Home NDC 68462-474 Ursodiol
Product NDC 68462-474
11-digit product format 684620474
Labeler code 68462
Product ID 68462-474_71c17751-51cb-411d-b90b-4b98ad4a768e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ursodiol
Dosage form TABLET
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA090801
Marketing category ANDA
Marketing start 2011-07-12
Substance URSODIOL
Active strength 500 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090801-001 URSODIOL URSODIOL 250MG TABLET / ORAL AB 2011-07-12 A090801-002 URSODIOL URSODIOL 500MG TABLET / ORAL AB 2011-07-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 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 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090801-001 URSODIOL 250MG TABLET / ORAL AB 2011-07-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090801-002 URSODIOL 500MG TABLET / ORAL AB 2011-07-12 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ursodiol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength URSODIOL 500 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858733 Internal RxNorm lookup 858751 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 68462-474-01 Ursodiol 100 in 1 BOTTLE TABLET 100 13 68462-474-05 Ursodiol 500 in 1 BOTTLE TABLET 500 13 68462-474-30 Ursodiol 30 in 1 BOTTLE TABLET 30 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded URSODIOL ACTIVE INGREDIENT 724L30Y2QR URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 URSODIOL ACTIVE MOIETY 724L30Y2QR URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 DIBUTYL SEBACATE INACTIVE INGREDIENT 4W5IH7FLNY URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 ETHYLCELLULOSES INACTIVE INGREDIENT 7Z8S9VYZ4B URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 POVIDONES INACTIVE INGREDIENT FZ989GH94E URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-474 URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] 12 Current NDC, Legacy NDC, 3 package rows 20230224_fb79b62a-b450-4d7a-be28-5ee4d174fd58.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 68462-474-01 68462047401 100 TABLET in 1 BOTTLE (68462-474-01) 100 tablet 2011-07-12 0000-00-00 No No Current 68462-474-05 68462047405 500 TABLET in 1 BOTTLE (68462-474-05) 500 tablet 2011-07-12 0000-00-00 No No Current 68462-474-30 68462047430 30 TABLET in 1 BOTTLE (68462-474-30) 30 tablet 2011-07-12 0000-00-00 No No Current