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United States · US · US:23155-844_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

  • ndc11
    2315584403
    30 TABLET in 1 BOTTLE, PLASTIC (23155-844-03)
  • ndc11
    2315584409
    90 TABLET in 1 BOTTLE, PLASTIC (23155-844-09)

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": "23155-844_a1e93c2f-051c-40b9-a0ba-bfcf78a9c2d4",
  "productndc": "23155-844",
  "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; 160"
}

Related drugs

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