Valsartan

In shortageOrange BookUNIISPLATC C09CA03

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

Identification

ManufacturerAmerican Health Packaging

CountryUS (United States)

ATC codeC09CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6068761221
30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-612-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-612-11)

Annotations

UNII (FDA Substance ID)

80M03YXJ7I

VALSARTAN

RxCUI 69749

Orange Book

A205536

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": "60687-612_23562661-facc-865c-e063-6394a90af4c0",
  "productndc": "60687-612",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205536",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Mar 12, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "002",
        "approval_date": "Mar 12, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "160MG",
        "product_no": "003",
        "approval_date": "Mar 12, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "320MG",
        "product_no": "004",
        "approval_date": "Mar 12, 2019"
      }
    ],
    "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": "ANDA205536",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Valsartan",
  "start_marketing_date": "20210623",
  "active_numerator_strength": "40"
}

Related drugs

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