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United States · US · US:65219-800_8d8838c0-3c0c-4732-ade1-12f76001c50b

Diprivan

Orange BookUNIISPLATC N01AX10

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeN01AX10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6521980010
    10 VIAL in 1 CARTON (65219-800-10) / 20 mL in 1 VIAL (65219-800-01)

Annotations

UNII (FDA Substance ID)
YI7VU623SF
PROPOFOL
RxCUI 8782
Orange Book
N019627
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "YI7VU623SF",
    "rxcui": "8782",
    "inchikey": "OLBCVFGFOZPWHH-UHFFFAOYSA-N",
    "display_name": "PROPOFOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "e3105799-a4b6-f3f4-e6e2-b2b29bbdb538": {
      "match": "brand_token",
      "title": "DIPRIVAN (PROPOFOL) INJECTION, EMULSION [FRESENIUS KABI USA, LLC]",
      "spl_version": "10",
      "published_date": "2025-09-22"
    }
  },
  "productid": "65219-800_8d8838c0-3c0c-4732-ade1-12f76001c50b",
  "productndc": "65219-800",
  "dosage_form": "INJECTION, EMULSION",
  "orange_book": {
    "appl_no": "019627",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Oct 2, 1989"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG/ML",
        "product_no": "002",
        "approval_date": "Jun 11, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROPOFOL",
  "proprietary_name": "Diprivan",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019627",
  "marketing_category": "NDA",
  "nonproprietary_name": "PROPOFOL",
  "start_marketing_date": "20200113",
  "active_numerator_strength": "10"
}

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