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United States · US · US:0187-5198_4dd0038b-2f5d-436c-8a6d-6db44760c37a

Klaron

Orange BookUNIIATC S01AB04

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

Identification

ManufacturerBausch Health US, LLC
CountryUS (United States)
ATC codeS01AB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0187519804
    1 BOTTLE, PLASTIC in 1 CARTON (0187-5198-04) / 118 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
4NRT660KJQ
SULFACETAMIDE SODIUM
RxCUI 82101
Orange Book
N019931
AB
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",
  "productid": "0187-5198_4dd0038b-2f5d-436c-8a6d-6db44760c37a",
  "productndc": "0187-5198",
  "dosage_form": "LOTION",
  "orange_book": {
    "appl_no": "019931",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10%",
        "product_no": "001",
        "approval_date": "Dec 23, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SULFACETAMIDE SODIUM",
  "proprietary_name": "Klaron",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019931",
  "marketing_category": "NDA",
  "nonproprietary_name": "sulfacetamide sodium",
  "start_marketing_date": "19961223",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code S01AB04.

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