oxybutynin chloride

Generic: oxybutynin chloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxybutynin chloride
Generic Name oxybutynin chloride
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxybutynin chloride 5 mg/1

Manufacturer
RISING PHARMA HOLDINGS, INC.

Identifiers & Regulatory

Product NDC 64980-431
Product ID 64980-431_92fdb885-c818-4c39-909a-7f2f53840d90
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209025
Listing Expiration 2026-12-31
Marketing Start 2018-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980431
Hyphenated Format 64980-431

Supplemental Identifiers

RxCUI
863664 863758
UPC
0364980431507 0364980431019 0364980531016 0364980431101
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 ANDA209025 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (64980-431-01)
  • 1000 TABLET in 1 BOTTLE (64980-431-10)
  • 500 TABLET in 1 BOTTLE (64980-431-50)
source: ndc

Packages (3)

64980-431-01 100 TABLET in 1 BOTTLE (64980-431-01) 64980-431-10 1000 TABLET in 1 BOTTLE (64980-431-10) 64980-431-50 500 TABLET in 1 BOTTLE (64980-431-50)

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": "92fdb885-c818-4c39-909a-7f2f53840d90", "openfda": {"upc": ["0364980431507", "0364980431019", "0364980531016", "0364980431101"], "unii": ["L9F3D9RENQ"], "rxcui": ["863664", "863758"], "spl_set_id": ["f8ed80f2-6c3d-4d7f-b761-c2447973c1f9"], "manufacturer_name": ["RISING PHARMA HOLDINGS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (64980-431-01)", "package_ndc": "64980-431-01", "marketing_start_date": "20180201"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (64980-431-10)", "package_ndc": "64980-431-10", "marketing_start_date": "20180201"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (64980-431-50)", "package_ndc": "64980-431-50", "marketing_start_date": "20180201"}], "brand_name": "OXYBUTYNIN CHLORIDE", "product_id": "64980-431_92fdb885-c818-4c39-909a-7f2f53840d90", "dosage_form": "TABLET", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "64980-431", "generic_name": "OXYBUTYNIN CHLORIDE", "labeler_name": "RISING PHARMA HOLDINGS, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXYBUTYNIN CHLORIDE", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA209025", "marketing_category": "ANDA", "marketing_start_date": "20180201", "listing_expiration_date": "20261231"}