Zinc Sulfate

Orange BookUNIISPLATC A12CB01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerApotex Corp

CountryUS (United States)

ATC codeA12CB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6050562605
25 VIAL in 1 CARTON (60505-6260-5) / 5 mL in 1 VIAL (60505-6260-0)

Annotations

UNII (FDA Substance ID)

89DS0H96TB

ZINC SULFATE, UNSPECIFIED FORM

RxCUI 39954

Orange Book

A218059

APAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "89DS0H96TB",
    "rxcui": "39954",
    "inchikey": null,
    "display_name": "ZINC SULFATE, UNSPECIFIED FORM",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "63b551fc-7d16-c099-e053-2a91aa0a5f2c": {
      "match": "brand_token",
      "title": "ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [TRIFECTA PHARMACEUTICALS USA]",
      "spl_version": "7",
      "published_date": "2026-05-20"
    }
  },
  "productid": "60505-6260_c78f555b-3f22-d031-b241-769f29b4c936",
  "productndc": "60505-6260",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "218059",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 25MG BASE/5ML (EQ 5MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Jun 10, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 10MG BASE/10ML (EQ 1MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Oct 28, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZINC SULFATE, UNSPECIFIED FORM",
  "proprietary_name": "Zinc Sulfate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA218059",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Zinc Sulfate Injection",
  "start_marketing_date": "20240801",
  "active_numerator_strength": "5"
}

Related drugs

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