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United States · US · US:55579-306_462e1f5b-024d-3dcb-e063-6294a90a9520

Dehydrated Alcohol

Orange BookUNIISPLATC D08AX08

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

Identification

ManufacturerSolupharm Pharmazeutische Erzeugnisse GmbH
CountryUS (United States)
ATC codeD08AX08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5557930605
    5 mL in 1 BOX (55579-306-05)
  • ndc11
    5557930641
    5 mL in 1 VIAL, SINGLE-USE (55579-306-41)

Annotations

UNII (FDA Substance ID)
3K9958V90M
ALCOHOL
RxCUI 448
Orange Book
A219569
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": "55579-306_462e1f5b-024d-3dcb-e063-6294a90a9520",
  "productndc": "55579-306",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "219569",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "99% (5ML)",
        "product_no": "001",
        "approval_date": "Jul 9, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALCOHOL",
  "proprietary_name": "Dehydrated Alcohol",
  "active_ingred_unit": "mL/mL",
  "application_number": "ANDA219569",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ALCOHOL",
  "start_marketing_date": "20250108",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code D08AX08.

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