AMLODIPINE BESYLATE

In shortageOrange BookUNIISPLATC C08CA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC08CA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7278926230
30 TABLET in 1 BOTTLE, PLASTIC (72789-262-30)
ndc11
7278926260
60 TABLET in 1 BOTTLE, PLASTIC (72789-262-60)
ndc11
7278926290
90 TABLET in 1 BOTTLE, PLASTIC (72789-262-90)
ndc11
7278926295
1000 TABLET in 1 BOTTLE, PLASTIC (72789-262-95)

Annotations

UNII (FDA Substance ID)

864V2Q084H

AMLODIPINE BESYLATE

RxCUI 104416

Orange Book

A078414

ABABAB

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": "72789-262_41d6707a-c54e-5987-e063-6294a90ab185",
  "productndc": "72789-262",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078414",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Apr 7, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Apr 7, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "003",
        "approval_date": "Apr 7, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE",
  "shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
  "shortage_status": "current",
  "proprietary_name": "AMLODIPINE BESYLATE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078414",
  "marketing_category": "ANDA",
  "nonproprietary_name": "AMLODIPINE BESYLATE",
  "start_marketing_date": "20211001",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C08CA01.

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