Telmisartan and Amlodipine

In shortageOrange BookUNIISPLATC C08CA

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeC08CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378107793
30 TABLET in 1 BOTTLE, PLASTIC (0378-1077-93)

Annotations

UNII (FDA Substance ID)

864V2Q084H

AMLODIPINE BESYLATE

RxCUI 104416

Orange Book

A202516

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": {
    "a5ded796-3555-4476-8b37-0cdc88d7594a": {
      "match": "brand_token",
      "title": "TELMISARTAN TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "102",
      "published_date": "2026-05-25"
    }
  },
  "productid": "0378-1077_c4f4323d-671d-478b-b088-008530932cee",
  "productndc": "0378-1077",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202516",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 5MG BASE;40MG",
        "product_no": "001",
        "approval_date": "Aug 26, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 10MG BASE;40MG",
        "product_no": "002",
        "approval_date": "Aug 26, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 5MG BASE;80MG",
        "product_no": "003",
        "approval_date": "Aug 26, 2014"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 10MG BASE;80MG",
        "product_no": "004",
        "approval_date": "Aug 26, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE; TELMISARTAN",
  "shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
  "shortage_status": "current",
  "proprietary_name": "Telmisartan and Amlodipine",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA202516",
  "marketing_category": "ANDA",
  "nonproprietary_name": "telmisartan and amlodipine",
  "start_marketing_date": "20140919",
  "active_numerator_strength": "5; 80"
}

Related drugs

Other records sharing ATC code C08CA.

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