FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUDESONIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3OKS62Q6X
Rxcui1596778, 1596779

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65649-651-02Uceris1 in 1 CANISTERAEROSOL, FOAM121
65649-651-03Uceris2 in 1 CARTONAEROSOL, FOAM221

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65649-651-02GM - Gram65649-6516490bff4-6777-4536-986c-7c4fcc1e0fc012014-12-01
65649-651-03GM - Gram65649-65195c4e5e3-0ef0-4d50-ae09-6231baa5e98312014-12-01

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65649-651UCERIS (BUDESONIDE) AEROSOL, FOAM [SALIX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 2 package rows20210501_230e4596-2a9b-4d55-b0a0-0cabbcff5289.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1596779budesonide 2 MG/ACTUAT Rectal Foam, 14 ACTUATPSN230e4596-2a9b-4d55-b0a0-0cabbcff528921
1596778UCERIS 2 MG/ACTUAT Rectal Foam, 14 ACTUATPSN230e4596-2a9b-4d55-b0a0-0cabbcff528921
159677814 ACTUAT budesonide 2 MG/ACTUAT Rectal Foam [Uceris]SBD230e4596-2a9b-4d55-b0a0-0cabbcff528921
159677914 ACTUAT budesonide 2 MG/ACTUAT Rectal FoamSCD230e4596-2a9b-4d55-b0a0-0cabbcff528921
1596779budesonide 2 MG/ACTUAT Rectal Foam, 14 ACTUATSY230e4596-2a9b-4d55-b0a0-0cabbcff528921
1596778Uceris 2 MG/ACTUAT Rectal Foam, 14 ACTUATSY230e4596-2a9b-4d55-b0a0-0cabbcff528921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65649-651-02656490651021 in 1 CANISTERHistorical
65649-651-03656490651032 CANISTER in 1 CARTON (65649-651-03) / 1 AEROSOL, FOAM in 1 CANISTER (65649-651-02) 2 canister2014-12-010000-00-00NoNoCurrent