ursodiol

Generic: ursodiol

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ursodiol
Generic Name ursodiol
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ursodiol 250 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-527
Product ID 60687-527_437ecc8a-2e45-94a1-e063-6394a90acc85
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211145
Listing Expiration 2026-12-31
Marketing Start 2020-09-11

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 60687527
Hyphenated Format 60687-527

Supplemental Identifiers

RxCUI
858751
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 ANDA211145 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-527-21) / 1 TABLET in 1 BLISTER PACK (60687-527-11)
source: ndc

Packages (1)

60687-527-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-527-21) / 1 TABLET in 1 BLISTER PACK (60687-527-11)

Ingredients (1)

ursodiol (250 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": "437ecc8a-2e45-94a1-e063-6394a90acc85", "openfda": {"nui": ["N0000175802", "M0002475"], "unii": ["724L30Y2QR"], "rxcui": ["858751"], "spl_set_id": ["a3a90d07-0dac-48fc-829a-759d9333843e"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-527-21)  / 1 TABLET in 1 BLISTER PACK (60687-527-11)", "package_ndc": "60687-527-21", "marketing_start_date": "20200911"}], "brand_name": "Ursodiol", "product_id": "60687-527_437ecc8a-2e45-94a1-e063-6394a90acc85", "dosage_form": "TABLET", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "60687-527", "generic_name": "Ursodiol", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ursodiol", "active_ingredients": [{"name": "URSODIOL", "strength": "250 mg/1"}], "application_number": "ANDA211145", "marketing_category": "ANDA", "marketing_start_date": "20200911", "listing_expiration_date": "20261231"}