🇺🇸
United States · US · US:39822-9300_35a58769-c6cf-8c56-e063-6394a90a9857
Dehydrated Alcohol
Orange BookUNIISPLATC D08AX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXGen Pharmaceuticals DJB, Inc.
CountryUS (United States)
ATC codeD08AX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11398229300210 AMPULE in 1 CARTON (39822-9300-2) / 5 mL in 1 AMPULE (39822-9300-1)
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": "39822-9300_35a58769-c6cf-8c56-e063-6394a90a9857",
"productndc": "39822-9300",
"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
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