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United States · US · US:68071-1650_1d4de4f7-e86f-d269-e063-6294a90ab688

Sulfacetamide Sodium and Prednisolone Sodium Phosphate

Orange BookUNIISPLATC A01AC

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

Identification

ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeA01AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6807116505
    5 mL in 1 BOX (68071-1650-5)

Annotations

UNII (FDA Substance ID)
IV021NXA9J
PREDNISOLONE SODIUM PHOSPHATE
RxCUI 55062
Orange Book
A074449
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "IV021NXA9J",
    "rxcui": "55062",
    "inchikey": "VJZLQIPZNBPASX-OJJGEMKLSA-L",
    "display_name": "PREDNISOLONE SODIUM PHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "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": "68071-1650_1d4de4f7-e86f-d269-e063-6294a90ab688",
  "productndc": "68071-1650",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "074449",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.23% PHOSPHATE;10%",
        "product_no": "001",
        "approval_date": "Dec 29, 1995"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM",
  "proprietary_name": "Sulfacetamide Sodium and Prednisolone Sodium Phosphate",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA074449",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sulfacetamide Sodium and Prednisolone Sodium Phosphate",
  "start_marketing_date": "19951229",
  "active_numerator_strength": "2.3; 100"
}

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