🇺🇸
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
- ndc11829834261010 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"strength": "99% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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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