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United States · US · US:61168-101_c67c4873-6322-42dc-8a2b-da3a7012a435
KYBELLA
Orange BookUNIISPLATC D11AX24
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKythera Biopharmaceuticals Inc.
CountryUS (United States)
ATC codeD11AX24
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1161168101032 VIAL, GLASS in 1 CARTON (61168-101-03) / 2 mL in 1 VIAL, GLASS
- ndc1161168101044 VIAL, GLASS in 1 CARTON (61168-101-04) / 2 mL in 1 VIAL, GLASS (61168-101-01)
Annotations
UNII (FDA Substance ID)
005990WHZZ
DEOXYCHOLIC ACID
RxCUI 3194
Orange Book
N206333
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "005990WHZZ",
"rxcui": "3194",
"inchikey": "KXGVEGMKQFWNSR-LLQZFEROSA-N",
"display_name": "DEOXYCHOLIC ACID",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553": {
"match": "brand_token",
"title": "KYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]",
"spl_version": "25",
"published_date": "2025-12-31"
}
},
"productid": "61168-101_c67c4873-6322-42dc-8a2b-da3a7012a435",
"productndc": "61168-101",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "206333",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "20MG/2ML (10MG/ML)",
"product_no": "001",
"approval_date": "Apr 29, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEOXYCHOLIC ACID",
"proprietary_name": "KYBELLA",
"active_ingred_unit": "mg/2mL",
"application_number": "NDA206333",
"marketing_category": "NDA",
"nonproprietary_name": "Deoxycholic Acid",
"start_marketing_date": "20150608",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code D11AX24.
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