Losartan Potassium 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
4670844810
100 BLISTER PACK in 1 CARTON (46708-448-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
4670844830
30 TABLET, FILM COATED in 1 BOTTLE (46708-448-30)
ndc11
4670844890
90 TABLET, FILM COATED in 1 BOTTLE (46708-448-90)
ndc11
4670844891
1000 TABLET, FILM COATED in 1 BOTTLE (46708-448-91)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A091617

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": {
    "5f7612dc-dccf-49e2-b541-3dab9dc1f97a": {
      "match": "brand_token",
      "title": "LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "30",
      "published_date": "2026-06-01"
    }
  },
  "productid": "46708-448_d80ae5dd-3bdc-40a4-9589-dfb7f8eabe6d",
  "productndc": "46708-448",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091617",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;50MG",
        "product_no": "001",
        "approval_date": "Feb 17, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;100MG",
        "product_no": "002",
        "approval_date": "Feb 17, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;100MG",
        "product_no": "003",
        "approval_date": "Feb 17, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM",
  "shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Losartan Potassium and Hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA091617",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Losartan Potassium and Hydrochlorothiazide",
  "start_marketing_date": "20160523",
  "active_numerator_strength": "12.5; 50"
}

Related drugs

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