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United States · US · US:0480-4490_742d1ad6-c92e-4d2c-9d23-c5616751c5dc
Tasimelteon
Orange BookUNIISPLATC N05CH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN05CH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11048044905630 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-4490-56)
Annotations
UNII (FDA Substance ID)
SHS4PU80D9
TASIMELTEON
RxCUI 1490468
Orange Book
A211601
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": "0480-4490_742d1ad6-c92e-4d2c-9d23-c5616751c5dc",
"productndc": "0480-4490",
"dosage_form": "CAPSULE, GELATIN COATED",
"orange_book": {
"appl_no": "211601",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Dec 12, 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": "ANDA211601",
"marketing_category": "ANDA",
"nonproprietary_name": "Tasimelteon",
"start_marketing_date": "20221229",
"active_numerator_strength": "20"
}Related drugs
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- 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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