Home NDC 51407-754-01 URSODIOL
Product NDC 51407-754
Requested package NDC 51407-754-01
11-digit product format 514070754
Labeler code 51407
Product ID 51407-754_0631dc59-4622-8f2d-e063-6294a90a1a7b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ursodiol
Dosage form CAPSULE
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA210344
Marketing category ANDA
Marketing start 2021-01-22
Marketing end 2027-12-31
Substance URSODIOL
Active strength 300 mg/1
Pharmacologic classes Bile Acid [EPC], Bile Acids and Salts [CS]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210344-001 URSODIOL URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 A210344-002 URSODIOL URSODIOL 150MG CAPSULE / ORAL 2026-01-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210344-001 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 2026-02-19 14:30 UTC 2026-02 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210344-002 URSODIOL 150MG CAPSULE / ORAL 2026-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210344-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-01-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210344-002 URSODIOL 150MG CAPSULE / ORAL 2026-01-16 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base URSODIOL Active Ingredients# Ingredient, Strength table Ingredient Strength URSODIOL 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 724L30Y2QR 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 51407-754-01 URSODIOL 100 in 1 BOTTLE CAPSULE 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51407-754 URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 Current NDC, 1 package rows 20230926_fb317988-a4e3-9c9a-e053-6294a90a5990.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 · 3 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 51407-754-01 51407075401 100 CAPSULE in 1 BOTTLE (51407-754-01) 100 capsule 2023-05-05 2027-12-31 No No Historical