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United States · US · US:0065-0411_45bf2066-cfd2-48ef-acf9-b590c69b83d8

Betadine

Orange BookUNIISPLATC D09AA09

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

Identification

ManufacturerAlcon Laboratories, Inc.
CountryUS (United States)
ATC codeD09AA09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0065041130
    1 BOTTLE in 1 CARTON (0065-0411-30) / 30 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
85H0HZU99M
POVIDONE-IODINE
RxCUI 8611
Orange Book
N018634
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "85H0HZU99M",
    "rxcui": "8611",
    "inchikey": null,
    "display_name": "POVIDONE-IODINE",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "3be9fa6e-3ae8-496b-876b-f81f1cd98af4": {
      "match": "brand_token",
      "title": "BETADINE FOAM CLEANSER (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [ATLANTIS CONSUMER HEALTHCARE, INC.]",
      "spl_version": "1",
      "published_date": "2026-02-02"
    }
  },
  "productid": "0065-0411_45bf2066-cfd2-48ef-acf9-b590c69b83d8",
  "productndc": "0065-0411",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "018634",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Dec 17, 1986"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POVIDONE-IODINE",
  "proprietary_name": "Betadine",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA018634",
  "marketing_category": "NDA",
  "nonproprietary_name": "povidone-iodine",
  "start_marketing_date": "20000401",
  "active_numerator_strength": "5"
}

Related drugs

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