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United States · US · US:76329-3399_f3adde99-01db-4dee-a59d-9434cbb88495
Procainamide Hydrochloride
Orange BookUNIISPLATC C01BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerInternational Medication Systems, Limited
CountryUS (United States)
ATC codeC01BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1176329339955 SYRINGE in 1 PACKAGE (76329-3399-5) / 10 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
SI4064O0LX
PROCAINAMIDE HYDROCHLORIDE
RxCUI 155056
Orange Book
A088636
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "SI4064O0LX",
"rxcui": "155056",
"inchikey": "ABTXGJFUQRCPNH-UHFFFAOYSA-N",
"display_name": "PROCAINAMIDE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS",
"spl_meta": {
"17e47845-daad-434c-a784-6d3875b0d704": {
"match": "brand_token",
"title": "PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]",
"spl_version": "25",
"published_date": "2026-02-11"
}
},
"productid": "76329-3399_f3adde99-01db-4dee-a59d-9434cbb88495",
"productndc": "76329-3399",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "088636",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "100MG/ML",
"product_no": "001",
"approval_date": "Jul 31, 1984"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PROCAINAMIDE HYDROCHLORIDE",
"proprietary_name": "Procainamide Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA088636",
"marketing_category": "ANDA",
"nonproprietary_name": "Procainamide Hydrochloride",
"start_marketing_date": "20161221",
"active_numerator_strength": "100"
}Related drugs
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