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United States · US · US:43068-220_3248eef5-6bad-4844-a6f9-2f5fddd39c8d
Hetlioz
Orange BookUNIIATC N05CH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerVanda Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN05CH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11430682200130 CAPSULE in 1 BOTTLE (43068-220-01)
Annotations
UNII (FDA Substance ID)
SHS4PU80D9
TASIMELTEON
RxCUI 1490468
Orange Book
N205677
AB
Raw payload (JSON)
{
"unii": {
"unii": "SHS4PU80D9",
"rxcui": "1490468",
"inchikey": "PTOIAAWZLUQTIO-GXFFZTMASA-N",
"display_name": "TASIMELTEON",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"productid": "43068-220_3248eef5-6bad-4844-a6f9-2f5fddd39c8d",
"productndc": "43068-220",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "205677",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Jan 31, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TASIMELTEON",
"proprietary_name": "Hetlioz",
"active_ingred_unit": "mg/1",
"application_number": "NDA205677",
"marketing_category": "NDA",
"nonproprietary_name": "tasimelteon",
"start_marketing_date": "20140404",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N05CH03.
- FIHetliozVanda Pharmaceuticals Netherlands B.V.
- DKHetliozVanda Pharmaceuticals NL B.V. Vanda Pharmaceuticals Netherland
- ISHetliozVanda Pharmaceuticals Netherlands B.V.
- 🇺🇸HetliozVanda Pharmaceuticals Inc.
- PLHetliozVanda Pharmaceuticals Netherlands B.V.
- CZHETLIOZVanda Pharmaceuticals Netherlands B.V., Amsterdam
- BEHetlioz 20 mgVanda Pharmaceuticals Netherlands
- IEHETLIOZ 20 mg hard capsulesVanda Pharmaceuticals Netherlands B.V.
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