Home NDC 68012-309-02 Uceris
Product NDC 68012-309
Requested package NDC 68012-309-02
11-digit product format 680120309
Labeler code 68012
Product ID 68012-309_250346dc-e6de-b148-e063-6394a90a1ca3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name budesonide
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Santarus Inc.
Application NDA203634
Marketing category NDA
Marketing start 2013-01-14
Substance BUDESONIDE
Active strength 9 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 N203634-001 UCERIS BUDESONIDE 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N203634-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203634-001 10307375 2031-09-07 Drug product 2019-06-14 N203634-001 10660858 2031-09-07 Drug product 2020-07-21 N203634-001 8895064 2031-09-07 Drug product 2014-11-25 N203634-001 9132093 2031-09-07 Drug product 2015-09-16 N203634-001 9192581 2031-09-07 U-1325 Drug product 2015-12-03
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.
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 2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 cb3db0bc1861…2026-08-01 22:54:32 2026-06 N203634-001 UCERIS 9MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2013-01-14 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 6 · 201 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203634-001 10307375 2031-09-07 Drug product 2019-06-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203634-001 10660858 2031-09-07 Drug product 2020-07-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203634-001 8895064 2031-09-07 Drug product 2014-11-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203634-001 9132093 2031-09-07 Drug product 2015-09-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203634-001 9192581 2031-09-07 U-1325 Drug product 2015-12-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203634-001 10307375 2031-09-07 Drug product 2019-06-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N203634-001 10660858 2031-09-07 Drug product 2020-07-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N203634-001 8895064 2031-09-07 Drug product 2014-11-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N203634-001 9132093 2031-09-07 Drug product 2015-09-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N203634-001 9192581 2031-09-07 U-1325 Drug product 2015-12-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203634-001 10307375 2031-09-07 Drug product 2019-06-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203634-001 10660858 2031-09-07 Drug product 2020-07-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203634-001 8895064 2031-09-07 Drug product 2014-11-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203634-001 9132093 2031-09-07 Drug product 2015-09-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203634-001 9192581 2031-09-07 U-1325 Drug product 2015-12-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203634-001 10307375 2031-09-07 Drug product 2019-06-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N203634-001 10660858 2031-09-07 Drug product 2020-07-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N203634-001 8895064 2031-09-07 Drug product 2014-11-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N203634-001 9132093 2031-09-07 Drug product 2015-09-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N203634-001 9192581 2031-09-07 U-1325 Drug product 2015-12-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203634-001 10307375 2031-09-07 Drug product 2019-06-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N203634-001 10660858 2031-09-07 Drug product 2020-07-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N203634-001 8895064 2031-09-07 Drug product 2014-11-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N203634-001 9132093 2031-09-07 Drug product 2015-09-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N203634-001 9192581 2031-09-07 U-1325 Drug product 2015-12-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203634-001 10064878 2020-06-09 U-1325 Drug product 2018-09-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203634-001 10105374 2020-06-09 U-1325 Drug product 2018-11-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203634-001 10143698 2020-06-09 U-1325 Drug product 2018-12-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203634-001 7410651 2020-06-09 U-1325 Drug product 2013-01-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203634-001 7431943 2020-06-09 Drug product 2013-01-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203634-001 8293273 2020-06-09 Drug product 2013-01-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203634-001 8784888 2020-06-09 Drug product 2014-07-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203634-001 9320716 2020-06-09 U-1325 Drug product 2016-05-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203634-001 9532954 2020-06-09 U-1325 Drug product 2017-01-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203634-001 RE43799 2020-06-09 U-1325 Drug product 2013-01-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203634-001 10307375 2031-09-07 Drug product 2019-06-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203634-001 8895064 2031-09-07 Drug product 2014-11-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203634-001 9132093 2031-09-07 Drug product 2015-09-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N203634-001 9192581 2031-09-07 U-1325 Drug product 2015-12-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203634-001 10307375 2031-09-07 Drug product 2019-06-14 bb7c543d1eb4…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Uceris
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUDESONIDE 9 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 1366550 Internal RxNorm lookup 1366556 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68012-309-01 Uceris 2 in 1 BLISTER PACK TABLET, EXTENDED RELEASE 2 20 68012-309-02 Uceris 2 in 1 BLISTER PACK TABLET, EXTENDED RELEASE 2 20 68012-309-30 Uceris 30 in 1 BOTTLE TABLET, EXTENDED RELEASE 30 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BUDESONIDE ACTIVE INGREDIENT Q3OKS62Q6X UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.] 11 BUDESONIDE ACTIVE MOIETY Q3OKS62Q6X UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.] 11 HYDROXYPROPYL CELLULOSE (TYPE E) INACTIVE INGREDIENT 66O7AQV0RT UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.] 11 LACTOSE INACTIVE INGREDIENT J2B2A4N98G UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.] 11 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.] 11 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.] 11 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.] 11 TALC INACTIVE INGREDIENT 7SEV7J4R1U UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.] 11 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68012-309 UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS INC.] 20 Current NDC, Legacy NDC, 3 package rows 20241023_92cbb190-8851-46ed-bfe0-166ca62ef2e9.zip
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 68012-309-02 68012030902 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-02) 2013-01-14 0000-00-00 No No Current