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United States · US · US:69452-206_4527bd89-c3ee-9cfe-e063-6294a90a3ebc

Doxylamine succinate and Pyridoxine hydrochloride

In shortageOrange BookUNIISPLATC R06AA

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

Identification

ManufacturerBionpharma Inc.,
CountryUS (United States)
ATC codeR06AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6945220620
    100 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-206-20)

Annotations

UNII (FDA Substance ID)
V9BI9B5YI2
DOXYLAMINE SUCCINATE
RxCUI 23665
Orange Book
A217000
AB
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": {
    "0c410285-0ad6-aabc-e063-6294a90abcd8": {
      "match": "brand_token",
      "title": "DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE TABLET, DELAYED RELEASE [BIONPHARMA INC.,]",
      "spl_version": "2",
      "published_date": "2025-12-05"
    }
  },
  "productid": "69452-206_4527bd89-c3ee-9cfe-e063-6294a90a3ebc",
  "productndc": "69452-206",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "217000",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;10MG",
        "product_no": "001",
        "approval_date": "Aug 4, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
  "shortage_reason": "Doxylamine Succinate and Pyridoxine  Hydrochloride Tablet, Delayed Release",
  "shortage_status": "current",
  "proprietary_name": "Doxylamine succinate and Pyridoxine hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA217000",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxylamine succinate and Pyridoxine hydrochloride",
  "start_marketing_date": "20231211",
  "active_numerator_strength": "10; 10"
}

Related drugs

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