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 CAPSULE
Routes
ORAL
Active Ingredients

ursodiol 300 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-100
Product ID 60687-100_37f083e8-2223-360b-e063-6294a90aa549
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079082
Listing Expiration 2026-12-31
Marketing Start 2015-05-12

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 60687100
Hyphenated Format 60687-100

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 ANDA079082 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-100-01) / 1 CAPSULE in 1 BLISTER PACK (60687-100-11)
source: ndc

Packages (1)

60687-100-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-100-01) / 1 CAPSULE in 1 BLISTER PACK (60687-100-11)

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": "37f083e8-2223-360b-e063-6294a90aa549", "openfda": {"nui": ["N0000175802", "M0002475"], "unii": ["724L30Y2QR"], "rxcui": ["858747"], "spl_set_id": ["9ae9412b-36d5-4634-8d5c-cc96110821c0"], "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": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-100-01)  / 1 CAPSULE in 1 BLISTER PACK (60687-100-11)", "package_ndc": "60687-100-01", "marketing_start_date": "20150512"}], "brand_name": "Ursodiol", "product_id": "60687-100_37f083e8-2223-360b-e063-6294a90aa549", "dosage_form": "CAPSULE", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "60687-100", "generic_name": "Ursodiol", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ursodiol", "active_ingredients": [{"name": "URSODIOL", "strength": "300 mg/1"}], "application_number": "ANDA079082", "marketing_category": "ANDA", "marketing_start_date": "20150512", "listing_expiration_date": "20261231"}