🇺🇸
United States · US · US:68083-604_e8e25e4b-14ce-40cb-85d9-4cc78ca9e807
Procainamide Hydrochloride
Orange BookUNIISPLATC C01BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeC01BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680836042525 VIAL, MULTI-DOSE in 1 CASE (68083-604-25) / 2 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
SI4064O0LX
PROCAINAMIDE HYDROCHLORIDE
RxCUI 155056
Orange Book
A218135
APAP
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": "68083-604_e8e25e4b-14ce-40cb-85d9-4cc78ca9e807",
"productndc": "68083-604",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "218135",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "100MG/ML",
"product_no": "001",
"approval_date": "Jul 22, 2024"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "500MG/ML",
"product_no": "002",
"approval_date": "Jul 22, 2024"
}
],
"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": "ANDA218135",
"marketing_category": "ANDA",
"nonproprietary_name": "Procainamide Hydrochloride",
"start_marketing_date": "20240722",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code C01BA02.
- FICardiorytminSchering Oy
- FICardiorytminSchering Oy
- FICardiorytmin RetardSchering Oy
- GBProcainamide 250mg capsulesSpecial Order
- 🇺🇸PROCAINAMIDE HCIHF Acquisition Co LLC, DBA HealthFirst
- 🇺🇸Procainamide HydrochlorideCaplin Steriles Limited
- 🇺🇸Procainamide HydrochlorideInternational Medication Systems, Limited
- 🇺🇸Procainamide HydrochlorideMedical Purchasing Solutions, LLC
Access this data programmatically
Query Procainamide Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.