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United States · US · US:50090-7955_427b2bda-da8a-4776-8828-0194901f51ad
Amlodipine Besylate
In shortageOrange BookUNIISPLATC C08CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeC08CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11500907955190 TABLET in 1 BOTTLE (50090-7955-1)
- ndc11500907955230 TABLET in 1 BOTTLE (50090-7955-2)
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; 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": "50090-7955_427b2bda-da8a-4776-8828-0194901f51ad",
"productndc": "50090-7955",
"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; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
"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": "20251206",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code C08CA01.
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