Home NDC 43063-871 Ursodiol
Product NDC 43063-871
11-digit product format 430630871
Labeler code 43063
Product ID 43063-871_3a2162b5-df74-1461-e063-6394a90a5e81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ursosiol
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA210707
Marketing category ANDA
Marketing start 2018-05-17
Substance URSADIOL
Active strength 300 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210707-001 URSODIOL URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210707-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A210707-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Ursodiol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength URSADIOL 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3D089V7L0K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858747 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43063-871-01 Ursodiol 100 in 1 BOTTLE, PLASTIC CAPSULE 100 14 43063-871-60 Ursodiol 60 in 1 BOTTLE, PLASTIC CAPSULE 60 14 43063-871-93 Ursodiol 180 in 1 BOTTLE, PLASTIC CAPSULE 180 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-871 URSODIOL (URSOSIOL) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 Current NDC, Legacy NDC, 3 package rows 20240820_d89c9e1e-a115-4a01-9275-74d6cd8cf285.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43063-871-01 43063087101 100 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-01) 100 capsule 2018-07-26 0000-00-00 No No Current 43063-871-60 43063087160 60 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-60) 60 capsule 2019-12-10 0000-00-00 No No Current 43063-871-93 43063087193 180 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-93) 180 capsule 2019-12-10 0000-00-00 No No Current