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United States · US · US:72266-248_187381ab-f66f-7a22-e063-6294a90a262a

Sincalide

Orange BookUNIISPLATC V04CC03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerFOSUN PHARMA USA INC
CountryUS (United States)
ATC codeV04CC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7226624805
    5 VIAL in 1 PACKAGE (72266-248-05) / 5 mL in 1 VIAL (72266-248-01)

Annotations

UNII (FDA Substance ID)
M03GIQ7Z6P
SINCALIDE
RxCUI 9800
Orange Book
N210850
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": "72266-248_187381ab-f66f-7a22-e063-6294a90a262a",
  "productndc": "72266-248",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "210850",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.005MG/VIAL",
        "product_no": "001",
        "approval_date": "Nov 22, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SINCALIDE",
  "proprietary_name": "Sincalide",
  "active_ingred_unit": "ug/5mL",
  "application_number": "NDA210850",
  "marketing_category": "NDA",
  "nonproprietary_name": "Sincalide",
  "start_marketing_date": "20230109",
  "active_numerator_strength": "5"
}

Related drugs

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