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United States · US · US:49035-968_923a648d-7b97-454f-99f0-ba3c4af71b6f

Sleep Aid

In shortageOrange BookUNIISPLATC R06AA59

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

Identification

ManufacturerWal-Mart Stores Inc
CountryUS (United States)
ATC codeR06AA59
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4903596827
    32 TABLET in 1 BOTTLE, PLASTIC (49035-968-27)

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": {
    "4b5fdb06-f205-4424-b4cb-dddef921485b": {
      "match": "brand_token",
      "title": "SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [RITE AID CORPORATION]",
      "spl_version": "4",
      "published_date": "2026-05-28"
    }
  },
  "productid": "49035-968_923a648d-7b97-454f-99f0-ba3c4af71b6f",
  "productndc": "49035-968",
  "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": "Sleep Aid",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040564",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxylamine Succinate",
  "start_marketing_date": "20190715",
  "active_numerator_strength": "25"
}

Related drugs

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