Diovan

In shortageOrange BookUNIISPLATC C09CA03

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

Identification

ManufacturerNovartis Pharmaceuticals Corporation

CountryUS (United States)

ATC codeC09CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0078125934
90 TABLET in 1 BOTTLE (0078-1259-34)

Annotations

UNII (FDA Substance ID)

80M03YXJ7I

VALSARTAN

RxCUI 69749

Orange Book

N021283

ABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Valsartan Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "80M03YXJ7I",
    "rxcui": "69749",
    "inchikey": "ACWBQPMHZXGDFX-QFIPXVFZSA-N",
    "display_name": "VALSARTAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d76a0419-05ee-437e-884c-65807aea9569": {
      "match": "brand_token",
      "title": "DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "34",
      "published_date": "2026-02-16"
    }
  },
  "productid": "0078-1259_bb542e5b-0b85-45db-8542-e203b9cd8618",
  "productndc": "0078-1259",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021283",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "001",
        "approval_date": "Jul 18, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "160MG",
        "product_no": "002",
        "approval_date": "Jul 18, 2001"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "320MG",
        "product_no": "003",
        "approval_date": "Jul 18, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "004",
        "approval_date": "Aug 14, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VALSARTAN",
  "shortage_reason": "Valsartan Tablet",
  "shortage_status": "current",
  "proprietary_name": "Diovan",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021283",
  "marketing_category": "NDA",
  "nonproprietary_name": "valsartan",
  "start_marketing_date": "20010701",
  "active_numerator_strength": "320"
}

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