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United States · US · US:45802-896_03f16a28-7c10-4fa0-a4c8-ac29335c6be7

Sulfacetamide Sodium

Orange BookUNIISPLATC S01AB04

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

Identification

ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeS01AB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4580289626
    118 mL in 1 BOTTLE, PLASTIC (45802-896-26)

Annotations

UNII (FDA Substance ID)
4NRT660KJQ
SULFACETAMIDE SODIUM
RxCUI 82101
Orange Book
A078649
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4NRT660KJQ",
    "rxcui": "82101",
    "inchikey": "IHCDKJZZFOUARO-UHFFFAOYSA-M",
    "display_name": "SULFACETAMIDE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "f212af23-be3d-4e82-9f6f-5ddce12a89da": {
      "match": "brand_token",
      "title": "SULFACETAMIDE SODIUM SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]",
      "spl_version": "14",
      "published_date": "2026-03-24"
    }
  },
  "productid": "45802-896_03f16a28-7c10-4fa0-a4c8-ac29335c6be7",
  "productndc": "45802-896",
  "dosage_form": "LOTION",
  "orange_book": {
    "appl_no": "078649",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10%",
        "product_no": "001",
        "approval_date": "Mar 23, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SULFACETAMIDE SODIUM",
  "proprietary_name": "Sulfacetamide Sodium",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA078649",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sulfacetamide Sodium",
  "start_marketing_date": "20121017",
  "active_numerator_strength": "100"
}

Related drugs

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