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United States · US · US:70954-522_d6ace9b2-f8fa-42b9-8338-9e2b5519ef6b

INZIRQO

In shortageOrange BookUNIISPLATC C03AX01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC03AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7095452210
    80 mL in 1 BOTTLE (70954-522-10)

Annotations

UNII (FDA Substance ID)
0J48LPH2TH
HYDROCHLOROTHIAZIDE
RxCUI 5487
Orange Book
N219141
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Hydrochlorothiazide Capsule
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": {
    "41aaea48-6c1b-42c8-a96f-5923d49dc934": {
      "match": "brand_token",
      "title": "INZIRQO (HYDROCHLOROTHIAZIDE) POWDER, FOR SUSPENSION [ANI PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2025-12-18"
    }
  },
  "productid": "70954-522_d6ace9b2-f8fa-42b9-8338-9e2b5519ef6b",
  "productndc": "70954-522",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "219141",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Jan 28, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCHLOROTHIAZIDE",
  "shortage_reason": "Hydrochlorothiazide Capsule",
  "shortage_status": "current",
  "proprietary_name": "INZIRQO",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA219141",
  "marketing_category": "NDA",
  "nonproprietary_name": "hydrochlorothiazide",
  "start_marketing_date": "20250130",
  "active_numerator_strength": "10"
}

Related drugs

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