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United States · US · US:46708-212_cbb564d2-add9-430a-a36b-45147d417138
Amlodipine besylate and Olmesartran medoxomil
In shortageOrange BookUNIISPLATC C08CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeC08CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11467082123030 TABLET, FILM COATED in 1 BOTTLE (46708-212-30)
- ndc11467082129090 TABLET, FILM COATED in 1 BOTTLE (46708-212-90)
- ndc1146708212911000 TABLET, FILM COATED in 1 BOTTLE (46708-212-91)
Annotations
UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A207073
ABABABAB
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": "46708-212_cbb564d2-add9-430a-a36b-45147d417138",
"productndc": "46708-212",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "207073",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE;20MG",
"product_no": "001",
"approval_date": "Jul 17, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE;40MG",
"product_no": "002",
"approval_date": "Jul 17, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE;20MG",
"product_no": "003",
"approval_date": "Jul 17, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE;40MG",
"product_no": "004",
"approval_date": "Jul 17, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
"shortage_reason": "Amlodipine Besylate; Benazepril Hydrochloride Capsule",
"shortage_status": "current",
"proprietary_name": "Amlodipine besylate and Olmesartran medoxomil",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA207073",
"marketing_category": "ANDA",
"nonproprietary_name": "Amlodipine besylate and Olmesartran medoxomil",
"start_marketing_date": "20170718",
"active_numerator_strength": "5; 20"
}Related drugs
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- GBAmlodipine 5mg / Valsartan 160mg tabletsZentiva Pharma UK Ltd
- GBAmlodipine 5mg / Valsartan 160mg tabletsA A H Pharmaceuticals Ltd
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