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United States · US · US:52652-5001_461e8d10-1805-e107-e063-6294a90aa288
Katerzia
In shortageOrange BookUNIISPLATC C08CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAzurity Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC08CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1152652500111 BOTTLE in 1 CARTON (52652-5001-1) / 150 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
XD75TQ8A2P
AMLODIPINE BENZOATE
RxCUI 2184116
Orange Book
N211340
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Amlodipine Besylate; Benazepril Hydrochloride Capsule
Raw payload (JSON)
{
"unii": {
"unii": "XD75TQ8A2P",
"rxcui": "2184116",
"inchikey": "RVPCEXXEUXIPEO-UHFFFAOYSA-N",
"display_name": "AMLODIPINE BENZOATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"df673a4d-acb8-444c-a472-c87ab8cbd366": {
"match": "brand_token",
"title": "KATERZIA (AMLODIPINE) SUSPENSION [AZURITY PHARMACEUTICALS, INC.]",
"spl_version": "7",
"published_date": "2025-12-18"
}
},
"productid": "52652-5001_461e8d10-1805-e107-e063-6294a90aa288",
"productndc": "52652-5001",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "211340",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 1MG BASE/ML",
"product_no": "001",
"approval_date": "Jul 8, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMLODIPINE BENZOATE",
"shortage_reason": "Amlodipine Besylate; Benazepril Hydrochloride Capsule",
"shortage_status": "current",
"proprietary_name": "Katerzia",
"active_ingred_unit": "mg/mL",
"application_number": "NDA211340",
"marketing_category": "NDA",
"nonproprietary_name": "Amlodipine",
"start_marketing_date": "20190815",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code C08CA01.
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