🇺🇸
United States · US · US:43068-304_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 · 2
- ndc1143068304021 BOTTLE in 1 CARTON (43068-304-02) / 48 mL in 1 BOTTLE
- ndc1143068304061 BOTTLE in 1 CARTON (43068-304-06) / 158 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
SHS4PU80D9
TASIMELTEON
RxCUI 1490468
Orange Book
N214517
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": "43068-304_3248eef5-6bad-4844-a6f9-2f5fddd39c8d",
"productndc": "43068-304",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "214517",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "4MG/ML",
"product_no": "001",
"approval_date": "Dec 1, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TASIMELTEON",
"proprietary_name": "Hetlioz",
"active_ingred_unit": "mg/mL",
"application_number": "NDA214517",
"marketing_category": "NDA",
"nonproprietary_name": "tasimelteon",
"start_marketing_date": "20201210",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code N05CH03.
- DKHetliozVanda Pharmaceuticals NL B.V. Vanda Pharmaceuticals Netherland
- FIHetliozVanda Pharmaceuticals Netherlands B.V.
- 🇺🇸HetliozVanda Pharmaceuticals Inc.
- PLHetliozVanda Pharmaceuticals Netherlands B.V.
- ISHetliozVanda Pharmaceuticals Netherlands B.V.
- CZHETLIOZVanda Pharmaceuticals Netherlands B.V., Amsterdam
- BEHetlioz 20 mgVanda Pharmaceuticals Netherlands
- IEHETLIOZ 20 mg hard capsulesVanda Pharmaceuticals Netherlands B.V.
Access this data programmatically
Query Hetlioz 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.