Home NDC 42806-503 Ursodiol
Product NDC 42806-503
11-digit product format 428060503
Labeler code 42806
Product ID 42806-503_392c277e-5bc5-46c7-b2f2-8b48baaa6f83
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ursodiol
Dosage form CAPSULE
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA075517
Marketing category ANDA
Marketing start 2010-07-16
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 42 .
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 A075517-001 URSODIOL URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075517-001 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 · 42 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 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075517-001 URSODIOL 300MG CAPSULE / ORAL AB 2000-03-14 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42806-503-01 Ursodiol 100 in 1 BOTTLE CAPSULE 100 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded URSODIOL ACTIVE INGREDIENT 724L30Y2QR URSODIOL CAPSULE [EPIC PHARMA, LLC] 9 URSODIOL ACTIVE MOIETY 724L30Y2QR URSODIOL CAPSULE [EPIC PHARMA, LLC] 9 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH URSODIOL CAPSULE [EPIC PHARMA, LLC] 9 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G URSODIOL CAPSULE [EPIC PHARMA, LLC] 9 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD URSODIOL CAPSULE [EPIC PHARMA, LLC] 9 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK URSODIOL CAPSULE [EPIC PHARMA, LLC] 9 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA URSODIOL CAPSULE [EPIC PHARMA, LLC] 9 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 URSODIOL CAPSULE [EPIC PHARMA, LLC] 9 GELATIN INACTIVE INGREDIENT 2G86QN327L URSODIOL CAPSULE [EPIC PHARMA, LLC] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 URSODIOL CAPSULE [EPIC PHARMA, LLC] 9 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 URSODIOL CAPSULE [EPIC PHARMA, LLC] 9 SHELLAC INACTIVE INGREDIENT 46N107B71O URSODIOL CAPSULE [EPIC PHARMA, LLC] 9 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 URSODIOL CAPSULE [EPIC PHARMA, LLC] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ URSODIOL CAPSULE [EPIC PHARMA, LLC] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP URSODIOL CAPSULE [EPIC PHARMA, LLC] 9 URSODIOL ACTIVE INGREDIENT 724L30Y2QR URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] 2 URSODIOL ACTIVE INGREDIENT 724L30Y2QR URSODIOL (URSODIOL) CAPSULE [AVPAK] 2 URSODIOL ACTIVE MOIETY 724L30Y2QR URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] 2 URSODIOL ACTIVE MOIETY 724L30Y2QR URSODIOL (URSODIOL) CAPSULE [AVPAK] 2 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH URSODIOL (URSODIOL) CAPSULE [AVPAK] 2 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G URSODIOL (URSODIOL) CAPSULE [AVPAK] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD URSODIOL (URSODIOL) CAPSULE [AVPAK] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK URSODIOL (URSODIOL) CAPSULE [AVPAK] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA URSODIOL (URSODIOL) CAPSULE [AVPAK] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 URSODIOL (URSODIOL) CAPSULE [AVPAK] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L URSODIOL (URSODIOL) CAPSULE [AVPAK] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 URSODIOL (URSODIOL) CAPSULE [AVPAK] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 URSODIOL (URSODIOL) CAPSULE [AVPAK] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ URSODIOL (URSODIOL) CAPSULE [AVPAK] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP URSODIOL (URSODIOL) CAPSULE [AVPAK] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] 2 URSODIOL ACTIVE INGREDIENT 724L30Y2QR URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 URSODIOL ACTIVE MOIETY 724L30Y2QR URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-503 URSODIOL CAPSULE [EPIC PHARMA, LLC] 17 Current NDC, Legacy NDC, 1 package rows 20241222_e47b49ca-bde9-448a-bf61-f943c2aa5b8e.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 · 5 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 42806-503-01 42806050301 100 CAPSULE in 1 BOTTLE (42806-503-01) 100 capsule 2010-07-16 0000-00-00 No No Current