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United States · US · US:82449-004_3eebc107-3b95-1b1e-e063-6394a90afed2
Ziprasidone Mesylate
Orange BookUNIISPLATC N05AE04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSTERISCIENCE SPECIALTIES PRIVATE LIMITED
CountryUS (United States)
ATC codeN05AE04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1182449004011 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-01) / 1 mL in 1 VIAL, SINGLE-DOSE
- ndc11824490040210 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-02) / 1 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
3X6SAX83JZ
ZIPRASIDONE MESYLATE
RxCUI 353116
Orange Book
A217595
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "3X6SAX83JZ",
"rxcui": "353116",
"inchikey": "WLQZEFFFIUHSJB-UHFFFAOYSA-N",
"display_name": "ZIPRASIDONE MESYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR",
"spl_meta": {
"7e7261d7-4902-4bb5-a268-6c358890f963": {
"match": "brand_token",
"title": "ZIPRASIDONE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]",
"spl_version": "18",
"published_date": "2026-05-25"
}
},
"productid": "82449-004_3eebc107-3b95-1b1e-e063-6394a90afed2",
"productndc": "82449-004",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "217595",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 20MG BASE/VIAL",
"product_no": "001",
"approval_date": "Sep 3, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZIPRASIDONE MESYLATE",
"proprietary_name": "Ziprasidone Mesylate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA217595",
"marketing_category": "ANDA",
"nonproprietary_name": "ziprasidone mesylate",
"start_marketing_date": "20251219",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N05AE04.
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