Valsartan

In shortageOrange BookUNIISPLATC C09CA03

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC

CountryUS (United States)

ATC codeC09CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5374683805
500 TABLET in 1 BOTTLE (53746-838-05)
ndc11
5374683810
1000 TABLET in 1 BOTTLE (53746-838-10)
ndc11
5374683890
90 TABLET in 1 BOTTLE (53746-838-90)

Annotations

UNII (FDA Substance ID)

80M03YXJ7I

VALSARTAN

RxCUI 69749

Orange Book

A204011

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": {
    "26080940-bcd3-446d-9026-3ddfb58e281e": {
      "match": "brand_token",
      "title": "VALSARTAN TABLET [SOLCO HEALTHCARE US, LLC]",
      "spl_version": "13",
      "published_date": "2026-04-30"
    }
  },
  "productid": "53746-838_254b9473-bbcb-4780-a182-ba287b886a47",
  "productndc": "53746-838",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204011",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Jan 11, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "002",
        "approval_date": "Jan 11, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "160MG",
        "product_no": "003",
        "approval_date": "Jan 11, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "320MG",
        "product_no": "004",
        "approval_date": "Jan 11, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VALSARTAN",
  "shortage_reason": "Valsartan Tablet",
  "shortage_status": "current",
  "proprietary_name": "Valsartan",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204011",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Valsartan",
  "start_marketing_date": "20230801",
  "active_numerator_strength": "80"
}

Related drugs

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