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United States · US · US:60219-2039_64f464e7-2297-4543-a96d-bfe9e541930f
prochlorperazine maleate
Orange BookUNIISPLATC N05AB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeN05AB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116021920391100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60219-2039-1)
- ndc1160219203971000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60219-2039-7)
Annotations
UNII (FDA Substance ID)
I1T8O1JTL6
PROCHLORPERAZINE MALEATE
RxCUI 8706
Orange Book
A216598
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": "60219-2039_64f464e7-2297-4543-a96d-bfe9e541930f",
"productndc": "60219-2039",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "216598",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "001",
"approval_date": "Apr 17, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "002",
"approval_date": "Apr 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": "ANDA216598",
"marketing_category": "ANDA",
"nonproprietary_name": "prochlorperazine maleate",
"start_marketing_date": "20230421",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05AB04.
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