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United States · US · US:69584-021_afdff9c9-5e2d-44e7-b5ea-a4d8836ddf05
AMLODIPINE BESYLATE
In shortageOrange BookUNIISPLATC C08CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOxford Pharmaceuticals, LLC
CountryUS (United States)
ATC codeC08CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11695840210990 TABLET in 1 BOTTLE (69584-021-09)
- ndc116958402150500 TABLET in 1 BOTTLE (69584-021-50)
- ndc1169584021901000 TABLET in 1 BOTTLE (69584-021-90)
Annotations
UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A078414
ABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet
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": "69584-021_afdff9c9-5e2d-44e7-b5ea-a4d8836ddf05",
"productndc": "69584-021",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078414",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "Apr 7, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "Apr 7, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "003",
"approval_date": "Apr 7, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMLODIPINE BESYLATE",
"shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
"shortage_status": "current",
"proprietary_name": "AMLODIPINE BESYLATE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078414",
"marketing_category": "ANDA",
"nonproprietary_name": "AMLODIPINE BESYLATE",
"start_marketing_date": "20211001",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code C08CA01.
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