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United States · US · US:69238-2548_071804f4-9647-4a4d-a394-55b9e976dc9f
Tasimelteon
Orange BookUNIISPLATC N05CH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeN05CH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11692382548330 CAPSULE in 1 BOTTLE (69238-2548-3)
Annotations
UNII (FDA Substance ID)
SHS4PU80D9
TASIMELTEON
RxCUI 1490468
Orange Book
A211654
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": "69238-2548_071804f4-9647-4a4d-a394-55b9e976dc9f",
"productndc": "69238-2548",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "211654",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Jan 12, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TASIMELTEON",
"proprietary_name": "Tasimelteon",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211654",
"marketing_category": "ANDA",
"nonproprietary_name": "Tasimelteon",
"start_marketing_date": "20230224",
"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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