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United States · US · US:59762-2242_4826ff96-be7a-460d-8ec0-d6bd025d1162
amlodipine besylate
In shortageOrange BookUNIISPLATC C08CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC08CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115976222423300 TABLET in 1 BOTTLE (59762-2242-3)
- ndc11597622242990 TABLET in 1 BOTTLE (59762-2242-9)
Annotations
UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
N019787
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": "59762-2242_4826ff96-be7a-460d-8ec0-d6bd025d1162",
"productndc": "59762-2242",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "019787",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "Jul 31, 1992"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "Jul 31, 1992"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "003",
"approval_date": "Jul 31, 1992"
}
],
"appl_type": "N"
},
"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": "NDA019787",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "amlodipine besylate",
"start_marketing_date": "20190624",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code C08CA01.
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