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United States · US · US:68462-947_87ee1668-fd00-4e54-8c72-14ca91b94e0e
PROCHLORPERAZINE MALEATE
Orange BookUNIISPLATC N05AB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGLENMARK PHARMACEUTICALS INC., USA
CountryUS (United States)
ATC codeN05AB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116846294701100 TABLET in 1 BOTTLE (68462-947-01)
- ndc1168462947101000 TABLET in 1 BOTTLE (68462-947-10)
Annotations
UNII (FDA Substance ID)
I1T8O1JTL6
PROCHLORPERAZINE MALEATE
RxCUI 8706
Orange Book
A216595
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": "68462-947_87ee1668-fd00-4e54-8c72-14ca91b94e0e",
"productndc": "68462-947",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216595",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "001",
"approval_date": "Mar 17, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "002",
"approval_date": "Mar 17, 2023"
}
],
"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": "ANDA216595",
"marketing_category": "ANDA",
"nonproprietary_name": "PROCHLORPERAZINE MALEATE",
"start_marketing_date": "20250528",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05AB04.
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