🇺🇸
United States · US · US:33342-280_d520c66f-440c-4f7e-b057-0d548c3142e7
amlodipine and valsartan
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
- ndc11333422800730 TABLET in 1 BOTTLE (33342-280-07)
- ndc11333422801090 TABLET in 1 BOTTLE (33342-280-10)
- ndc11333422801210 BLISTER PACK in 1 CARTON (33342-280-12) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A207292
ABABABAB
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": "33342-280_d520c66f-440c-4f7e-b057-0d548c3142e7",
"productndc": "33342-280",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207292",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE;160MG",
"product_no": "001",
"approval_date": "Oct 11, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE;160MG",
"product_no": "002",
"approval_date": "Oct 11, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE;320MG",
"product_no": "003",
"approval_date": "Oct 11, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE;320MG",
"product_no": "004",
"approval_date": "Oct 11, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMLODIPINE BESYLATE; VALSARTAN",
"shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
"shortage_status": "current",
"proprietary_name": "amlodipine and valsartan",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA207292",
"marketing_category": "ANDA",
"nonproprietary_name": "amlodipine and valsartan",
"start_marketing_date": "20241016",
"active_numerator_strength": "10; 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
Access this data programmatically
Query amlodipine and valsartan and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.