🇺🇸
United States · US · US:82804-216_2cb1b48a-05c0-4058-8ccd-1971098b8ce1
Ramelteon
In shortageOrange BookUNIISPLATC N05CH02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN05CH02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11828042163030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-216-30)
Annotations
UNII (FDA Substance ID)
901AS54I69
RAMELTEON
RxCUI 596205
Orange Book
A212650
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": "82804-216_2cb1b48a-05c0-4058-8ccd-1971098b8ce1",
"productndc": "82804-216",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "212650",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "8MG",
"product_no": "001",
"approval_date": "Apr 10, 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": "ANDA212650",
"marketing_category": "ANDA",
"nonproprietary_name": "Ramelteon",
"start_marketing_date": "20200630",
"active_numerator_strength": "8"
}Related drugs
Other records sharing ATC code N05CH02.
Access this data programmatically
Query Ramelteon 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.