uceris

Generic: budesonide

Labeler: salix pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name uceris
Generic Name budesonide
Labeler salix pharmaceuticals, inc.
Dosage Form AEROSOL, FOAM
Routes
RECTAL
Active Ingredients

budesonide 2 mg/1

Manufacturer
Salix Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 65649-651
Product ID 65649-651_205783ee-5004-4fcb-a9d6-ce1ac824357c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205613
Listing Expiration 2026-12-31
Marketing Start 2014-12-01

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65649651
Hyphenated Format 65649-651

Supplemental Identifiers

RxCUI
1596778 1596779
UNII
Q3OKS62Q6X
NUI
N0000175576 N0000175450

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name uceris (source: ndc)
Generic Name budesonide (source: ndc)
Application Number NDA205613 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 2 CANISTER in 1 CARTON (65649-651-03) / 1 AEROSOL, FOAM in 1 CANISTER (65649-651-02)
source: ndc

Packages (1)

65649-651-03 2 CANISTER in 1 CARTON (65649-651-03) / 1 AEROSOL, FOAM in 1 CANISTER (65649-651-02)

Ingredients (1)

budesonide (2 mg/1)

Linked Drug Pages (1)

Uceris ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "205783ee-5004-4fcb-a9d6-ce1ac824357c", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["1596778", "1596779"], "spl_set_id": ["230e4596-2a9b-4d55-b0a0-0cabbcff5289"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Salix Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CANISTER in 1 CARTON (65649-651-03)  / 1 AEROSOL, FOAM in 1 CANISTER (65649-651-02)", "package_ndc": "65649-651-03", "marketing_start_date": "20141201"}], "brand_name": "Uceris", "product_id": "65649-651_205783ee-5004-4fcb-a9d6-ce1ac824357c", "dosage_form": "AEROSOL, FOAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "65649-651", "generic_name": "budesonide", "labeler_name": "Salix Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Uceris", "active_ingredients": [{"name": "BUDESONIDE", "strength": "2 mg/1"}], "application_number": "NDA205613", "marketing_category": "NDA", "marketing_start_date": "20141201", "listing_expiration_date": "20261231"}