Home NDC 0527-1326 Ursodiol
Product NDC 0527-1326
11-digit product format 005271326
Labeler code 0527
Product ID 0527-1326_2a1b76c4-6aa9-4132-ae02-177791eb7560
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ursodiol
Dosage form CAPSULE
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA079082
Marketing category ANDA
Marketing start 2009-01-01
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079082-001 URSODIOL URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079082-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ursodiol
Listing expiration 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0527-1326-01 Ursodiol 100 in 1 BOTTLE CAPSULE 100 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded URSODIOL ACTIVE INGREDIENT 724L30Y2QR URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 URSODIOL ACTIVE MOIETY 724L30Y2QR URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 ALCOHOL INACTIVE INGREDIENT 3K9958V90M URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 GELATIN INACTIVE INGREDIENT 2G86QN327L URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 METHYL ALCOHOL INACTIVE INGREDIENT Y4S76JWI15 URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 SHELLAC INACTIVE INGREDIENT 46N107B71O URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP URSODIOL CAPSULE [LANNETT COMPANY, INC.] 6 URSODIOL ACTIVE INGREDIENT 724L30Y2QR URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1 URSODIOL ACTIVE MOIETY 724L30Y2QR URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1 METHYL ALCOHOL INACTIVE INGREDIENT Y4S76JWI15 URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-1326 URSODIOL CAPSULE [LANNETT COMPANY, INC.] 15 Current NDC, Legacy NDC, 1 package rows 20240704_2e799e93-b5a0-40f7-95c5-b40d8a948a0d.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 0527-1326-01 00527132601 100 CAPSULE in 1 BOTTLE (0527-1326-01) 100 capsule 2009-01-01 0000-00-00 No No Current