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United States · US · US:64380-215_1da81b6e-f1da-46de-8396-592cd855801b
Amlodipine and Valsartan
Orange BookUNIISPLATC C08CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeC08CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11643802150130 TABLET in 1 BOTTLE, PLASTIC (64380-215-01)
- ndc11643802150290 TABLET in 1 BOTTLE, PLASTIC (64380-215-02)
Annotations
UNII (FDA Substance ID)
1J444QC288
AMLODIPINE
RxCUI 17767
Orange Book
A090011
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1J444QC288",
"rxcui": "17767",
"inchikey": "HTIQEAQVCYTUBX-UHFFFAOYSA-N",
"display_name": "AMLODIPINE",
"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": "64380-215_1da81b6e-f1da-46de-8396-592cd855801b",
"productndc": "64380-215",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "090011",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE;160MG",
"product_no": "001",
"approval_date": "Mar 28, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE;160MG",
"product_no": "002",
"approval_date": "Mar 28, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE;320MG",
"product_no": "003",
"approval_date": "Mar 28, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE;320MG",
"product_no": "004",
"approval_date": "Mar 28, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMLODIPINE; VALSARTAN",
"proprietary_name": "Amlodipine and Valsartan",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA090011",
"marketing_category": "ANDA",
"nonproprietary_name": "amlodipine and valsartan",
"start_marketing_date": "20221024",
"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
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