Valsartan and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerAvKARE

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4229196590
90 TABLET, FILM COATED in 1 BOTTLE (42291-965-90)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A204382

ABABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Hydrochlorothiazide; Quinapril Hydrochloride Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "0J48LPH2TH",
    "rxcui": "5487",
    "inchikey": "JZUFKLXOESDKRF-UHFFFAOYSA-N",
    "display_name": "HYDROCHLOROTHIAZIDE",
    "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": "42291-965_48c2dd05-3fd2-f936-e063-6294a90ad6eb",
  "productndc": "42291-965",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204382",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;80MG",
        "product_no": "001",
        "approval_date": "Aug 11, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;160MG",
        "product_no": "002",
        "approval_date": "Aug 11, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;160MG",
        "product_no": "003",
        "approval_date": "Aug 11, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;320MG",
        "product_no": "004",
        "approval_date": "Aug 11, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;320MG",
        "product_no": "005",
        "approval_date": "Aug 11, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCHLOROTHIAZIDE; VALSARTAN",
  "shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Valsartan and Hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA204382",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Valsartan and Hydrochlorothiazide",
  "start_marketing_date": "20230919",
  "active_numerator_strength": "12.5; 80"
}

Related drugs

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