Back to search
🇺🇸

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

  • ndc11
    0480449056
    30 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

Other records sharing ATC code N05CH03.

Access this data programmatically

Query Tasimelteon 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.