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United States · US · US:25021-608_24f96546-ad32-43ca-be91-5536e26d4137

propofol

Orange BookUNIISPLATC N01AX10

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

Identification

ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeN01AX10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2502160820
    25 VIAL in 1 CARTON (25021-608-20) / 20 mL in 1 VIAL
  • ndc11
    2502160850
    20 VIAL in 1 CARTON (25021-608-50) / 50 mL in 1 VIAL
  • ndc11
    2502160851
    10 VIAL in 1 CARTON (25021-608-51) / 100 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
YI7VU623SF
PROPOFOL
RxCUI 8782
Orange Book
A075102
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": {
    "9ba70032-40c2-41c5-9f99-d1f94032d3dc": {
      "match": "brand_token",
      "title": "PROPOFOL INJECTION, EMULSION [CIVICA, INC]",
      "spl_version": "7",
      "published_date": "2026-05-20"
    }
  },
  "productid": "25021-608_24f96546-ad32-43ca-be91-5536e26d4137",
  "productndc": "25021-608",
  "dosage_form": "INJECTION, EMULSION",
  "orange_book": {
    "appl_no": "075102",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Jan 4, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROPOFOL",
  "proprietary_name": "propofol",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA075102",
  "marketing_category": "ANDA",
  "nonproprietary_name": "propofol",
  "start_marketing_date": "20140701",
  "active_numerator_strength": "10"
}

Related drugs

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