0591-3159

Generic: ursodiol

Labeler: actavis pharma, inc.
NDC Directory DRUG FOR FURTHER PROCESSING DRUG FOR FURTHER PROCESSING Active

Drug Facts

Product Profile

Brand Name
Generic Name ursodiol
Labeler actavis pharma, inc.
Dosage Form CAPSULE
Active Ingredients

ursodiol 300 mg/1

Identifiers & Regulatory

Product NDC 0591-3159
Product ID 0591-3159_aebc5409-22f4-4c97-8cb5-ae68801ba35e
Product Type DRUG FOR FURTHER PROCESSING
Marketing Category DRUG FOR FURTHER PROCESSING
Listing Expiration 2026-12-31
Marketing Start 1987-12-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05913159
Hyphenated Format 0591-3159

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: label)
Generic Name ursodiol (source: ndc)
Application Number NDA019594 (source: label)
Routes
oral
source: label

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 12000 CAPSULE in 1 BOX (0591-3159-00)
  • 11210 CAPSULE in 1 CONTAINER (0591-3159-77)
source: ndc

Packages (2)

0591-3159-00 12000 CAPSULE in 1 BOX (0591-3159-00) 0591-3159-77 11210 CAPSULE in 1 CONTAINER (0591-3159-77)

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 
{"spl_id": "aebc5409-22f4-4c97-8cb5-ae68801ba35e", "openfda": {}, "finished": false, "packaging": [{"description": "12000 CAPSULE in 1 BOX (0591-3159-00)", "package_ndc": "0591-3159-00", "marketing_start_date": "31-DEC-87"}, {"description": "11210 CAPSULE in 1 CONTAINER (0591-3159-77)", "package_ndc": "0591-3159-77", "marketing_start_date": "01-SEP-24"}], "product_id": "0591-3159_aebc5409-22f4-4c97-8cb5-ae68801ba35e", "dosage_form": "CAPSULE", "product_ndc": "0591-3159", "generic_name": "Ursodiol", "labeler_name": "Actavis Pharma, Inc.", "product_type": "DRUG FOR FURTHER PROCESSING", "brand_name_base": null, "active_ingredients": [{"name": "URSODIOL", "strength": "300 mg/1"}], "marketing_category": "DRUG FOR FURTHER PROCESSING", "marketing_start_date": "19871231", "listing_expiration_date": "20261231"}