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United States · US · US:33342-285_1ea4f227-b97a-49f1-bbc3-1dede2c1866d
amlodipine,valsartan 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 · 3
- ndc11333422850730 TABLET, FILM COATED in 1 BOTTLE (33342-285-07)
- ndc11333422851090 TABLET, FILM COATED in 1 BOTTLE (33342-285-10)
- ndc11333422851210 BLISTER PACK in 1 CARTON (33342-285-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A207299
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": {
"1ea4f227-b97a-49f1-bbc3-1dede2c1866d": {
"match": "brand_token",
"title": "AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]",
"spl_version": "1",
"published_date": "2025-01-13"
}
},
"productid": "33342-285_1ea4f227-b97a-49f1-bbc3-1dede2c1866d",
"productndc": "33342-285",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "207299",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE;12.5MG;160MG",
"product_no": "001",
"approval_date": "Jan 7, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE;25MG;160MG",
"product_no": "002",
"approval_date": "Jan 7, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE;12.5MG;160MG",
"product_no": "003",
"approval_date": "Jan 7, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE;25MG;160MG",
"product_no": "004",
"approval_date": "Jan 7, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE;25MG;320MG",
"product_no": "005",
"approval_date": "Jan 7, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
"shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
"shortage_status": "current",
"proprietary_name": "amlodipine,valsartan and hydrochlorothiazide",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "ANDA207299",
"marketing_category": "ANDA",
"nonproprietary_name": "amlodipine,valsartan and hydrochlorothiazide",
"start_marketing_date": "20250106",
"active_numerator_strength": "5; 25; 160"
}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
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