Amlodipine Besylate

In shortageOrange BookUNIISPLATC C08CA01

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeC08CA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7133531261
30 TABLET in 1 BOTTLE (71335-3126-1)
ndc11
7133531262
90 TABLET in 1 BOTTLE (71335-3126-2)
ndc11
7133531263
120 TABLET in 1 BOTTLE (71335-3126-3)
ndc11
7133531264
60 TABLET in 1 BOTTLE (71335-3126-4)
ndc11
7133531265
500 TABLET in 1 BOTTLE (71335-3126-5)
ndc11
7133531266
10 TABLET in 1 BOTTLE (71335-3126-6)
ndc11
7133531267
100 TABLET in 1 BOTTLE (71335-3126-7)
ndc11
7133531268
180 TABLET in 1 BOTTLE (71335-3126-8)

Annotations

UNII (FDA Substance ID)

864V2Q084H

AMLODIPINE BESYLATE

RxCUI 104416

Orange Book

A078925

ABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Amlodipine Besylate; Benazepril Hydrochloride Capsule

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": "71335-3126_2abdb000-40fa-48e8-8e70-c4ebd885d810",
  "productndc": "71335-3126",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078925",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "May 4, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "May 4, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "003",
        "approval_date": "May 4, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE",
  "shortage_reason": "Amlodipine Besylate; Benazepril Hydrochloride Capsule",
  "shortage_status": "current",
  "proprietary_name": "Amlodipine Besylate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078925",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amlodipine besylate",
  "start_marketing_date": "20251206",
  "active_numerator_strength": "2.5"
}

Related drugs

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