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United States · US · US:70954-853_5ba22dee-c635-4572-8041-6c25d7c5e22d
Pimozide
Orange BookUNIISPLATC N05AG02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN05AG02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117095485310100 TABLET in 1 BOTTLE (70954-853-10)
Annotations
UNII (FDA Substance ID)
1HIZ4DL86F
PIMOZIDE
RxCUI 8331
Orange Book
A219897
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1HIZ4DL86F",
"rxcui": "8331",
"inchikey": "YVUQSNJEYSNKRX-UHFFFAOYSA-N",
"display_name": "PIMOZIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4e954fc2-fdff-486c-beb6-2b8ace717081": {
"match": "brand_token",
"title": "PIMOZIDE TABLET [ANI PHARMACEUTICALS, INC.]",
"spl_version": "2",
"published_date": "2026-05-21"
}
},
"productid": "70954-853_5ba22dee-c635-4572-8041-6c25d7c5e22d",
"productndc": "70954-853",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "219897",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "001",
"approval_date": "Apr 13, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "002",
"approval_date": "Apr 13, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PIMOZIDE",
"proprietary_name": "Pimozide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA219897",
"marketing_category": "ANDA",
"nonproprietary_name": "Pimozide",
"start_marketing_date": "20260421",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code N05AG02.
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