Zinc Sulfate

Orange BookSPLATC A12CB01

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

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC codeA12CB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808349925
25 VIAL in 1 CARTON (68083-499-25) / 5 mL in 1 VIAL

Annotations

Orange Book

A216249

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": "68083-499_cfa59996-1de2-4313-a7ac-1766764513e2",
  "productndc": "68083-499",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "216249",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 25MG BASE/5ML (EQ 5MG BASE/ML)",
        "product_no": "001",
        "approval_date": "May 3, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 30MG BASE/10ML (EQ 3MG BASE/ML)",
        "product_no": "002",
        "approval_date": "May 3, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 10MG BASE/10ML (EQ 1MG BASE/ML)",
        "product_no": "003",
        "approval_date": "Sep 1, 2023"
      }
    ],
    "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": "ANDA216249",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Zinc Sulfate",
  "start_marketing_date": "20220503",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code A12CB01.

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