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United States · US · US:76420-880_2bea370a-97da-d286-e063-6294a90aca7f
RAMELTEON
In shortageOrange BookUNIISPLATC N05CH02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeN05CH02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc117642088001100 TABLET, FILM COATED in 1 BOTTLE (76420-880-01)
- ndc11764208803030 TABLET, FILM COATED in 1 BOTTLE (76420-880-30)
- ndc11764208806060 TABLET, FILM COATED in 1 BOTTLE (76420-880-60)
- ndc11764208809090 TABLET, FILM COATED in 1 BOTTLE (76420-880-90)
Annotations
UNII (FDA Substance ID)
901AS54I69
RAMELTEON
RxCUI 596205
Orange Book
A215972
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": {
"5245f9ee-b4ca-24b6-e063-6394a90a0b1b": {
"match": "brand_token",
"title": "RAMELTEON TABLET [AVPAK]",
"spl_version": "2",
"published_date": "2026-05-28"
}
},
"productid": "76420-880_2bea370a-97da-d286-e063-6294a90aca7f",
"productndc": "76420-880",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "215972",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "8MG",
"product_no": "001",
"approval_date": "Jul 10, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RAMELTEON",
"shortage_reason": "Ramelteon Tablet",
"shortage_status": "current",
"proprietary_name": "RAMELTEON",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215972",
"marketing_category": "ANDA",
"nonproprietary_name": "RAMELTEON",
"start_marketing_date": "20230710",
"active_numerator_strength": "8"
}Related drugs
Other records sharing ATC code N05CH02.
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