🇺🇸
United States · US · US:60505-4665_5fdd9cbd-360f-3787-3863-c1172763840f
Tasimelteon
Orange BookUNIISPLATC N05CH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeN05CH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11605054665330 CAPSULE in 1 BOTTLE (60505-4665-3)
- ndc11605054665990 CAPSULE in 1 BOTTLE (60505-4665-9)
Annotations
UNII (FDA Substance ID)
SHS4PU80D9
TASIMELTEON
RxCUI 1490468
Orange Book
A211607
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "SHS4PU80D9",
"rxcui": "1490468",
"inchikey": "PTOIAAWZLUQTIO-GXFFZTMASA-N",
"display_name": "TASIMELTEON",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"46b09064-a675-92d5-24a7-dac0410f77ae": {
"match": "brand_token",
"title": "TASIMELTEON CAPSULE [APOTEX CORP.]",
"spl_version": "2",
"published_date": "2025-04-11"
}
},
"productid": "60505-4665_5fdd9cbd-360f-3787-3863-c1172763840f",
"productndc": "60505-4665",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "211607",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Dec 20, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TASIMELTEON",
"proprietary_name": "Tasimelteon",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211607",
"marketing_category": "ANDA",
"nonproprietary_name": "Tasimelteon",
"start_marketing_date": "20240105",
"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.
- 🇺🇸HetliozVanda Pharmaceuticals Inc.
- PLHetliozVanda Pharmaceuticals Netherlands B.V.
- CZHETLIOZVanda Pharmaceuticals Netherlands B.V., Amsterdam
- BEHetlioz 20 mgVanda Pharmaceuticals Netherlands
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