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United States · US · US:82983-426_be0bec74-c6a7-49e7-931f-69d289cb366f

Dehydrated Alcohol

Orange BookUNIISPLATC D08AX08

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

Identification

ManufacturerAjenat Pharmaceuticals LLC
CountryUS (United States)
ATC codeD08AX08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8298342610
    10 VIAL in 1 CARTON (82983-426-10) / 5 mL in 1 VIAL (82983-426-01)

Annotations

UNII (FDA Substance ID)
3K9958V90M
ALCOHOL
RxCUI 448
Orange Book
N207987
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3K9958V90M",
    "rxcui": "448",
    "inchikey": "LFQSCWFLJHTTHZ-UHFFFAOYSA-N",
    "display_name": "ALCOHOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "PERCUTANEOUS",
  "spl_meta": {
    "07fa92f7-d752-42e3-a572-b552461c4389": {
      "match": "brand_token",
      "title": "DEHYDRATED ALCOHOL (ALCOHOL) INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.]",
      "spl_version": "5",
      "published_date": "2026-05-25"
    }
  },
  "productid": "82983-426_be0bec74-c6a7-49e7-931f-69d289cb366f",
  "productndc": "82983-426",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "207987",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jun 21, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "99% (5ML)",
        "product_no": "002",
        "approval_date": "Jun 21, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALCOHOL",
  "proprietary_name": "Dehydrated Alcohol",
  "active_ingred_unit": "mL/mL",
  "application_number": "NDA207987",
  "marketing_category": "NDA",
  "nonproprietary_name": "Alcohol",
  "start_marketing_date": "20250815",
  "active_numerator_strength": "1"
}

Related drugs

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