Valsartan and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009053450
90 TABLET, FILM COATED in 1 BOTTLE (50090-5345-0)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A203145

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": "50090-5345_48d61518-d6f5-4b1e-8d5f-88cdd766a17d",
  "productndc": "50090-5345",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203145",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;80MG",
        "product_no": "001",
        "approval_date": "Apr 19, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;160MG",
        "product_no": "002",
        "approval_date": "Apr 19, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;320MG",
        "product_no": "003",
        "approval_date": "Apr 19, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;160MG",
        "product_no": "004",
        "approval_date": "Apr 19, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;320MG",
        "product_no": "005",
        "approval_date": "Apr 19, 2013"
      }
    ],
    "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": "ANDA203145",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Valsartan and Hydrochlorothiazide",
  "start_marketing_date": "20130419",
  "active_numerator_strength": "25; 320"
}

Related drugs

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