Ramelteon

In shortageOrange BookUNIISPLATC N05CH02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerASCLEMED USA INC.

CountryUS (United States)

ATC codeN05CH02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
8706318901
100 TABLET in 1 BOTTLE (87063-189-01)
ndc11
8706318905
5 TABLET in 1 BOTTLE (87063-189-05)
ndc11
8706318910
10 TABLET in 1 BOTTLE (87063-189-10)
ndc11
8706318920
20 TABLET in 1 BOTTLE (87063-189-20)
ndc11
8706318930
30 TABLET in 1 BOTTLE (87063-189-30)
ndc11
8706318960
60 TABLET in 1 BOTTLE (87063-189-60)
ndc11
8706318990
90 TABLET in 1 BOTTLE (87063-189-90)

Annotations

UNII (FDA Substance ID)

901AS54I69

RAMELTEON

RxCUI 596205

Orange Book

A215243

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": "87063-189_51354e62-ab19-97a2-e063-6294a90ab08b",
  "productndc": "87063-189",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "215243",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "001",
        "approval_date": "Feb 9, 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": "ANDA215243",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ramelteon",
  "start_marketing_date": "20230501",
  "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.

Get a free API key Read the API docs