ursodiol

Generic: ursosiol

Labeler: kvk-tech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ursodiol
Generic Name ursosiol
Labeler kvk-tech, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

ursadiol 300 mg/1

Manufacturer
KVK-Tech, Inc.

Identifiers & Regulatory

Product NDC 10702-237
Product ID 10702-237_351bd434-3965-1167-e063-6294a90a1530
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 10702237
Hyphenated Format 10702-237

Supplemental Identifiers

RxCUI
858747
UNII
3D089V7L0K

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 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 (10702-237-01)
source: ndc

Packages (1)

10702-237-01 100 CAPSULE in 1 BOTTLE (10702-237-01)

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": "351bd434-3965-1167-e063-6294a90a1530", "openfda": {"unii": ["3D089V7L0K"], "rxcui": ["858747"], "spl_set_id": ["fff2640b-b704-4303-acae-8647fce58a08"], "manufacturer_name": ["KVK-Tech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (10702-237-01)", "package_ndc": "10702-237-01", "marketing_start_date": "20180517"}], "brand_name": "Ursodiol", "product_id": "10702-237_351bd434-3965-1167-e063-6294a90a1530", "dosage_form": "CAPSULE", "product_ndc": "10702-237", "generic_name": "Ursosiol", "labeler_name": "KVK-Tech, 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"}