🇺🇸
United States · US · US:70069-691_e1880316-9556-4529-8ba1-8669113a993e
Zinc sulfate
Orange BookSPLATC A12CB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSomerset Therapeutics, LLC
CountryUS (United States)
ATC codeA12CB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11700696912525 VIAL in 1 CARTON (70069-691-25) / 5 mL in 1 VIAL (70069-691-01)
Annotations
Orange Book
A216135
APAP
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": "70069-691_e1880316-9556-4529-8ba1-8669113a993e",
"productndc": "70069-691",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "216135",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 25MG BASE/5ML (EQ 5MG BASE/ML)",
"product_no": "001",
"approval_date": "Jul 17, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 30MG BASE/10ML (EQ 3MG BASE/ML)",
"product_no": "002",
"approval_date": "Jul 17, 2024"
}
],
"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": "ANDA216135",
"marketing_category": "ANDA",
"nonproprietary_name": "Zinc sulfate",
"start_marketing_date": "20240718",
"active_numerator_strength": "5"
}Related drugs
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