Zinc Sulfate

Orange BookSPLATC A12CB01

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeA12CB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6521940101
25 VIAL in 1 TRAY (65219-401-01) / 10 mL in 1 VIAL (65219-401-00)

Annotations

Orange Book

A216145

APAPAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "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": "65219-401_af258d83-398d-4601-ab09-14c9fe383cc2",
  "productndc": "65219-401",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "216145",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 10MG BASE/10ML (EQ 1MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Dec 27, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 25MG BASE/5ML (EQ 5MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Dec 27, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 30MG BASE/10ML (EQ 3MG BASE/ML)",
        "product_no": "003",
        "approval_date": "Dec 27, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZINC SULFATE",
  "proprietary_name": "Zinc Sulfate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216145",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Zinc Sulfate",
  "start_marketing_date": "20221227",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code A12CB01.

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