oxybutynin

Generic: oxybutynin

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin
Generic Name oxybutynin
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

oxybutynin chloride 5 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-255
Product ID 68382-255_f54e4d4e-91be-4e10-a446-57ed5e1843a1
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 68382255
Hyphenated Format 68382-255

Supplemental Identifiers

RxCUI
863619 863628 863636
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 (68382-255-01)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-05)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-06)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-14)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-16)
  • 10 BLISTER PACK in 1 CARTON (68382-255-77) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-255-30)
source: ndc

Packages (6)

68382-255-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-01) 68382-255-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-05) 68382-255-06 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-06) 68382-255-14 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-14) 68382-255-16 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-16) 68382-255-77 10 BLISTER PACK in 1 CARTON (68382-255-77) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-255-30)

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": "f54e4d4e-91be-4e10-a446-57ed5e1843a1", "openfda": {"unii": ["L9F3D9RENQ"], "rxcui": ["863619", "863628", "863636"], "spl_set_id": ["c042bf06-79a3-4dc7-ae05-3ef3cfae9d44"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-01)", "package_ndc": "68382-255-01", "marketing_start_date": "20170810"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-05)", "package_ndc": "68382-255-05", "marketing_start_date": "20170810"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-06)", "package_ndc": "68382-255-06", "marketing_start_date": "20170810"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-14)", "package_ndc": "68382-255-14", "marketing_start_date": "20170810"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-16)", "package_ndc": "68382-255-16", "marketing_start_date": "20170810"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-255-77)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-255-30)", "package_ndc": "68382-255-77", "marketing_start_date": "20170810"}], "brand_name": "oxybutynin", "product_id": "68382-255_f54e4d4e-91be-4e10-a446-57ed5e1843a1", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "68382-255", "generic_name": "oxybutynin", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "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"}