Zinc Sulfate

Orange BookSPLATC A12CB01

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

Identification

ManufacturerAmerican Regent, Inc.

CountryUS (United States)

ATC codeA12CB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0517610325
25 VIAL in 1 TRAY (0517-6103-25) / 10 mL in 1 VIAL (0517-6103-01)

Annotations

Orange Book

N209377

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": "0517-6103_daf09709-3280-43f1-9db6-e5dbad4c060b",
  "productndc": "0517-6103",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "209377",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 30MG BASE/10ML (EQ 3MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Jul 18, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 25MG BASE/5ML (EQ 5MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Jul 18, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 10MG BASE/10ML (EQ 1MG BASE/ML)",
        "product_no": "003",
        "approval_date": "Apr 15, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZINC SULFATE",
  "proprietary_name": "Zinc Sulfate",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA209377",
  "marketing_category": "NDA",
  "nonproprietary_name": "Zinc Sulfate",
  "start_marketing_date": "20191001",
  "active_numerator_strength": "3"
}

Related drugs

Other records sharing ATC code A12CB01.

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