🇺🇸
United States · US · US:85776-201_dcc02ae3-f1fa-431e-81bb-c52d35b81c66
SYNDROS
Orange BookUNIISPLATC A04AD10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWellhouse Pharma, LLC
CountryUS (United States)
ATC codeA04AD10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1185776201301 BOTTLE, GLASS in 1 CARTON (85776-201-30) / 30 mL in 1 BOTTLE, GLASS
Annotations
UNII (FDA Substance ID)
7J8897W37S
DRONABINOL
RxCUI 10402
Orange Book
N205525
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": {
"a7801c70-995d-46a2-91ee-141ef427c6b5": {
"match": "brand_token",
"title": "SYNDROS (DRONABINOL) SOLUTION [BENUVIA OPERATIONS, LLC]",
"spl_version": "9",
"published_date": "2026-04-27"
}
},
"productid": "85776-201_dcc02ae3-f1fa-431e-81bb-c52d35b81c66",
"productndc": "85776-201",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "205525",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Mar 23, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DRONABINOL",
"proprietary_name": "SYNDROS",
"active_ingred_unit": "mg/mL",
"application_number": "NDA205525",
"marketing_category": "NDA",
"nonproprietary_name": "Dronabinol",
"start_marketing_date": "20260416",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code A04AD10.
Access this data programmatically
Query SYNDROS and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.