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United States · US · US:13517-100_11c83c92-145b-486a-90f3-d759c358d091

Diazoxide

Orange BookUNIISPLATC V03AH01

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

Identification

Manufacturere5 Pharma, LLC
CountryUS (United States)
ATC codeV03AH01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1351710030
    1 BOTTLE, DROPPER in 1 CARTON (13517-100-30) / 30 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
O5CB12L4FN
DIAZOXIDE
RxCUI 3327
Orange Book
A211050
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "O5CB12L4FN",
    "rxcui": "3327",
    "inchikey": "GDLBFKVLRPITMI-UHFFFAOYSA-N",
    "display_name": "DIAZOXIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "abe317a5-6c63-469c-89c8-9fedfe859c3d": {
      "match": "brand_token",
      "title": "DIAZOXIDE SUSPENSION [PAR HEALTH USA, LLC]",
      "spl_version": "7",
      "published_date": "2025-12-31"
    }
  },
  "productid": "13517-100_11c83c92-145b-486a-90f3-d759c358d091",
  "productndc": "13517-100",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "211050",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG/ML",
        "product_no": "001",
        "approval_date": "Dec 20, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIAZOXIDE",
  "proprietary_name": "Diazoxide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA211050",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diazoxide",
  "start_marketing_date": "20191211",
  "active_numerator_strength": "50"
}

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