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United States · US · US:63323-579_7aa01e72-178a-4161-b41b-f05bc8eba1a0
SINCALIDE
Orange BookUNIISPLATC V04CC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeV04CC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11633235790510 VIAL in 1 PACKAGE (63323-579-05) / 5 mL in 1 VIAL (63323-579-01)
Annotations
UNII (FDA Substance ID)
M03GIQ7Z6P
SINCALIDE
RxCUI 9800
Orange Book
N017697
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "M03GIQ7Z6P",
"rxcui": "9800",
"inchikey": "IZTQOLKUZKXIRV-YRVFCXMDSA-N",
"display_name": "SINCALIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"efbc189e-f5f8-0ac7-e053-2995a90a68a9": {
"match": "brand_token",
"title": "SINCALIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FOSUN PHARMA USA INC]",
"spl_version": "3",
"published_date": "2024-05-16"
}
},
"productid": "63323-579_7aa01e72-178a-4161-b41b-f05bc8eba1a0",
"productndc": "63323-579",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "017697",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "0.005MG/VIAL",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SINCALIDE",
"proprietary_name": "SINCALIDE",
"active_ingred_unit": "ug/5mL",
"application_number": "NDA017697",
"marketing_category": "NDA",
"nonproprietary_name": "sincalide",
"start_marketing_date": "20230401",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code V04CC03.
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