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United States · US · US:0904-7381_94b11ef8-b9c5-491f-a6ff-a3ec9e175ca0
Prochlorperazine Maleate
Orange BookUNIISPLATC N05AB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeN05AB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11090473810650 BLISTER PACK in 1 CARTON (0904-7381-06) / 1 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
I1T8O1JTL6
PROCHLORPERAZINE MALEATE
RxCUI 8706
Orange Book
A216202
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": "0904-7381_94b11ef8-b9c5-491f-a6ff-a3ec9e175ca0",
"productndc": "0904-7381",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216202",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "001",
"approval_date": "Jun 13, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "002",
"approval_date": "Jun 13, 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": "ANDA216202",
"marketing_category": "ANDA",
"nonproprietary_name": "Prochlorperazine Maleate",
"start_marketing_date": "20220801",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N05AB04.
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