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United States · US · US:27241-083_1c06acbb-7027-4b05-90a0-4f40c039c705

Amlodipine besylate and Olmesartan medoxomil

In shortageOrange BookUNIISPLATC C08CA

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

Identification

ManufacturerAjanta Pharma USA Inc.
CountryUS (United States)
ATC codeC08CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2724108303
    30 TABLET in 1 BOTTLE (27241-083-03)
  • ndc11
    2724108309
    90 TABLET in 1 BOTTLE (27241-083-09)

Annotations

UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A207216
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": "27241-083_1c06acbb-7027-4b05-90a0-4f40c039c705",
  "productndc": "27241-083",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207216",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;20MG",
        "product_no": "001",
        "approval_date": "Oct 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;40MG",
        "product_no": "002",
        "approval_date": "Oct 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;20MG",
        "product_no": "003",
        "approval_date": "Oct 28, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;40MG",
        "product_no": "004",
        "approval_date": "Oct 28, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
  "shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
  "shortage_status": "current",
  "proprietary_name": "Amlodipine besylate and Olmesartan medoxomil",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA207216",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amlodipine besylate and Olmesartan medoxomil",
  "start_marketing_date": "20170206",
  "active_numerator_strength": "5; 20"
}

Related drugs

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