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United States · US · US:71205-596_fd81606e-c64c-4e10-ab12-39be9a7916e5
Amlodipine Besylate
In shortageOrange BookUNIISPLATC C08CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeC08CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11712055963030 TABLET in 1 BOTTLE (71205-596-30)
- ndc11712055966060 TABLET in 1 BOTTLE (71205-596-60)
- ndc11712055969090 TABLET in 1 BOTTLE (71205-596-90)
Annotations
UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A078925
ABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Amlodipine Besylate; Benazepril Hydrochloride Capsule
Raw payload (JSON)
{
"unii": {
"unii": "864V2Q084H",
"rxcui": "104416",
"inchikey": "ZPBWCRDSRKPIDG-UHFFFAOYSA-N",
"display_name": "AMLODIPINE BESYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6efc0ef6-0424-44fc-a9ea-eb30c3b83239": {
"match": "brand_token",
"title": "AMLODIPINE BESYLATE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]",
"spl_version": "1",
"published_date": "2026-06-01"
}
},
"productid": "71205-596_fd81606e-c64c-4e10-ab12-39be9a7916e5",
"productndc": "71205-596",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078925",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "May 4, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "May 4, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "003",
"approval_date": "May 4, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMLODIPINE BESYLATE",
"shortage_reason": "Amlodipine Besylate; Benazepril Hydrochloride Capsule",
"shortage_status": "current",
"proprietary_name": "Amlodipine Besylate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078925",
"marketing_category": "ANDA",
"nonproprietary_name": "Amlodipine besylate",
"start_marketing_date": "20101020",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C08CA01.
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