oxybutynin chloride

Generic: oxybutynin chloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

oxybutynin chloride 5 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-851
Product ID 43063-851_2fc3d8ae-3605-f8df-e063-6294a90ab12f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209335
Listing Expiration 2026-12-31
Marketing Start 2017-12-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063851
Hyphenated Format 43063-851

Supplemental Identifiers

RxCUI
863664
UPC
0343063851906
UNII
L9F3D9RENQ

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 ANDA209335 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (43063-851-01)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-851-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (43063-851-90)
source: ndc

Packages (3)

43063-851-01 100 TABLET in 1 BOTTLE, PLASTIC (43063-851-01) 43063-851-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-851-60) 43063-851-90 90 TABLET in 1 BOTTLE, PLASTIC (43063-851-90)

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": "2fc3d8ae-3605-f8df-e063-6294a90ab12f", "openfda": {"upc": ["0343063851906"], "unii": ["L9F3D9RENQ"], "rxcui": ["863664"], "spl_set_id": ["0c021aad-97a3-4404-a11e-cdd2ec731c6b"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (43063-851-01)", "package_ndc": "43063-851-01", "marketing_start_date": "20190321"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-851-60)", "package_ndc": "43063-851-60", "marketing_start_date": "20180611"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (43063-851-90)", "package_ndc": "43063-851-90", "marketing_start_date": "20180611"}], "brand_name": "Oxybutynin Chloride", "product_id": "43063-851_2fc3d8ae-3605-f8df-e063-6294a90ab12f", "dosage_form": "TABLET", "pharm_class": ["Cholinergic Muscarinic Antagonist [EPC]", "Cholinergic Muscarinic Antagonists [MoA]"], "product_ndc": "43063-851", "generic_name": "Oxybutynin Chloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxybutynin Chloride", "active_ingredients": [{"name": "OXYBUTYNIN CHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA209335", "marketing_category": "ANDA", "marketing_start_date": "20171222", "listing_expiration_date": "20261231"}