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United States · US · US:16714-977_d7b2f7ed-e91e-430a-bab2-a9533b90e8b9

propofol

Orange BookUNIISPLATC N01AX10

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

Identification

ManufacturerNorthStar Rx LLC
CountryUS (United States)
ATC codeN01AX10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1671497720
    20 VIAL in 1 CARTON (16714-977-20) / 50 mL in 1 VIAL (16714-977-01)

Annotations

UNII (FDA Substance ID)
YI7VU623SF
PROPOFOL
RxCUI 8782
Orange Book
A206408
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": "16714-977_d7b2f7ed-e91e-430a-bab2-a9533b90e8b9",
  "productndc": "16714-977",
  "dosage_form": "INJECTION, EMULSION",
  "orange_book": {
    "appl_no": "206408",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Oct 12, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROPOFOL",
  "proprietary_name": "propofol",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA206408",
  "marketing_category": "ANDA",
  "nonproprietary_name": "propofol",
  "start_marketing_date": "20220701",
  "active_numerator_strength": "10"
}

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