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United States · US · US:42806-338_d7c8ea49-c06c-441d-820e-def3920f7c1e
Molindone Hydrochloride
Orange BookUNIISPLATC N05AE02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEPIC PHARMA, LLC
CountryUS (United States)
ATC codeN05AE02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114280633801100 TABLET in 1 BOTTLE (42806-338-01)
Annotations
UNII (FDA Substance ID)
1DWS68PNE6
MOLINDONE HYDROCHLORIDE
RxCUI 82051
Orange Book
A090453
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1DWS68PNE6",
"rxcui": "82051",
"inchikey": "GQWNECFJGBQMBO-UHFFFAOYSA-N",
"display_name": "MOLINDONE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1275e92f-9573-4d0c-8e77-1c9ac47696d2": {
"match": "brand_token",
"title": "MOLINDONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]",
"spl_version": "5",
"published_date": "2025-12-19"
}
},
"productid": "42806-338_d7c8ea49-c06c-441d-820e-def3920f7c1e",
"productndc": "42806-338",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "090453",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Mar 20, 2015"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Mar 20, 2015"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "25MG",
"product_no": "003",
"approval_date": "Mar 20, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MOLINDONE HYDROCHLORIDE",
"proprietary_name": "Molindone Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090453",
"marketing_category": "ANDA",
"nonproprietary_name": "Molindone Hydrochloride",
"start_marketing_date": "20181017",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N05AE02.
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