Valsartan

In shortageOrange BookUNIISPLATC C09CA03

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

Identification

ManufacturerLaurus Labs Limited

CountryUS (United States)

ATC codeC09CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4238599205
500 TABLET, FILM COATED in 1 BOTTLE (42385-992-05)
ndc11
4238599230
30 TABLET, FILM COATED in 1 BOTTLE (42385-992-30)
ndc11
4238599268
10 BLISTER PACK in 1 CARTON (42385-992-68) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-992-10)
ndc11
4238599290
90 TABLET, FILM COATED in 1 BOTTLE (42385-992-90)

Annotations

UNII (FDA Substance ID)

80M03YXJ7I

VALSARTAN

RxCUI 69749

Orange Book

A218897

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": "42385-992_6e1f63ad-e554-421b-a699-4e8c9bd4d239",
  "productndc": "42385-992",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218897",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Apr 21, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "002",
        "approval_date": "Apr 21, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "160MG",
        "product_no": "003",
        "approval_date": "Apr 21, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "320MG",
        "product_no": "004",
        "approval_date": "Apr 21, 2026"
      }
    ],
    "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": "ANDA218897",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Valsartan",
  "start_marketing_date": "20260422",
  "active_numerator_strength": "320"
}

Related drugs

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