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United States · US · US:69097-127_7cbe66f6-99fb-403f-9c6b-e4ecc7549eaf
AMLODIPINE BESYLATE
In shortageOrange BookUNIISPLATC C08CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeC08CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11690971270590 TABLET in 1 BOTTLE (69097-127-05)
- ndc1169097127151000 TABLET in 1 BOTTLE (69097-127-15)
Annotations
UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A077073
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": "69097-127_7cbe66f6-99fb-403f-9c6b-e4ecc7549eaf",
"productndc": "69097-127",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077073",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "Sep 26, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "Sep 26, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "003",
"approval_date": "Sep 26, 2007"
}
],
"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": "ANDA077073",
"marketing_category": "ANDA",
"nonproprietary_name": "AMLODIPINE BESYLATE",
"start_marketing_date": "20070926",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C08CA01.
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