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United States · US · US:51407-858_508d4d92-abe0-6182-e063-6394a90a7bcc

amlodipine besylate and olmesartan medoxomil

In shortageOrange BookUNIISPLATC C08CA

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

Identification

ManufacturerGolden State Medical Supply, Inc.
CountryUS (United States)
ATC codeC08CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5140785830
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-858-30)

Annotations

UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
N022100
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": "51407-858_508d4d92-abe0-6182-e063-6394a90a7bcc",
  "productndc": "51407-858",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "022100",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;20MG",
        "product_no": "001",
        "approval_date": "Sep 26, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;40MG",
        "product_no": "002",
        "approval_date": "Sep 26, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;20MG",
        "product_no": "003",
        "approval_date": "Sep 26, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;40MG",
        "product_no": "004",
        "approval_date": "Sep 26, 2007"
      }
    ],
    "appl_type": "N"
  },
  "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": "NDA022100",
  "marketing_category": "NDA",
  "nonproprietary_name": "amlodipine besylate and olmesartan medoxomil",
  "start_marketing_date": "20070926",
  "active_numerator_strength": "10; 20"
}

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