Irbesartan and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4670844410
10 TABLET in 1 BLISTER PACK (46708-444-10)
ndc11
4670844430
30 TABLET in 1 BOTTLE (46708-444-30)
ndc11
4670844490
90 TABLET in 1 BOTTLE (46708-444-90)
ndc11
4670844491
1000 TABLET in 1 BOTTLE (46708-444-91)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A091370

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": "46708-444_bbfa2906-f126-40a2-a5c4-8cbe19388fcc",
  "productndc": "46708-444",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "091370",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;150MG",
        "product_no": "001",
        "approval_date": "Oct 15, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;300MG",
        "product_no": "002",
        "approval_date": "Oct 15, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;300MG",
        "product_no": "003",
        "approval_date": "Oct 12, 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": "ANDA091370",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Irbesartan and Hydrochlorothiazide",
  "start_marketing_date": "20160523",
  "active_numerator_strength": "25; 300"
}

Related drugs

Other records sharing ATC code C03AA.

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