ursodiol

Generic: ursodiol

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

Drug Facts

Product Profile

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

ursodiol 300 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-205
Product ID 72789-205_4b085f84-2f38-4127-e063-6394a90a1ece
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212452
Listing Expiration 2027-12-31
Marketing Start 2020-02-05

Pharmacologic Class

Established (EPC)
bile acid [epc]
Chemical Structure
bile acids and salts [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789205
Hyphenated Format 72789-205

Supplemental Identifiers

RxCUI
858747
UPC
0372789205014
UNII
724L30Y2QR
NUI
N0000175802 M0002475

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 ursodiol (source: ndc)
Application Number ANDA212452 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (72789-205-01)
source: ndc

Packages (1)

72789-205-01 100 CAPSULE in 1 BOTTLE, PLASTIC (72789-205-01)

Ingredients (1)

ursodiol (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": "4b085f84-2f38-4127-e063-6394a90a1ece", "openfda": {"nui": ["N0000175802", "M0002475"], "upc": ["0372789205014"], "unii": ["724L30Y2QR"], "rxcui": ["858747"], "spl_set_id": ["1276283e-21b0-4932-864f-547c62bd49e5"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (72789-205-01)", "package_ndc": "72789-205-01", "marketing_start_date": "20211011"}], "brand_name": "Ursodiol", "product_id": "72789-205_4b085f84-2f38-4127-e063-6394a90a1ece", "dosage_form": "CAPSULE", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "72789-205", "generic_name": "Ursodiol", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ursodiol", "active_ingredients": [{"name": "URSODIOL", "strength": "300 mg/1"}], "application_number": "ANDA212452", "marketing_category": "ANDA", "marketing_start_date": "20200205", "listing_expiration_date": "20271231"}