ursodiol

Generic: ursosiol

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

Drug Facts

Product Profile

Brand Name ursodiol
Generic Name ursosiol
Labeler pd-rx pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

ursadiol 300 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-871
Product ID 43063-871_3a2162b5-df74-1461-e063-6394a90a5e81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210707
Listing Expiration 2026-12-31
Marketing Start 2018-05-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063871
Hyphenated Format 43063-871

Supplemental Identifiers

RxCUI
858747
UPC
0343063871010
UNII
3D089V7L0K

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 ursodiol (source: ndc)
Generic Name ursosiol (source: ndc)
Application Number ANDA210707 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-01)
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-60)
  • 180 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-93)
source: ndc

Packages (3)

43063-871-01 100 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-01) 43063-871-60 60 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-60) 43063-871-93 180 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-93)

Ingredients (1)

ursadiol (300 mg/1)

Linked Drug Pages (1)

Ursodiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a2162b5-df74-1461-e063-6394a90a5e81", "openfda": {"upc": ["0343063871010"], "unii": ["3D089V7L0K"], "rxcui": ["858747"], "spl_set_id": ["d89c9e1e-a115-4a01-9275-74d6cd8cf285"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-01)", "package_ndc": "43063-871-01", "marketing_start_date": "20180726"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-60)", "package_ndc": "43063-871-60", "marketing_start_date": "20191210"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-93)", "package_ndc": "43063-871-93", "marketing_start_date": "20191210"}], "brand_name": "Ursodiol", "product_id": "43063-871_3a2162b5-df74-1461-e063-6394a90a5e81", "dosage_form": "CAPSULE", "product_ndc": "43063-871", "generic_name": "Ursosiol", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ursodiol", "active_ingredients": [{"name": "URSADIOL", "strength": "300 mg/1"}], "application_number": "ANDA210707", "marketing_category": "ANDA", "marketing_start_date": "20180517", "listing_expiration_date": "20261231"}