Irbesartan and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6586263005
500 TABLET, FILM COATED in 1 BOTTLE (65862-630-05)
ndc11
6586263030
30 TABLET, FILM COATED in 1 BOTTLE (65862-630-30)
ndc11
6586263090
90 TABLET, FILM COATED in 1 BOTTLE (65862-630-90)
ndc11
6586263099
1000 TABLET, FILM COATED in 1 BOTTLE (65862-630-99)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A203630

ABABAB

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": "65862-630_6f7c3d7b-9b7c-447e-8763-f68a55ce4b91",
  "productndc": "65862-630",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203630",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;150MG",
        "product_no": "001",
        "approval_date": "Feb 22, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;300MG",
        "product_no": "002",
        "approval_date": "Feb 22, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;300MG",
        "product_no": "003",
        "approval_date": "Mar 31, 2016"
      }
    ],
    "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": "ANDA203630",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Irbesartan and Hydrochlorothiazide",
  "start_marketing_date": "20130222",
  "active_numerator_strength": "12.5; 300"
}

Related drugs

Other records sharing ATC code C03AA.

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