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United States · US · US:57844-215_78cdd870-2e9f-4ee5-b656-f665a71040a0
GALZIN
Orange BookUNIISPLATC A16AX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeA16AX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115784421552250 CAPSULE in 1 BOTTLE (57844-215-52)
Annotations
UNII (FDA Substance ID)
FM5526K07A
ZINC ACETATE
RxCUI 58295
Orange Book
N020458
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "FM5526K07A",
"rxcui": "58295",
"inchikey": "BEAZKUGSCHFXIQ-UHFFFAOYSA-L",
"display_name": "ZINC ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"2c4fb943-4b2f-273d-e063-6394a90abb47": {
"match": "brand_token",
"title": "GALZIN (ZINC ACETATE) CAPSULE, GELATIN COATED [ETON PHARMACEUTICALS, INC.]",
"spl_version": "5",
"published_date": "2025-11-17"
}
},
"productid": "57844-215_78cdd870-2e9f-4ee5-b656-f665a71040a0",
"productndc": "57844-215",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "020458",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 25MG ZINC",
"product_no": "001",
"approval_date": "Jan 28, 1997"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 50MG ZINC",
"product_no": "002",
"approval_date": "Jan 28, 1997"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZINC ACETATE",
"proprietary_name": "GALZIN",
"active_ingred_unit": "mg/1",
"application_number": "NDA020458",
"marketing_category": "NDA",
"nonproprietary_name": "Zinc Acetate",
"start_marketing_date": "19970303",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code A16AX05.
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