Ursodiol

Generic: Ursodiol

Labeler: Eywa Pharma Inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name Ursodiol
Generic Name Ursodiol
Labeler Eywa Pharma Inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

URSODIOL 300 mg/1

Identifiers & Regulatory

Product NDC 71930-015
Product ID 71930-015_dd8b43b1-eb1c-4a56-8afe-3099d10b7351
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212452
Listing Expiration 2027-12-31
Marketing Start 2020-02-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71930015
Hyphenated Format 71930-015

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 (71930-015-12)
source: ndc

Packages (1)

71930-015-12 100 CAPSULE in 1 BOTTLE (71930-015-12)

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": "dd8b43b1-eb1c-4a56-8afe-3099d10b7351", "openfda": {"nui": ["N0000175802", "M0002475"], "upc": ["0371930015120"], "unii": ["724L30Y2QR"], "rxcui": ["858747"], "spl_set_id": ["c98d6217-b305-4615-9c70-7259d94ca205"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["Eywa Pharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (71930-015-12)", "package_ndc": "71930-015-12", "marketing_start_date": "20200205"}], "brand_name": "Ursodiol", "product_id": "71930-015_dd8b43b1-eb1c-4a56-8afe-3099d10b7351", "dosage_form": "CAPSULE", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "71930-015", "generic_name": "Ursodiol", "labeler_name": "Eywa Pharma 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"}