Back to search
🇺🇸

United States · US · US:42291-003_48480a71-5c94-91ab-e063-6294a90a656d

Amlodipine and Olmesartan Medoxomil

In shortageOrange BookUNIISPLATC C08CA

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

Identification

ManufacturerAvKARE
CountryUS (United States)
ATC codeC08CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4229100330
    30 TABLET, FILM COATED in 1 BOTTLE (42291-003-30)

Annotations

UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A209010
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": "42291-003_48480a71-5c94-91ab-e063-6294a90a656d",
  "productndc": "42291-003",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209010",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;20MG",
        "product_no": "001",
        "approval_date": "Dec 3, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;40MG",
        "product_no": "002",
        "approval_date": "Dec 3, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;20MG",
        "product_no": "003",
        "approval_date": "Dec 3, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;40MG",
        "product_no": "004",
        "approval_date": "Dec 3, 2018"
      }
    ],
    "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 and Olmesartan Medoxomil",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA209010",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amlodipine and Olmesartan Medoxomil",
  "start_marketing_date": "20240618",
  "active_numerator_strength": "10; 20"
}

Related drugs

Other records sharing ATC code C08CA.

Access this data programmatically

Query Amlodipine and Olmesartan Medoxomil 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.