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United States · US · US:80425-0343_2a9bf7d3-46de-0dfa-e063-6394a90a76a4
Ramelteon
In shortageOrange BookUNIISPLATC N05CH02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeN05CH02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11804250343130 TABLET, FILM COATED in 1 BOTTLE (80425-0343-1)
Annotations
UNII (FDA Substance ID)
901AS54I69
RAMELTEON
RxCUI 596205
Orange Book
A213815
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": "80425-0343_2a9bf7d3-46de-0dfa-e063-6394a90a76a4",
"productndc": "80425-0343",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213815",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "8MG",
"product_no": "001",
"approval_date": "Oct 26, 2020"
}
],
"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": "ANDA213815",
"marketing_category": "ANDA",
"nonproprietary_name": "Ramelteon",
"start_marketing_date": "20230615",
"active_numerator_strength": "8"
}Related drugs
Other records sharing ATC code N05CH02.
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