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United States · US · US:46708-213_cbb564d2-add9-430a-a36b-45147d417138

Amlodipine besylate and Olmesartran medoxomil

In shortageOrange BookUNIISPLATC C08CA

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

Identification

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

Packs · 3

  • ndc11
    4670821330
    30 TABLET, FILM COATED in 1 BOTTLE (46708-213-30)
  • ndc11
    4670821390
    90 TABLET, FILM COATED in 1 BOTTLE (46708-213-90)
  • ndc11
    4670821391
    1000 TABLET, FILM COATED in 1 BOTTLE (46708-213-91)

Annotations

UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A207073
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": "46708-213_cbb564d2-add9-430a-a36b-45147d417138",
  "productndc": "46708-213",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "207073",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;20MG",
        "product_no": "001",
        "approval_date": "Jul 17, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;40MG",
        "product_no": "002",
        "approval_date": "Jul 17, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;20MG",
        "product_no": "003",
        "approval_date": "Jul 17, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;40MG",
        "product_no": "004",
        "approval_date": "Jul 17, 2017"
      }
    ],
    "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 Olmesartran medoxomil",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA207073",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amlodipine besylate and Olmesartran medoxomil",
  "start_marketing_date": "20170718",
  "active_numerator_strength": "5; 40"
}

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