FDA.reportPublic FDA data

Uceris

Product NDC
68012-309
Requested package NDC
68012-309-30
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N203634-001UCERISBUDESONIDE9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N203634-001AB

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N203634-001103073752031-09-07Drug product2019-06-14
N203634-001106608582031-09-07Drug product2020-07-21
N203634-00188950642031-09-07Drug product2014-11-25
N203634-00191320932031-09-07Drug product2015-09-16
N203634-00191925812031-09-07U-1325Drug product2015-12-03

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N203634-001UCERIS9MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2013-01-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N203634-001AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N203634-001103073752031-09-07Drug product2019-06-14a50c72e98297…
2026-08-01 22:54:322026-06N203634-001106608582031-09-07Drug product2020-07-21a50c72e98297…
2026-08-01 22:54:322026-06N203634-00188950642031-09-07Drug product2014-11-25a50c72e98297…
2026-08-01 22:54:322026-06N203634-00191320932031-09-07Drug product2015-09-16a50c72e98297…
2026-08-01 22:54:322026-06N203634-00191925812031-09-07U-1325Drug product2015-12-03a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
budesonideBUDESONIDEOceanside Pharmaceuticalsa12b2e99-c8b3-4d08-9af0-8c4a4376ebf12024-10-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 203634
application number: NDA203634
UcerisBUDESONIDESantarus Inc.92cbb190-8851-46ed-bfe0-166ca62ef2e92024-10-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 203634
application number: NDA203634
ndc (package): 68012-309-30
ndc (product): 68012-309
ndc11 (package): 68012030930

Additional Listing Data#

Finished product
Yes
Brand name base
Uceris
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUDESONIDE9 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q3OKS62Q6XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1366550Internal RxNorm lookup
1366556Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92cbb190-8851-46ed-bfe0-166ca62ef2e9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7816cdf6-b925-4282-bedd-11ae25d518a1Product name120250116
d17a61d0-e77b-4bcb-ad22-343ff1a3ef4dProduct name220240424
9ab9f611-cedd-47ea-a83c-0489c8c04fc6Product name120231006
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
a03aea00-1d8b-bfad-a82e-f52f68676f63Product name220221216
54a29484-7dde-4771-9547-005149321621Product name120220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743Product name520211018
218c043e-94e5-4e66-a363-d0d446485bc6Product name220210512
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7Product name920210127
da63bc8c-2e89-4044-89d6-1facbff5474eProduct name120200121
899766bc-33ce-8154-910d-12cb0889fb56Product name220150106

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68012-309-012024-01-30C16284748780-11030e364-fc64-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use UCERIS safely and effectively. See full prescribing information for UCERIS. UCERIS ® (budesonide) extended-release tablets, for oral use Initial U.S. Approval: 1997
68012-309-022024-01-30C16284748780-11030e364-fc64-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use UCERIS safely and effectively. See full prescribing information for UCERIS. UCERIS ® (budesonide) extended-release tablets, for oral use Initial U.S. Approval: 1997
68012-309-302024-01-30C16284748780-11030e364-fc64-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use UCERIS safely and effectively. See full prescribing information for UCERIS. UCERIS ® (budesonide) extended-release tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68012-309-01Uceris2 in 1 BLISTER PACKTABLET, EXTENDED RELEASE220
68012-309-02Uceris2 in 1 BLISTER PACKTABLET, EXTENDED RELEASE220
68012-309-30Uceris30 in 1 BOTTLETABLET, EXTENDED RELEASE3020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68012-309-30EA - Each68012-30968850977-ac76-4286-b550-ab12cd4ac6a012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUDESONIDEACTIVE INGREDIENTQ3OKS62Q6XUCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]11
BUDESONIDEACTIVE MOIETYQ3OKS62Q6XUCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UUCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]11
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RTUCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]11
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GUCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]11
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]11
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JUCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]11
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APUCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]11
TALCINACTIVE INGREDIENT7SEV7J4R1UUCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPUCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]11
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMUCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68012-309UCERIS (BUDESONIDE) TABLET, EXTENDED RELEASE [SANTARUS INC.]20Current NDC, Legacy NDC, 3 package rows20241023_92cbb190-8851-46ed-bfe0-166ca62ef2e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366550budesonide 9 MG 24HR Extended Release Oral TabletPSN92cbb190-8851-46ed-bfe0-166ca62ef2e920
1366556Uceris 9 MG 24HR Extended Release Oral TabletPSN92cbb190-8851-46ed-bfe0-166ca62ef2e920
136655624 HR budesonide 9 MG Extended Release Oral Tablet [Uceris]SBD92cbb190-8851-46ed-bfe0-166ca62ef2e920
136655024 HR budesonide 9 MG Extended Release Oral TabletSCD92cbb190-8851-46ed-bfe0-166ca62ef2e920
136655624 HR Uceris 9 MG Extended Release Oral TabletSY92cbb190-8851-46ed-bfe0-166ca62ef2e920
1366550budesonide 9 MG 24 HR Extended Release Oral TabletSY92cbb190-8851-46ed-bfe0-166ca62ef2e920
1366556Uceris 9 MG 24 HR Extended Release Oral TabletSY92cbb190-8851-46ed-bfe0-166ca62ef2e920

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68012-309-306801203093030 TABLET, EXTENDED RELEASE in 1 BOTTLE (68012-309-30) 2013-01-140000-00-00NoNoCurrent