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United States · US · US:65145-119_5b239257-b476-4705-b408-bcf1d0003305
Prochlorperazine Edisylate
Orange BookUNIISPLATC N05AB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCaplin Steriles Limited
CountryUS (United States)
ATC codeN05AB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11651451191010 VIAL in 1 CARTON (65145-119-10) / 2 mL in 1 VIAL (65145-119-01)
Annotations
UNII (FDA Substance ID)
PG20W5VQZS
PROCHLORPERAZINE EDISYLATE
RxCUI 8705
Orange Book
A214379
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "PG20W5VQZS",
"rxcui": "8705",
"inchikey": "SWOUGRBFXFILIB-UHFFFAOYSA-N",
"display_name": "PROCHLORPERAZINE EDISYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS",
"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": "65145-119_5b239257-b476-4705-b408-bcf1d0003305",
"productndc": "65145-119",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "214379",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 5MG BASE/ML",
"product_no": "001",
"approval_date": "Apr 22, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PROCHLORPERAZINE EDISYLATE",
"proprietary_name": "Prochlorperazine Edisylate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA214379",
"marketing_category": "ANDA",
"nonproprietary_name": "Prochlorperazine Edisylate",
"start_marketing_date": "20260408",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N05AB04.
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