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United States · US · US:68462-568_6de4a776-9973-4410-ae04-99544813d920
Amlodipine and Olmesartan Medoxomil
In shortageOrange BookUNIISPLATC C08CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeC08CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11684625681410 BLISTER PACK in 1 CARTON (68462-568-14) / 10 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11684625683030 TABLET, FILM COATED in 1 BOTTLE (68462-568-30)
- ndc11684625689090 TABLET, FILM COATED in 1 BOTTLE (68462-568-90)
Annotations
UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A207807
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": "68462-568_6de4a776-9973-4410-ae04-99544813d920",
"productndc": "68462-568",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "207807",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 5MG BASE;20MG",
"product_no": "001",
"approval_date": "Jul 5, 2017"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 5MG BASE;40MG",
"product_no": "002",
"approval_date": "Jul 5, 2017"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 10MG BASE;20MG",
"product_no": "003",
"approval_date": "Jul 5, 2017"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 10MG BASE;40MG",
"product_no": "004",
"approval_date": "Jul 5, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
"shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
"shortage_status": "current",
"proprietary_name": "Amlodipine and Olmesartan Medoxomil",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA207807",
"marketing_category": "ANDA",
"nonproprietary_name": "Amlodipine and Olmesartan Medoxomil",
"start_marketing_date": "20170705",
"active_numerator_strength": "5; 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
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