Back to search
🇺🇸

United States · US · US:70436-017_d306cb9e-4244-49dd-9297-9cb6ca69cae9

olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide

In shortageOrange BookUNIISPLATC C08CA

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

Identification

ManufacturerSlate Run Pharmaceuticals, LLC
CountryUS (United States)
ATC codeC08CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7043601704
    30 TABLET, FILM COATED in 1 BOTTLE (70436-017-04)
  • ndc11
    7043601706
    90 TABLET, FILM COATED in 1 BOTTLE (70436-017-06)

Annotations

UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A210718
ABABABABAB
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": {
    "7f78d14a-acf2-4f82-9d20-dfcbd5e9ffb3": {
      "match": "brand_token",
      "title": "OLMESARTAN MEDOXOMIL TABLET [A-S MEDICATION SOLUTIONS]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "70436-017_d306cb9e-4244-49dd-9297-9cb6ca69cae9",
  "productndc": "70436-017",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210718",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;12.5MG;20MG",
        "product_no": "001",
        "approval_date": "May 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;12.5MG;40MG",
        "product_no": "002",
        "approval_date": "May 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;25MG;40MG",
        "product_no": "003",
        "approval_date": "May 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;12.5MG;40MG",
        "product_no": "004",
        "approval_date": "May 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;25MG;40MG",
        "product_no": "005",
        "approval_date": "May 14, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
  "shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
  "shortage_status": "current",
  "proprietary_name": "olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA210718",
  "marketing_category": "ANDA",
  "nonproprietary_name": "olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide",
  "start_marketing_date": "20250515",
  "active_numerator_strength": "10; 12.5; 40"
}

Related drugs

Other records sharing ATC code C08CA.

Access this data programmatically

Query olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide 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.