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United States · US · US:62332-966_440a5eea-c5f5-4e61-e063-6294a90a3a0c
PIVYA
Orange BookUNIISPLATC J01CA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ01CA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1162332966091 BLISTER PACK in 1 CARTON (62332-966-09) / 9 TABLET, COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
48FX7N21H2
PIVMECILLINAM HYDROCHLORIDE
RxCUI 102745
Orange Book
N216483
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "48FX7N21H2",
"rxcui": "102745",
"inchikey": "UHPXMYLONAGUPC-WKLLBTDKSA-N",
"display_name": "PIVMECILLINAM HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"440a5f17-ab11-0fc8-e063-6394a90a58e9": {
"match": "brand_token",
"title": "PIVYA (PIVMECILLINAM) TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]",
"spl_version": "1",
"published_date": "2026-02-02"
}
},
"productid": "62332-966_440a5eea-c5f5-4e61-e063-6294a90a3a0c",
"productndc": "62332-966",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "216483",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 185MG BASE",
"product_no": "001",
"approval_date": "Apr 24, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PIVMECILLINAM HYDROCHLORIDE",
"proprietary_name": "PIVYA",
"active_ingred_unit": "mg/1",
"application_number": "NDA216483",
"marketing_category": "NDA",
"nonproprietary_name": "Pivmecillinam",
"start_marketing_date": "20260202",
"active_numerator_strength": "185"
}Related drugs
Other records sharing ATC code J01CA08.
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