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United States · US · US:70710-1667_da187256-50af-400b-ab27-a073f3fbe81a
Prochlorperazine Maleate
Orange BookUNIISPLATC N05AB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals (USA) Inc.
CountryUS (United States)
ATC codeN05AB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117071016671100 TABLET in 1 BOTTLE (70710-1667-1)
Annotations
UNII (FDA Substance ID)
I1T8O1JTL6
PROCHLORPERAZINE MALEATE
RxCUI 8706
Orange Book
A216495
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "I1T8O1JTL6",
"rxcui": "8706",
"inchikey": "DSKIOWHQLUWFLG-SPIKMXEPSA-N",
"display_name": "PROCHLORPERAZINE MALEATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d6fc83ad-9cce-4e60-854c-3825313ee60c": {
"match": "brand_token",
"title": "PROCHLORPERAZINE MALEATE TABLET [MAJOR PHARMACEUTICALS]",
"spl_version": "4",
"published_date": "2026-05-21"
}
},
"productid": "70710-1667_da187256-50af-400b-ab27-a073f3fbe81a",
"productndc": "70710-1667",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216495",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "001",
"approval_date": "Aug 8, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "002",
"approval_date": "Aug 8, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PROCHLORPERAZINE MALEATE",
"proprietary_name": "Prochlorperazine Maleate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216495",
"marketing_category": "ANDA",
"nonproprietary_name": "Prochlorperazine Maleate",
"start_marketing_date": "20220810",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N05AB04.
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