Package 42385-946-01

Brand: ursodiol

Generic: ursodiol
NDC Package

Package Facts

Identity

Package NDC 42385-946-01
Digits Only 4238594601
Product NDC 42385-946
Description

100 CAPSULE in 1 BOTTLE (42385-946-01)

Marketing

Marketing Status
Marketed Since 2021-04-17
Brand ursodiol
Generic ursodiol
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "1e5a692a-cb69-4f27-b330-f4ab3cf363c7", "openfda": {"nui": ["N0000175802", "M0002475"], "unii": ["724L30Y2QR"], "rxcui": ["858747"], "spl_set_id": ["6be8e383-37fa-4e0a-b9fc-3976a8be1d2f"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["Laurus Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (42385-946-01)", "package_ndc": "42385-946-01", "marketing_start_date": "20210417"}], "brand_name": "Ursodiol", "product_id": "42385-946_1e5a692a-cb69-4f27-b330-f4ab3cf363c7", "dosage_form": "CAPSULE", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "42385-946", "generic_name": "Ursodiol", "labeler_name": "Laurus Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ursodiol", "active_ingredients": [{"name": "URSODIOL", "strength": "300 mg/1"}], "application_number": "ANDA213200", "marketing_category": "ANDA", "marketing_start_date": "20210417", "listing_expiration_date": "20261231"}