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United States · US · US:62135-842_22e33608-9604-ec44-e063-6394a90a3d12

sulfADIAZINE

Orange BookUNIISPLATC J01EC02

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

Identification

ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeJ01EC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6213584260
    60 TABLET in 1 BOTTLE (62135-842-60)

Annotations

UNII (FDA Substance ID)
0N7609K889
SULFADIAZINE
RxCUI 10171
Orange Book
A080084
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0N7609K889",
    "rxcui": "10171",
    "inchikey": "SEEPANYCNGTZFQ-UHFFFAOYSA-N",
    "display_name": "SULFADIAZINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6e0e9e1b-2ada-35d0-e053-2991aa0a65fb": {
      "match": "brand_token",
      "title": "SULFADIAZINE SODIUM POWDER [NANHAI BEISHA PHARMACEUTICAL CO. LTD]",
      "spl_version": "2",
      "published_date": "2025-08-22"
    }
  },
  "productid": "62135-842_22e33608-9604-ec44-e063-6394a90a3d12",
  "productndc": "62135-842",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "080084",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SULFADIAZINE",
  "proprietary_name": "sulfADIAZINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA080084",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sulfADIAZINE",
  "start_marketing_date": "20240923",
  "active_numerator_strength": "500"
}

Related drugs

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