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United States · US · US:27854-375_200f8580-e4b0-4d64-b4c0-615b47e688cd

Nocto Sleep Aid

In shortageOrange BookUNIISPLATC R06AA59

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBelmora LLC
CountryUS (United States)
ATC codeR06AA59
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2785437501
    1 BOTTLE, PLASTIC in 1 CARTON (27854-375-01) / 24 TABLET in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
V9BI9B5YI2
DOXYLAMINE SUCCINATE
RxCUI 23665
Orange Book
A040564
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Doxylamine Succinate and Pyridoxine Hydrochloride Tablet, Delayed Release
Raw payload (JSON)
{
  "unii": {
    "unii": "V9BI9B5YI2",
    "rxcui": "23665",
    "inchikey": "KBAUFVUYFNWQFM-UHFFFAOYSA-N",
    "display_name": "DOXYLAMINE SUCCINATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d255309b-0023-48fe-890f-6a4fe04dbb85": {
      "match": "brand_token",
      "title": "NOCTO SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [BELMORA LLC]",
      "spl_version": "8",
      "published_date": "2025-07-21"
    }
  },
  "productid": "27854-375_200f8580-e4b0-4d64-b4c0-615b47e688cd",
  "productndc": "27854-375",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040564",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Aug 27, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DOXYLAMINE SUCCINATE",
  "shortage_reason": "Doxylamine Succinate and Pyridoxine  Hydrochloride Tablet, Delayed Release",
  "shortage_status": "current",
  "proprietary_name": "Nocto Sleep Aid",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040564",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxylamine succinate",
  "start_marketing_date": "20191031",
  "active_numerator_strength": "25"
}

Related drugs

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