ursodiol

Generic: ursodiol

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ursodiol
Generic Name ursodiol
Labeler major pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

ursodiol 300 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6221
Product ID 0904-6221_7aace946-7c2a-422f-a905-c6afe5f8327f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075517
Listing Expiration 2026-12-31
Marketing Start 2011-04-01

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 09046221
Hyphenated Format 0904-6221

Supplemental Identifiers

RxCUI
858747
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 ANDA075517 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 CARTON (0904-6221-06) / 1 CAPSULE in 1 BLISTER PACK
  • 100 BLISTER PACK in 1 CARTON (0904-6221-61) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (2)

0904-6221-06 50 BLISTER PACK in 1 CARTON (0904-6221-06) / 1 CAPSULE in 1 BLISTER PACK 0904-6221-61 100 BLISTER PACK in 1 CARTON (0904-6221-61) / 1 CAPSULE in 1 BLISTER PACK

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": "7aace946-7c2a-422f-a905-c6afe5f8327f", "openfda": {"nui": ["N0000175802", "M0002475"], "unii": ["724L30Y2QR"], "rxcui": ["858747"], "spl_set_id": ["c9aa0223-3ea4-4cb7-b53b-f35e5a04cec7"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-6221-06)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-6221-06", "marketing_start_date": "20110401"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6221-61)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-6221-61", "marketing_start_date": "20110401"}], "brand_name": "Ursodiol", "product_id": "0904-6221_7aace946-7c2a-422f-a905-c6afe5f8327f", "dosage_form": "CAPSULE", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "0904-6221", "generic_name": "Ursodiol", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ursodiol", "active_ingredients": [{"name": "URSODIOL", "strength": "300 mg/1"}], "application_number": "ANDA075517", "marketing_category": "ANDA", "marketing_start_date": "20110401", "listing_expiration_date": "20261231"}