ursodiol

Generic: ursodiol

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ursodiol
Generic Name ursodiol
Labeler chartwell rx, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

ursodiol 300 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-430
Product ID 62135-430_06fd3682-9361-c825-e063-6394a90a4cb3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213555
Listing Expiration 2026-12-31
Marketing Start 2020-08-17

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 62135430
Hyphenated Format 62135-430

Supplemental Identifiers

RxCUI
858747
UPC
0362135430603
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 ANDA213555 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (62135-430-60)
source: ndc

Packages (1)

62135-430-60 60 CAPSULE in 1 BOTTLE (62135-430-60)

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": "06fd3682-9361-c825-e063-6394a90a4cb3", "openfda": {"nui": ["N0000175802", "M0002475"], "upc": ["0362135430603"], "unii": ["724L30Y2QR"], "rxcui": ["858747"], "spl_set_id": ["31ff3961-3ef1-4ec3-b742-beb4b96de795"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (62135-430-60)", "package_ndc": "62135-430-60", "marketing_start_date": "20230103"}], "brand_name": "Ursodiol", "product_id": "62135-430_06fd3682-9361-c825-e063-6394a90a4cb3", "dosage_form": "CAPSULE", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "62135-430", "generic_name": "Ursodiol", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ursodiol", "active_ingredients": [{"name": "URSODIOL", "strength": "300 mg/1"}], "application_number": "ANDA213555", "marketing_category": "ANDA", "marketing_start_date": "20200817", "listing_expiration_date": "20261231"}