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United States · US · US:68180-765_e0777a79-35ef-4f69-b6ac-94d31f7ca6fb

Amlodipine and Valsartan

In shortageOrange BookUNIISPLATC C08CA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC08CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A090245
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": "68180-765_e0777a79-35ef-4f69-b6ac-94d31f7ca6fb",
  "productndc": "68180-765",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090245",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 5MG BASE;160MG",
        "product_no": "001",
        "approval_date": "Mar 30, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 10MG BASE;160MG",
        "product_no": "002",
        "approval_date": "Mar 30, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 5MG BASE;320MG",
        "product_no": "003",
        "approval_date": "Mar 30, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 10MG BASE;320MG",
        "product_no": "004",
        "approval_date": "Mar 30, 2015"
      }
    ],
    "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": "ANDA090245",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amlodipine and Valsartan",
  "start_marketing_date": "20150331",
  "active_numerator_strength": "10; 160"
}

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