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United States · US · US:33342-245_52c013e1-8c31-4bed-9241-e7845873ebe8
Olmesartan medoxomil Amlodipine and Hydrochlorothiazide
In shortageOrange BookUNIISPLATC C08CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeC08CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11333422450730 TABLET, FILM COATED in 1 BOTTLE (33342-245-07)
- ndc11333422451090 TABLET, FILM COATED in 1 BOTTLE (33342-245-10)
Annotations
UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A207088
ABABABABAB
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": {
"7f78d14a-acf2-4f82-9d20-dfcbd5e9ffb3": {
"match": "brand_token",
"title": "OLMESARTAN MEDOXOMIL TABLET [A-S MEDICATION SOLUTIONS]",
"spl_version": "1",
"published_date": "2026-06-01"
}
},
"productid": "33342-245_52c013e1-8c31-4bed-9241-e7845873ebe8",
"productndc": "33342-245",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "207088",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE;12.5MG;20MG",
"product_no": "001",
"approval_date": "Jul 18, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE;12.5MG;40MG",
"product_no": "002",
"approval_date": "Jul 18, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE;25MG;40MG",
"product_no": "003",
"approval_date": "Jul 18, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE;12.5MG;40MG",
"product_no": "004",
"approval_date": "Jul 18, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE;25MG;40MG",
"product_no": "005",
"approval_date": "Jul 18, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
"shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
"shortage_status": "current",
"proprietary_name": "Olmesartan medoxomil Amlodipine and Hydrochlorothiazide",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "ANDA207088",
"marketing_category": "ANDA",
"nonproprietary_name": "Olmesartan medoxomil Amlodipine and Hydrochlorothiazide",
"start_marketing_date": "20250718",
"active_numerator_strength": "5; 25; 40"
}Related drugs
Other records sharing ATC code C08CA.
- GBAmlodipine 10mg / Valsartan 160mg tabletsZentiva Pharma UK Ltd
- GBAmlodipine 10mg / Valsartan 160mg tabletsAlliance Healthcare (Distribution) Ltd
- GBAmlodipine 10mg / Valsartan 160mg tabletsA A H Pharmaceuticals Ltd
- GBAmlodipine 5mg / Valsartan 160mg tabletsAlliance Healthcare (Distribution) Ltd
- GBAmlodipine 5mg / Valsartan 160mg tabletsZentiva Pharma UK Ltd
- GBAmlodipine 5mg / Valsartan 160mg tabletsA A H Pharmaceuticals Ltd
- GBAmlodipine 5mg / Valsartan 80mg tabletsA A H Pharmaceuticals Ltd
- GBAmlodipine 5mg / Valsartan 80mg tabletsAlliance Healthcare (Distribution) Ltd
Access this data programmatically
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