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United States · US · US:68382-122_cd7a7360-2639-480a-af3d-0cb410c22110
Amlodipine Besylate
In shortageOrange BookUNIISPLATC C08CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeC08CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116838212201100 TABLET in 1 BOTTLE (68382-122-01)
- ndc116838212205500 TABLET in 1 BOTTLE (68382-122-05)
- ndc11683821221690 TABLET in 1 BOTTLE (68382-122-16)
- ndc11683821227710 BLISTER PACK in 1 CARTON (68382-122-77) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A078226
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": "68382-122_cd7a7360-2639-480a-af3d-0cb410c22110",
"productndc": "68382-122",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078226",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 2.5MG BASE",
"product_no": "001",
"approval_date": "Jul 9, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "002",
"approval_date": "Jul 9, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "003",
"approval_date": "Jul 9, 2007"
}
],
"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": "ANDA078226",
"marketing_category": "ANDA",
"nonproprietary_name": "Amlodipine Besylate",
"start_marketing_date": "20070921",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C08CA01.
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