Home NDC 65649-651 Uceris
Product NDC 65649-651
11-digit product format 656490651
Labeler code 65649
Product ID 65649-651_205783ee-5004-4fcb-a9d6-ce1ac824357c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name budesonide
Dosage form AEROSOL, FOAM
Route RECTAL
Labeler Salix Pharmaceuticals, Inc.
Application NDA205613
Marketing category NDA
Marketing start 2014-12-01
Substance BUDESONIDE
Active strength 2 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 1 .
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 N205613-001 UCERIS BUDESONIDE 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD 2014-10-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N205613-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD 2014-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD 2014-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD 2014-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD 2014-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD 2014-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD 2014-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD 2014-10-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD 2014-10-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD 2014-10-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD 2014-10-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD 2014-10-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD 2014-10-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD, RS 2014-10-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD, RS 2014-10-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD, RS 2014-10-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD, RS 2014-10-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD, RS 2014-10-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD, RS 2014-10-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD, RS 2014-10-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD, RS 2014-10-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD, RS 2014-10-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL AB RLD, RS 2014-10-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205613-001 UCERIS 2MG/ACTUATION AEROSOL, FOAM / RECTAL RLD, RS 2014-10-07 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Uceris
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUDESONIDE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q3OKS62Q6X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1596778 Internal RxNorm lookup 1596779 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 65649-651-02 Uceris 1 in 1 CANISTER AEROSOL, FOAM 1 21 65649-651-03 Uceris 2 in 1 CARTON AEROSOL, FOAM 2 21
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65649-651 UCERIS (BUDESONIDE) AEROSOL, FOAM [SALIX PHARMACEUTICALS, INC.] 20 Current NDC, Legacy NDC, 2 package rows 20210501_230e4596-2a9b-4d55-b0a0-0cabbcff5289.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 65649-651-02 65649065102 1 in 1 CANISTER Historical 65649-651-03 65649065103 2 CANISTER in 1 CARTON (65649-651-03) / 1 AEROSOL, FOAM in 1 CANISTER (65649-651-02) 2 canister 2014-12-01 0000-00-00 No No Current