Lisinopril 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 · 5

ndc11
6586204300
100 TABLET in 1 BOTTLE (65862-043-00)
ndc11
6586204301
100 TABLET in 1 BOTTLE (65862-043-01)
ndc11
6586204305
500 TABLET in 1 BOTTLE (65862-043-05)
ndc11
6586204330
30 TABLET in 1 BOTTLE (65862-043-30)
ndc11
6586204399
1000 TABLET in 1 BOTTLE (65862-043-99)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A077606

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": {
    "ab561d21-7466-4d8b-8d06-291c1d4d82ff": {
      "match": "brand_token",
      "title": "LISINOPRIL TABLET [PREFERRED PHARMACEUTICALS INC.]",
      "spl_version": "9",
      "published_date": "2026-06-01"
    }
  },
  "productid": "65862-043_5e2383b2-8c0d-450f-b681-74bfb12942a7",
  "productndc": "65862-043",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077606",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;10MG",
        "product_no": "001",
        "approval_date": "Mar 14, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;20MG",
        "product_no": "002",
        "approval_date": "Mar 14, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;20MG",
        "product_no": "003",
        "approval_date": "Mar 14, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCHLOROTHIAZIDE; LISINOPRIL",
  "shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Lisinopril and Hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA077606",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lisinopril and Hydrochlorothiazide",
  "start_marketing_date": "20060314",
  "active_numerator_strength": "12.5; 10"
}

Related drugs

Other records sharing ATC code C03AA.

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