Home NDC 50268-797 Ursodiol
Product NDC 50268-797
11-digit product format 502680797
Labeler code 50268
Product ID 50268-797_48378beb-66aa-975e-e063-6294a90a0aee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ursodiol
Dosage form CAPSULE
Route ORAL
Labeler AvPAK
Application ANDA211301
Marketing category ANDA
Marketing start 2021-02-19
Substance URSODIOL
Active strength 300 mg/1
Pharmacologic classes Bile Acid [EPC], Bile Acids and Salts [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A211301-001 URSODIOL URSODIOL 300MG CAPSULE / ORAL 2018-10-16
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 A211301-001 URSODIOL 300MG CAPSULE / ORAL 2018-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211301-001 URSODIOL 300MG CAPSULE / ORAL 2018-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211301-001 URSODIOL 300MG CAPSULE / ORAL AB 2018-10-16 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ursodiol
Listing expiration 2027-12-31 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 50268-797-11 Ursodiol 1 in 1 BLISTER PACK CAPSULE 1 4 50268-797-15 Ursodiol 50 in 1 BOX CAPSULE 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-797 URSODIOL CAPSULE [AVPAK] 3 Current NDC, Legacy NDC, 2 package rows 20240110_bbb1f297-1536-9550-e053-2995a90a0d41.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 50268-797-11 50268079711 1 in 1 BLISTER PACK Historical 50268-797-15 50268079715 50 BLISTER PACK in 1 BOX (50268-797-15) / 1 CAPSULE in 1 BLISTER PACK (50268-797-11) 50 blister pack 2021-02-19 0000-00-00 No No Current