ursodiol

Generic: ursodiol

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ursodiol
Generic Name ursodiol
Labeler strides pharma science limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

ursodiol 300 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-844
Product ID 64380-844_46e8718f-fb37-4590-ad7e-7a55913fddf4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210344
Listing Expiration 2026-12-31
Marketing Start 2021-09-13

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 64380844
Hyphenated Format 64380-844

Supplemental Identifiers

RxCUI
858747
UPC
0364380844068
UNII
724L30Y2QR
NUI
N0000175802 M0002475

Packaging Origin

Original Packager
true

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 ANDA210344 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (64380-844-04)
  • 100 CAPSULE in 1 BOTTLE (64380-844-06)
  • 500 CAPSULE in 1 BOTTLE (64380-844-07)
source: ndc

Packages (3)

64380-844-04 30 CAPSULE in 1 BOTTLE (64380-844-04) 64380-844-06 100 CAPSULE in 1 BOTTLE (64380-844-06) 64380-844-07 500 CAPSULE in 1 BOTTLE (64380-844-07)

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": "46e8718f-fb37-4590-ad7e-7a55913fddf4", "openfda": {"nui": ["N0000175802", "M0002475"], "upc": ["0364380844068"], "unii": ["724L30Y2QR"], "rxcui": ["858747"], "spl_set_id": ["9a6c1928-2d52-4d9a-8e83-f71892a7e98d"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (64380-844-04)", "package_ndc": "64380-844-04", "marketing_start_date": "20210913"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (64380-844-06)", "package_ndc": "64380-844-06", "marketing_start_date": "20210913"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (64380-844-07)", "package_ndc": "64380-844-07", "marketing_start_date": "20210913"}], "brand_name": "URSODIOL", "product_id": "64380-844_46e8718f-fb37-4590-ad7e-7a55913fddf4", "dosage_form": "CAPSULE", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "64380-844", "generic_name": "ursodiol", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "URSODIOL", "active_ingredients": [{"name": "URSODIOL", "strength": "300 mg/1"}], "application_number": "ANDA210344", "marketing_category": "ANDA", "marketing_start_date": "20210913", "listing_expiration_date": "20261231"}