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United States · US · US:70010-028_019388a3-ecda-7396-e063-6294a90a62b6
Ramelteon
In shortageOrange BookUNIISPLATC N05CH02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGranules Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN05CH02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117001002801100 TABLET in 1 BOTTLE (70010-028-01)
- ndc11700100280330 TABLET in 1 BOTTLE (70010-028-03)
- ndc117001002805500 TABLET in 1 BOTTLE (70010-028-05)
Annotations
UNII (FDA Substance ID)
901AS54I69
RAMELTEON
RxCUI 596205
Orange Book
A213186
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": "70010-028_019388a3-ecda-7396-e063-6294a90a62b6",
"productndc": "70010-028",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213186",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "8MG",
"product_no": "001",
"approval_date": "Aug 21, 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": "ANDA213186",
"marketing_category": "ANDA",
"nonproprietary_name": "Ramelteon",
"start_marketing_date": "20201001",
"active_numerator_strength": "8"
}Related drugs
Other records sharing ATC code N05CH02.
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