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United States · US · US:65649-651_205783ee-5004-4fcb-a9d6-ce1ac824357c
Uceris
Orange BookUNIISPLATC A07EA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSalix Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA07EA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165649651032 CANISTER in 1 CARTON (65649-651-03) / 1 AEROSOL, FOAM in 1 CANISTER (65649-651-02)
Annotations
UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
N205613
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Q3OKS62Q6X",
"rxcui": "19831",
"inchikey": "VOVIALXJUBGFJZ-KWVAZRHASA-N",
"display_name": "BUDESONIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "RECTAL",
"spl_meta": {
"230e4596-2a9b-4d55-b0a0-0cabbcff5289": {
"match": "brand_token",
"title": "UCERIS (BUDESONIDE) AEROSOL, FOAM [SALIX PHARMACEUTICALS, INC.]",
"spl_version": "21",
"published_date": "2025-11-27"
}
},
"productid": "65649-651_205783ee-5004-4fcb-a9d6-ce1ac824357c",
"productndc": "65649-651",
"dosage_form": "AEROSOL, FOAM",
"orange_book": {
"appl_no": "205613",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "2MG/ACTUATION",
"product_no": "001",
"approval_date": "Oct 7, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUDESONIDE",
"proprietary_name": "Uceris",
"active_ingred_unit": "mg/1",
"application_number": "NDA205613",
"marketing_category": "NDA",
"nonproprietary_name": "budesonide",
"start_marketing_date": "20141201",
"active_numerator_strength": "2"
}Related drugs
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