🇺🇸
United States · US · US:68012-309_250346dc-e6de-b148-e063-6394a90a1ca3
Uceris
Orange BookUNIISPLATC A07EA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSantarus Inc.
CountryUS (United States)
ATC codeA07EA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1168012309012 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-01)
- ndc1168012309022 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-02)
- ndc11680123093030 TABLET, EXTENDED RELEASE in 1 BOTTLE (68012-309-30)
Annotations
UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
N203634
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": "ORAL",
"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": "68012-309_250346dc-e6de-b148-e063-6394a90a1ca3",
"productndc": "68012-309",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "203634",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "9MG",
"product_no": "001",
"approval_date": "Jan 14, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUDESONIDE",
"proprietary_name": "Uceris",
"active_ingred_unit": "mg/1",
"application_number": "NDA203634",
"marketing_category": "NDA",
"nonproprietary_name": "budesonide",
"start_marketing_date": "20130114",
"active_numerator_strength": "9"
}Related drugs
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