Amlodipine and valsartan

In shortageOrange BookUNIISPLATC C08CA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeC08CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6586273803
3 BLISTER PACK in 1 CARTON (65862-738-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-738-10)
ndc11
6586273830
30 TABLET, FILM COATED in 1 BOTTLE (65862-738-30)
ndc11
6586273890
90 TABLET, FILM COATED in 1 BOTTLE (65862-738-90)

Annotations

UNII (FDA Substance ID)

864V2Q084H

AMLODIPINE BESYLATE

RxCUI 104416

Orange Book

A206512

ABABABAB

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": "65862-738_909d72a6-7116-407e-8ec8-77b9b5798237",
  "productndc": "65862-738",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206512",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;160MG",
        "product_no": "001",
        "approval_date": "Apr 22, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;320MG",
        "product_no": "002",
        "approval_date": "Apr 22, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;160MG",
        "product_no": "003",
        "approval_date": "Apr 22, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;320MG",
        "product_no": "004",
        "approval_date": "Apr 22, 2016"
      }
    ],
    "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": "ANDA206512",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amlodipine and valsartan",
  "start_marketing_date": "20160422",
  "active_numerator_strength": "5; 320"
}

Related drugs

Other records sharing ATC code C08CA.

Access this data programmatically

Query Amlodipine and valsartan and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs