Home NDC 64380-918 URSODIOL
Product NDC 64380-918
11-digit product format 643800918
Labeler code 64380
Product ID 64380-918_a9f0b231-1cf0-4695-b76c-111dfbe23d39
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ursodiol
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA213504
Marketing category ANDA
Marketing start 2021-02-08
Substance URSODIOL
Active strength 250 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 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 A213504-001 URSODIOL URSODIOL 250MG TABLET / ORAL AB 2020-08-20 A213504-002 URSODIOL URSODIOL 500MG TABLET / ORAL AB 2020-08-20
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 2 · 76 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 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213504-001 URSODIOL 250MG TABLET / ORAL AB 2020-08-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A213504-002 URSODIOL 500MG TABLET / ORAL AB 2020-08-20 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 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 250 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 64380-918-06 URSODIOL 100 in 1 BOTTLE TABLET 100 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-918 URSODIOL TABLET [STRIDES PHARMA SCIENCE LIMITED] 10 Current NDC, Legacy NDC, 1 package rows 20250316_9d666bbc-98c4-445f-a5a2-cad1bcccde4e.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 · 1 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 64380-918-06 64380091806 100 TABLET in 1 BOTTLE (64380-918-06) 100 tablet 2021-02-08 0000-00-00 No No Current