ursodiol

Generic: ursodiol

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ursodiol
Generic Name ursodiol
Labeler strides pharma science limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ursodiol 500 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-919
Product ID 64380-919_a9f0b231-1cf0-4695-b76c-111dfbe23d39
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213504
Listing Expiration 2026-12-31
Marketing Start 2021-02-08

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 64380919
Hyphenated Format 64380-919

Supplemental Identifiers

RxCUI
858733 858751
UPC
0364380919063 0364380918066
UNII
724L30Y2QR
NUI
N0000175802 M0002475

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 ursodiol (source: ndc)
Generic Name ursodiol (source: ndc)
Application Number ANDA213504 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (64380-919-06)
source: ndc

Packages (1)

64380-919-06 100 TABLET in 1 BOTTLE (64380-919-06)

Ingredients (1)

ursodiol (500 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": "a9f0b231-1cf0-4695-b76c-111dfbe23d39", "openfda": {"nui": ["N0000175802", "M0002475"], "upc": ["0364380919063", "0364380918066"], "unii": ["724L30Y2QR"], "rxcui": ["858733", "858751"], "spl_set_id": ["9d666bbc-98c4-445f-a5a2-cad1bcccde4e"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (64380-919-06)", "package_ndc": "64380-919-06", "marketing_start_date": "20210208"}], "brand_name": "URSODIOL", "product_id": "64380-919_a9f0b231-1cf0-4695-b76c-111dfbe23d39", "dosage_form": "TABLET", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "64380-919", "generic_name": "ursodiol", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "URSODIOL", "active_ingredients": [{"name": "URSODIOL", "strength": "500 mg/1"}], "application_number": "ANDA213504", "marketing_category": "ANDA", "marketing_start_date": "20210208", "listing_expiration_date": "20261231"}