oxybutynin chloride

Generic: oxybutynin chloride

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin chloride
Generic Name oxybutynin chloride
Labeler upsher-smith laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxybutynin chloride 5 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-0038
Product ID 0832-0038_45af3420-b44f-39a1-e063-6394a90ad626
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074625
Marketing Start 2011-11-07
Marketing End 2028-12-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08320038
Hyphenated Format 0832-0038

Supplemental Identifiers

RxCUI
863664
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 ANDA074625 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0832-0038-00)
  • 100 BLISTER PACK in 1 CARTON (0832-0038-01) / 1 TABLET in 1 BLISTER PACK (0832-0038-89)
  • 1000 TABLET in 1 BOTTLE (0832-0038-10)
  • 500 TABLET in 1 BOTTLE (0832-0038-50)
source: ndc

Packages (4)

0832-0038-00 100 TABLET in 1 BOTTLE (0832-0038-00) 0832-0038-01 100 BLISTER PACK in 1 CARTON (0832-0038-01) / 1 TABLET in 1 BLISTER PACK (0832-0038-89) 0832-0038-10 1000 TABLET in 1 BOTTLE (0832-0038-10) 0832-0038-50 500 TABLET in 1 BOTTLE (0832-0038-50)

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": "45af3420-b44f-39a1-e063-6394a90ad626", "openfda": {"unii": ["L9F3D9RENQ"], "rxcui": ["863664"], "spl_set_id": ["3ee6835a-7a7d-49a9-8460-2f1dd270ead3"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0832-0038-00)", "package_ndc": "0832-0038-00", "marketing_end_date": "20280731", "marketing_start_date": "20111107"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0832-0038-01)  / 1 TABLET in 1 BLISTER PACK (0832-0038-89)", "package_ndc": "0832-0038-01", "marketing_end_date": "20260731", "marketing_start_date": "20180315"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (0832-0038-10)", "package_ndc": "0832-0038-10", "marketing_end_date": "20281231", "marketing_start_date": "20111107"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0832-0038-50)", "package_ndc": "0832-0038-50", "marketing_end_date": "20270430", "marketing_start_date": "20111107"}], "brand_name": "Oxybutynin Chloride", "product_id": "0832-0038_45af3420-b44f-39a1-e063-6394a90ad626", "dosage_form": "TABLET", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "0832-0038", "generic_name": "Oxybutynin Chloride", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxybutynin Chloride", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA074625", "marketing_category": "ANDA", "marketing_end_date": "20281231", "marketing_start_date": "20111107"}