Irbesartan and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerUnichem Pharmaceuticals (USA), Inc.

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
2930021610
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-10)
ndc11
2930021613
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-13)
ndc11
2930021619
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-19)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A207018

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": {
    "85494404-484c-45a1-8487-f9eb2a76490d": {
      "match": "brand_token",
      "title": "IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2026-06-01"
    }
  },
  "productid": "29300-216_a2e7c9d1-50c4-4a14-8dd5-8dfc6d63a29a",
  "productndc": "29300-216",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "207018",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "12.5MG;150MG",
        "product_no": "001",
        "approval_date": "Sep 19, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "12.5MG;300MG",
        "product_no": "002",
        "approval_date": "Sep 19, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCHLOROTHIAZIDE; IRBESARTAN",
  "shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Irbesartan and Hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA207018",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Irbesartan and Hydrochlorothiazide",
  "start_marketing_date": "20170919",
  "active_numerator_strength": "12.5; 300"
}

Related drugs

Other records sharing ATC code C03AA.

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