Ramelteon

In shortageOrange BookUNIISPLATC N05CH02

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeN05CH02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7120591800
100 TABLET in 1 BOTTLE (71205-918-00)
ndc11
7120591830
30 TABLET in 1 BOTTLE (71205-918-30)
ndc11
7120591855
500 TABLET in 1 BOTTLE (71205-918-55)
ndc11
7120591860
60 TABLET in 1 BOTTLE (71205-918-60)
ndc11
7120591872
120 TABLET in 1 BOTTLE (71205-918-72)
ndc11
7120591890
90 TABLET in 1 BOTTLE (71205-918-90)

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": "71205-918_c90ef143-aff7-41d6-9171-3e5e7bb6e97e",
  "productndc": "71205-918",
  "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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