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United States · US · US:0527-4125_aac4561c-b9ba-4d3a-b86c-be120e4593dc
DRONABINOL
Orange BookUNIISPLATC A04AD10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeA04AD10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11052741253560 CAPSULE in 1 BOTTLE (0527-4125-35)
Annotations
UNII (FDA Substance ID)
7J8897W37S
DRONABINOL
RxCUI 10402
Orange Book
A207421
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7J8897W37S",
"rxcui": "10402",
"inchikey": "CYQFCXCEBYINGO-IAGOWNOFSA-N",
"display_name": "DRONABINOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"fd8c5d57-0173-4f62-8ff0-d8147986a976": {
"match": "brand_token",
"title": "DRONABINOL CAPSULE [MAJOR PHARMACEUTICALS]",
"spl_version": "6",
"published_date": "2026-05-21"
}
},
"productid": "0527-4125_aac4561c-b9ba-4d3a-b86c-be120e4593dc",
"productndc": "0527-4125",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "207421",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Feb 7, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "002",
"approval_date": "Feb 7, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "003",
"approval_date": "Feb 7, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DRONABINOL",
"proprietary_name": "DRONABINOL",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207421",
"marketing_category": "ANDA",
"nonproprietary_name": "dronabinol",
"start_marketing_date": "20200210",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code A04AD10.
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