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United States · US · US:23155-846_a1e93c2f-051c-40b9-a0ba-bfcf78a9c2d4
Amlodipine and Valsartan
Orange BookUNIISPLATC C08CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC08CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11231558460330 TABLET in 1 BOTTLE, PLASTIC (23155-846-03)
- ndc11231558460990 TABLET in 1 BOTTLE, PLASTIC (23155-846-09)
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": "23155-846_a1e93c2f-051c-40b9-a0ba-bfcf78a9c2d4",
"productndc": "23155-846",
"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": "20230315",
"active_numerator_strength": "5; 320"
}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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