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United States · US · US:71335-0218_9f46a706-45ec-400f-9a85-eacceab1ed05

AMLODIPINE BESYLATE

In shortageOrange BookUNIISPLATC C08CA01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC08CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    7133502180
    7 TABLET in 1 BOTTLE (71335-0218-0)
  • ndc11
    7133502181
    30 TABLET in 1 BOTTLE (71335-0218-1)
  • ndc11
    7133502182
    90 TABLET in 1 BOTTLE (71335-0218-2)
  • ndc11
    7133502183
    60 TABLET in 1 BOTTLE (71335-0218-3)
  • ndc11
    7133502184
    120 TABLET in 1 BOTTLE (71335-0218-4)
  • ndc11
    7133502185
    100 TABLET in 1 BOTTLE (71335-0218-5)
  • ndc11
    7133502186
    800 TABLET in 1 BOTTLE (71335-0218-6)
  • ndc11
    7133502187
    1000 TABLET in 1 BOTTLE (71335-0218-7)
  • ndc11
    7133502188
    180 TABLET in 1 BOTTLE (71335-0218-8)
  • ndc11
    7133502189
    10 TABLET in 1 BOTTLE (71335-0218-9)

Annotations

UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A077073
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": "71335-0218_9f46a706-45ec-400f-9a85-eacceab1ed05",
  "productndc": "71335-0218",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077073",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Sep 26, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Sep 26, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "003",
        "approval_date": "Sep 26, 2007"
      }
    ],
    "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": "ANDA077073",
  "marketing_category": "ANDA",
  "nonproprietary_name": "AMLODIPINE BESYLATE",
  "start_marketing_date": "20070926",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C08CA01.

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