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United States · US · US:50090-7643_3d1f5a98-a243-4cb4-b59d-6059ba0af173

Dehydrated Alcohol

Orange BookUNIISPLATC D08AX08

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeD08AX08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5009076430
    1 AMPULE in 1 CARTON (50090-7643-0) / 5 mL in 1 AMPULE
  • ndc11
    5009076431
    2 AMPULE in 1 CARTON (50090-7643-1) / 5 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)
3K9958V90M
ALCOHOL
RxCUI 448
Orange Book
A219400
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": "50090-7643_3d1f5a98-a243-4cb4-b59d-6059ba0af173",
  "productndc": "50090-7643",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "219400",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "99% (5ML)",
        "product_no": "001",
        "approval_date": "Jun 23, 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": "ANDA219400",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Alcohol",
  "start_marketing_date": "20250624",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code D08AX08.

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