) 70771-1086-3 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-3) 70771-1086-4 10 BLISTER PACK in 1 CARTON (70771-1086-4) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70771-1086-2) 70771-1086-5 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-5) 70771-1086-6 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-6) 70771-1086-9 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-9)

Ingredients (1)

oxybutynin chloride (5 mg/1)

Linked Drug Pages (1)

oxybutynin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e2d9aa83-078e-4c67-a9d0-8c166bc4d9f0", "openfda": {"upc": ["0368382256010"], "unii": ["L9F3D9RENQ"], "rxcui": ["863619", "863628", "863636"], "spl_set_id": ["f405a774-bd91-4513-b7c7-c44f0596d988"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-1)", "package_ndc": "70771-1086-1", "marketing_start_date": "20170810"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-3)", "package_ndc": "70771-1086-3", "marketing_start_date": "20170810"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1086-4)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70771-1086-2)", "package_ndc": "70771-1086-4", "marketing_start_date": "20170810"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-5)", "package_ndc": "70771-1086-5", "marketing_start_date": "20170810"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-6)", "package_ndc": "70771-1086-6", "marketing_start_date": "20170810"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-9)", "package_ndc": "70771-1086-9", "marketing_start_date": "20170810"}], "brand_name": "oxybutynin", "product_id": "70771-1086_e2d9aa83-078e-4c67-a9d0-8c166bc4d9f0", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "70771-1086", "generic_name": "oxybutynin", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "oxybutynin", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA202332", "marketing_category": "ANDA", "marketing_start_date": "20170810", "listing_expiration_date": "20261231"}