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United States · US · US:64764-805_2021e7fb-108a-4783-9a37-8bc05bf28b28
Rozerem
In shortageOrange BookUNIISPLATC N05CH02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeN05CH02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116476480510100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10)
- ndc11647648053030 TABLET, FILM COATED in 1 BOTTLE (64764-805-30)
Annotations
UNII (FDA Substance ID)
901AS54I69
RAMELTEON
RxCUI 596205
Orange Book
N021782
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ramelteon Tablet
Raw payload (JSON)
{
"unii": {
"unii": "901AS54I69",
"rxcui": "596205",
"inchikey": "YLXDSYKOBKBWJQ-LBPRGKRZSA-N",
"display_name": "RAMELTEON",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"9de82310-70e8-47b9-b1fc-6c6848b99455": {
"match": "brand_token",
"title": "ROZEREM (RAMELTEON) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
"spl_version": "20",
"published_date": "2026-04-27"
}
},
"productid": "64764-805_2021e7fb-108a-4783-9a37-8bc05bf28b28",
"productndc": "64764-805",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "021782",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "8MG",
"product_no": "001",
"approval_date": "Jul 22, 2005"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RAMELTEON",
"shortage_reason": "Ramelteon Tablet",
"shortage_status": "current",
"proprietary_name": "Rozerem",
"active_ingred_unit": "mg/1",
"application_number": "NDA021782",
"marketing_category": "NDA",
"nonproprietary_name": "ramelteon",
"start_marketing_date": "20050722",
"active_numerator_strength": "8"
}Related drugs
Other records sharing ATC code N05CH02.
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