Home NDC 10702-237 Ursodiol
Product NDC 10702-237
11-digit product format 107020237
Labeler code 10702
Product ID 10702-237_351bd434-3965-1167-e063-6294a90a1530
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ursosiol
Dosage form CAPSULE
Route ORAL
Labeler KVK-Tech, 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 10702-237 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 10702-237 10702-237-01 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210707-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-05-17 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10702-237-01 Ursodiol 100 in 1 BOTTLE CAPSULE 100 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10702-237 URSODIOL (URSOSIOL) CAPSULE [KVK-TECH, INC.] 9 Current NDC, Legacy NDC, 1 package rows 20250515_fff2640b-b704-4303-acae-8647fce58a08.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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 10702-237-01 10702023701 100 CAPSULE in 1 BOTTLE (10702-237-01) 100 capsule 2018-05-17 0000-00-00 No No Current