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United States · US · US:76420-628_0b2fcb56-d9fa-e9f6-e063-6294a90a2f8e
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
- ndc117642062801100 TABLET in 1 BOTTLE (76420-628-01)
- ndc11764206283030 TABLET in 1 BOTTLE (76420-628-30)
- ndc11764206286060 TABLET in 1 BOTTLE (76420-628-60)
- ndc11764206289090 TABLET in 1 BOTTLE (76420-628-90)
Annotations
UNII (FDA Substance ID)
901AS54I69
RAMELTEON
RxCUI 596205
Orange Book
A211567
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": "76420-628_0b2fcb56-d9fa-e9f6-e063-6294a90a2f8e",
"productndc": "76420-628",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211567",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "8MG",
"product_no": "001",
"approval_date": "Jul 22, 2019"
}
],
"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": "ANDA211567",
"marketing_category": "ANDA",
"nonproprietary_name": "Ramelteon",
"start_marketing_date": "20190723",
"active_numerator_strength": "8"
}Related drugs
Other records sharing ATC code N05CH02.
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