Home NDC 72887-143 Ursodiol 200 mg
Product NDC 72887-143
11-digit product format 728870143
Labeler code 72887
Product ID 72887-143_c28d41e2-14c2-4401-87ab-49b32239caba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ursodiol
Dosage form CAPSULE
Route ORAL
Labeler FH2 Pharma LLC
Application ANDA205789
Marketing category ANDA
Marketing start 2021-11-18
Substance URSODIOL
Active strength 200 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 A205789-001 URSODIOL URSODIOL 200MG CAPSULE / ORAL 2020-05-08 A205789-002 URSODIOL URSODIOL 400MG CAPSULE / ORAL 2020-05-08
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 A205789-001 URSODIOL 200MG CAPSULE / ORAL 2020-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205789-002 URSODIOL 400MG CAPSULE / ORAL 2020-05-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205789-001 URSODIOL 200MG CAPSULE / ORAL RS 2020-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205789-001 URSODIOL 200MG CAPSULE / ORAL RS 2020-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205789-001 URSODIOL 200MG CAPSULE / ORAL RS 2020-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205789-001 URSODIOL 200MG CAPSULE / ORAL RS 2020-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205789-001 URSODIOL 200MG CAPSULE / ORAL RS 2020-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205789-001 URSODIOL 200MG CAPSULE / ORAL RS 2020-05-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205789-001 URSODIOL 200MG CAPSULE / ORAL RS 2020-05-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205789-001 URSODIOL 200MG CAPSULE / ORAL RS 2020-05-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205789-001 URSODIOL 200MG CAPSULE / ORAL RS 2020-05-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205789-001 URSODIOL 200MG CAPSULE / ORAL RS 2020-05-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205789-001 URSODIOL 200MG CAPSULE / ORAL 2020-05-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205789-001 URSODIOL 200MG CAPSULE / ORAL 2020-05-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205789-001 URSODIOL 200MG CAPSULE / ORAL 2020-05-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205789-001 URSODIOL 200MG CAPSULE / ORAL 2020-05-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205789-001 URSODIOL 200MG CAPSULE / ORAL 2020-05-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205789-001 URSODIOL 200MG CAPSULE / ORAL 2020-05-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205789-001 URSODIOL 200MG CAPSULE / ORAL 2020-05-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A205789-001 URSODIOL 200MG CAPSULE / ORAL 2020-05-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205789-001 URSODIOL 200MG CAPSULE / ORAL 2020-05-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A205789-002 URSODIOL 400MG CAPSULE / ORAL RS 2020-05-08 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base Ursodiol 200 mg
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength URSODIOL 200 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 412174 Internal RxNorm lookup 2376942 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 72887-143-06 Ursodiol 200 mg 60 in 1 BOTTLE CAPSULE 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72887-143 URSODIOL 200 MG (URSODIOL) CAPSULE URSODIOL 400 MG (URSODIOL) CAPSULE [FH2 PHARMA LLC] 3 Current NDC, Legacy NDC, 1 package rows 20240101_476179dc-b410-4305-881b-470511765647.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 72887-143-06 72887014306 60 CAPSULE in 1 BOTTLE (72887-143-06) 60 capsule 2021-11-18 0000-00-00 No No Current