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United States · US · US:24208-317_06ea3d35-67bf-d0b8-e063-6294a90a5b0c

Sulfacetamide Sodium and Prednisolone Sodium Phosphate

Orange BookUNIISPLATC A01AC

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

Identification

ManufacturerBausch & Lomb Incoporated
CountryUS (United States)
ATC codeA01AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2420831705
    1 BOTTLE, DROPPER in 1 CARTON (24208-317-05) / 5 mL in 1 BOTTLE, DROPPER
  • ndc11
    2420831710
    1 BOTTLE, DROPPER in 1 CARTON (24208-317-10) / 10 mL in 1 BOTTLE, DROPPER

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": "24208-317_06ea3d35-67bf-d0b8-e063-6294a90a5b0c",
  "productndc": "24208-317",
  "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"
}

Related drugs

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