Home NDC 58914-790 Urso Forte
Product NDC 58914-790
11-digit product format 589140790
Labeler code 58914
Product ID 58914-790_06904c03-cea9-4532-8e27-7f2246be613b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ursodiol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Allergan, Inc.
Application NDA020675
Marketing category NDA
Marketing start 1997-12-10
Substance URSODIOL
Active strength 500 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 N020675-001 URSO 250 URSODIOL 250MG TABLET / ORAL RLD 1997-12-10 N020675-002 URSO FORTE URSODIOL 500MG TABLET / ORAL RLD 2004-07-21
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 N020675-001 URSO 250 250MG TABLET / ORAL RLD 1997-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020675-002 URSO FORTE 500MG TABLET / ORAL RLD 2004-07-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020675-001 URSO 250 250MG TABLET / ORAL RLD 1997-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020675-002 URSO FORTE 500MG TABLET / ORAL RLD 2004-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020675-001 URSO 250 250MG TABLET / ORAL RLD 1997-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020675-002 URSO FORTE 500MG TABLET / ORAL RLD 2004-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020675-001 URSO 250 250MG TABLET / ORAL RLD 1997-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020675-002 URSO FORTE 500MG TABLET / ORAL RLD 2004-07-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Urso Forte
Listing expiration 2026-12-31 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858733 Internal RxNorm lookup 858735 Internal RxNorm lookup 858751 Internal RxNorm lookup 858752 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 58914-790-01 Urso Forte 4 in 1 BLISTER PACK TABLET, FILM COATED 4 19 58914-790-10 Urso Forte 100 in 1 BOTTLE TABLET, FILM COATED 100 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Ursodiol ACTIVE INGREDIENT 724L30Y2QR URSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.] 7 Ursodiol ACTIVE MOIETY 724L30Y2QR URSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.] 7 Carnauba wax INACTIVE INGREDIENT R12CBM0EIZ URSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.] 7 Cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U URSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.] 7 Dibutyl sebacate INACTIVE INGREDIENT 4W5IH7FLNY URSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.] 7 Ethylcelluloses INACTIVE INGREDIENT 7Z8S9VYZ4B URSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.] 7 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO URSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.] 7 Magnesium stearate INACTIVE INGREDIENT 70097M6I30 URSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.] 7 Polyethylene glycol 3350 INACTIVE INGREDIENT G2M7P15E5P URSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.] 7 Polyethylene glycol 8000 INACTIVE INGREDIENT Q662QK8M3B URSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.] 7 Povidone K29/32 INACTIVE INGREDIENT 390RMW2PEQ URSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.] 7 sodium starch glycolate type a potato INACTIVE INGREDIENT 5856J3G2A2 URSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58914-790 URSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [ALLERGAN, INC.] 18 Current NDC, Legacy NDC, 2 package rows 20240920_e8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a61.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 Marketing start Marketing end Sample Exclude flag Status 58914-790-01 58914079001 4 TABLET, FILM COATED in 1 BLISTER PACK (58914-790-01) 1997-12-10 0000-00-00 Yes No Current 58914-790-10 58914079010 100 TABLET, FILM COATED in 1 BOTTLE (58914-790-10) 1997-12-10 0000-00-00 No No Current