oxybutynin chloride

Generic: oxybutynin chloride

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin chloride
Generic Name oxybutynin chloride
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxybutynin chloride 5 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-005
Product ID 70954-005_db0e9137-4243-4f35-87fb-19668c1bd480
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209823
Listing Expiration 2026-12-31
Marketing Start 2017-11-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954005
Hyphenated Format 70954-005

Supplemental Identifiers

RxCUI
863664
UPC
0370954005308 0370954005100 0370954005209
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 ANDA209823 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70954-005-10)
  • 500 TABLET in 1 BOTTLE (70954-005-20)
  • 1000 TABLET in 1 BOTTLE (70954-005-30)
  • 100 BLISTER PACK in 1 CARTON (70954-005-50) / 1 TABLET in 1 BLISTER PACK (70954-005-40)
source: ndc

Packages (4)

70954-005-10 100 TABLET in 1 BOTTLE (70954-005-10) 70954-005-20 500 TABLET in 1 BOTTLE (70954-005-20) 70954-005-30 1000 TABLET in 1 BOTTLE (70954-005-30) 70954-005-50 100 BLISTER PACK in 1 CARTON (70954-005-50) / 1 TABLET in 1 BLISTER PACK (70954-005-40)

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": "db0e9137-4243-4f35-87fb-19668c1bd480", "openfda": {"upc": ["0370954005308", "0370954005100", "0370954005209"], "unii": ["L9F3D9RENQ"], "rxcui": ["863664"], "spl_set_id": ["3b1f5585-9b33-4a96-bf33-8e6bab14bf0c"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70954-005-10)", "package_ndc": "70954-005-10", "marketing_start_date": "20171115"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70954-005-20)", "package_ndc": "70954-005-20", "marketing_start_date": "20171115"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (70954-005-30)", "package_ndc": "70954-005-30", "marketing_start_date": "20171115"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (70954-005-50)  / 1 TABLET in 1 BLISTER PACK (70954-005-40)", "package_ndc": "70954-005-50", "marketing_start_date": "20210820"}], "brand_name": "Oxybutynin Chloride", "product_id": "70954-005_db0e9137-4243-4f35-87fb-19668c1bd480", "dosage_form": "TABLET", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "70954-005", "generic_name": "Oxybutynin Chloride", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxybutynin Chloride", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA209823", "marketing_category": "ANDA", "marketing_start_date": "20171115", "listing_expiration_date": "20261231"}